Motion Serifos: a Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants affected by motion sickness during travel

开始日期2023-09-09

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06138613 / Recruiting临床3期

Motion Delos: An Open Label Study to Investigate the Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

开始日期2023-02-27

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05653310 / Enrolling by invitation临床2期IIT

Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia

To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.

开始日期2023-02-09

申办/合作机构

Mayo Clinic

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项与曲地匹坦相关的文献（医药）

2024-12-01·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial

Article

作者: Moszczynski, Paula ; Polymeropoulos, Mihael H ; Fisher, Michaela ; Polymeropoulos, Christos ; Birznieks, Gunther ; Madonick, Darby ; Kupersmith, Caleigh ; Carlin, Jesse L ; Xiao, Changfu ; Camilleri, Michael ; Smieszek, Sandra ; Lembo, Anthony

BACKGROUND:

Neurokinin receptor 1 antagonists are effective in reducing nausea and vomiting in chemotherapy-induced emesis. We investigated the safety and efficacy of tradipitant, a neurokinin receptor 1 antagonist, in patients with idiopathic and diabetic gastroparesis.

METHODS:

A total of 201 adults with gastroparesis were randomly assigned to oral tradipitant 85 mg (n = 102) or placebo (n = 99) twice daily for 12 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. Blood levels were monitored for an exposure-response analysis. The primary outcome was change from baseline to week 12 in average nausea severity, measured by daily symptom diary.

RESULTS:

The intention-to-treat (ITT) population did not meet the prespecified primary endpoint at week 12 (difference in nausea severity change drug vs placebo; P = .741) or prespecified secondary endpoints. Post hoc analyses were performed to control for drug exposure, rescue medications, and baseline severity inflation. Subjects with high blood levels of tradipitant significantly improved average nausea severity beginning at early time points (weeks 2-4). In post hoc sensitivity analyses, tradipitant treatment demonstrated strengthened effects, with statistically significant improvements in nausea at week 12.

CONCLUSIONS:

Although tradipitant did not reach significance in the ITT population, a pharmacokinetic exposure-response analysis demonstrated significant effects with adequate tradipitant exposure. When accounting for confounding factors such as baseline severity inflation and rescue medication, a statistically significant effect was also observed. These findings suggest that tradipitant has potential as a treatment for the symptom of nausea in gastroparesis. (ClincialTrials.gov, Number: NCT04028492).

2023-09-07·Cureus

Diabetic Gastroparesis and its Emerging Therapeutic Options: A Narrative Review of the Literature

Review

作者: Tated, Ritu ; Karnik, Siddhant B ; Jacob, Fredy P ; Pramod Roy, Akshara ; Zahid, Shiza A ; Mathew, Midhun ; Khawaja, Uzzam Ahmed ; Razzaq, Waleed ; Shivakumar, Divya ; Baskara Salian, Rishabh ; Rajkumar, Daniel

Diabetic gastroparesis (DG) is one of the many complications of diabetes mellitus (DM). Even though this condition surfaces years after uncontrolled disease, it affects the quality of life in several ways and causes significant morbidity. Common symptoms experienced by the patients include postprandial nausea, vomiting, abdominal fullness, and pain. Strict glycemic control is essential to evade the effects of DG. The purpose of this review article is to briefly study the pathophysiology, clinical features, diagnostic modalities, and the effects of DG on different aspects of life. Furthermore, it also focuses on the emerging treatment modalities for DG. Tradipitant and relamorelin are two such treatment options that are gaining noteworthy recognition and are discussed in detail in this review article. As observed through various clinical trials, these drugs help alleviate symptoms like nausea, vomiting, abdominal pain, and bloating in patients suffering from DG, thereby targeting the most common and bothersome symptoms of the disease. This leads to an improvement in the quality of life, making it a reliable treatment option for this disease. But while pharmacological intervention is vital, psychological support and lifestyle changes are equally important and are the reason why a multidisciplinary approach is required for the treatment of DG.

2022-07-01·Alimentary pharmacology & therapeutics

Clinical trial: a single‐centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers

Article

作者: Harmsen, William S. ; Torres, Monique ; Xiao, Michael ; Khanna, Lehar ; Zheng, Ting ; Camilleri, Michael ; Atieh, Jessica ; Carlin, Jesse L. ; Busciglio, Irene

Summary:

Background:

Tradipitant, an NK1 receptor antagonist, improved symptoms in patients with gastroparesis. It is unclear whether these effects are mediated centrally (e.g., vomiting centre) or on gastric functions. As a class, NK1 antagonists may retard gastric emptying (GE) or increase fasting and postprandial gastric volumes (GV).

Aim:

To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, postprandial symptoms, and pharmacokinetics.

Methods:

We conducted a randomised, double‐blind, placebo‐controlled, single‐centre study of tradipitant 85 mg or matching placebo b.i.d. for 9 consecutive days in 24 healthy volunteers. During the last 2 days of treatment, participants underwent scintigraphic measurements of GE of 320 kcal egg meal, fasting and postprandial GV by SPECT, and satiation by nutrient drink ingested to maximum tolerated volume (MTV) and symptoms 30 min later. Treatments were compared by Wilcoxon rank sum test. The study had 80% power to detect group differences of 23.6% in GV and 29.2% in GE T1/2.

Results:

The two groups of healthy participants were well balanced based on demographic features, age, and BMI. There were nonsignificant positive correlations between blood levels of tradipitant and accommodation GV and GE at 4 h. There were no significant effects of tradipitant, 85 mg b.i.d. for 9 days compared to placebo on GE, GV, satiation, or symptoms 30 min after MTV.

Conclusion:

Tradipitant, 85 mg b.i.d., does not significantly affect gastric motor functions (GV or GE). Importantly, there was no retardation of GE by tradipitant, which is important in relation to its potential use in patients with gastroparesis.

Clinic trials registry:

ClinicalTrials.gov #NCT04849559.

项与曲地匹坦相关的新闻（医药）

2024-12-24

·CPHI制药在线

治疗特应性皮炎的新兴药物一览

关注并星标CPHI制药在线特应性皮炎（atopic dermatitis，AD）又称“异位性皮炎”、“遗传过敏性皮炎”，是一种与遗传过敏素质有关的慢性、复发性、炎症性、瘙痒性皮肤病。常于婴儿期起病，累及儿童及青少年，临床异质性明显，受累部位随年龄变化，婴儿期渗出倾向明显，瘙痒剧烈，严重影响患儿睡眠质量及生长发育，进而影响患儿及整个家庭的生命质量。特应性皮炎患儿常伴有食物过敏、哮喘、过敏性鼻炎、过敏性结膜炎等特应性疾病的个人史或家族史，同时可有外周血嗜酸粒细胞增多、血清IgE水平升高。85％～90％的患者发病年龄<5 岁。我国的AD患病率总体呈上升趋势，皮损多见于面部及四肢伸侧或腘窝，为红斑、丘疹等多形性皮损。特应性皮炎的一线治疗方案为局部外用糖皮质激素，但疗效欠佳，目前的治疗方法仍有较多的局限性及不良反应，不能完全满足临床需求然而，对于一线和二线治疗无效的中重度特应性皮炎的治疗仍然存在挑战，而且只有少数局部抗炎药物可供选择，尤其是对儿童患者而言。近年来，随着对特应性皮炎复杂发病机制的深入研究，很多新药逐渐应用于治疗特应性皮炎，也有一些新药处于二期和三期临床实验阶段。 II期阶段的口服研发药物有哪些？ RPT193 RPT193 是一种口服的 4 型趋化因子受体（CCR4）拮抗剂。目前正处于II 期临床试验阶段，用于中度至重度 AD 成人患者。在免疫激活过程中，Th2 细胞通过与皮肤血管上的 CCL17 受体结合而迁移到皮肤上。同时，CCR4与肺部和皮肤中高浓度的 CCL22 相互作用，起到维持过敏过程的作用。RPT193 可阻断 CCR4 介导的细胞向受体 CCL17 和 CCL22 的趋化。I期试验中患者在每天服用 400 毫克以下剂量时均未发现严重不良反应。最常见的不良反应是头痛、恶心。随机双盲II期临床试验正在进行中。参试者分别服用 400 毫克口服片剂、200 毫克口服片剂、50 毫克口服片剂或安慰剂，每天服用一次，持续 16 周。 CBP-201 (rademikibart) CB-201 是一种靶向 IL-4 α受体的单克隆抗体，CB-201 可减少 TF-1 细胞的增殖。Ia 期临床试验健康患者，根据随机分组情况接受单剂量治疗（或安慰剂）；Ib 期是一项多剂量递增试验，参与者包括中度至重度注意力缺失症患者。这两项研究的主要结果是耐受性和安全性，次要结果是药代动力学和药效学。最常见的不良反应是头痛和上呼吸道感染，以及 AD 恶化。II期试验，其中包括来自多个国家的 226 名中度至重度 AD 成人患者，进一步评估疗效。主要结果是治疗 16 周时，EASI 评分从基线降低的百分比，次要结果是在服用 600 毫克负荷剂量 16 周后，IGA 达到 0 或 1 的参与者百分比。积极治疗组与安慰剂组相比，没有出现明显的治疗突发不良事件。常见的不良反应是头痛；不明原因的结膜炎为 3%。阿普司特 Apremilast 是一种口服 PDE4 抑制剂。在一项 IIa期双盲安慰剂对照试验，第 12 周时，40 毫克 BID 组的 EASI 降低了 32%， 30 毫克 BID 组的 EASI 降低了26%，在统计学上并不明显低于安慰剂。40 毫克 BID 组中有 6 名受试者出现蜂窝组织炎。40 毫克 BID 组中有六名受试者出现蜂窝组织炎，这导致该治疗组在研究期间终止。 LEO 138559 LEO 138559 是一种单克隆抗体，旨在阻断 IL22RA1受体亚基，从而抑制 IL-22 的作用。伊伐替尼（SHR0302） SHR0302 是一种口服 JAK1 抑制剂。该药物在进行一项随机、双盲、安慰剂对照的多中心 II期试验。治疗组各出现一例带状疱疹感染，与药物相关的治疗不良反应在 8 毫克组最高（40%），其次是安慰剂组（29%）和 4 毫克组（23%）。 ISB 830（telazorlimab/GBR830） Telazorlimab 是一种抗 OX40 单克隆抗体。不良反应包括麻痹、恶性贫血/中性粒细胞减少症和血小板减少症，导致泰拉曲利单抗组中的三名受试者停药。利桑珠单抗利桑珠单抗是一种抗 IL-23a 的单克隆抗体。它在一项II期、多中心、随机、双盲、安慰剂对照试验中，对 12 岁及以上的患者进行了测试、安慰剂对照试验。主要终点未达到，因为达到 EASI-90 的参与者比例之间没有明显的统计学差异。150毫克利桑珠单抗（25%）或300毫克利桑珠单抗(22%)与安慰剂(12%)相比没有统计学意义。 III期外用治疗药物有哪些？ Tapinarof Tapinarof 是一种外用芳基烃受体（AhR）调节剂。美国 FDA 批准用于治疗斑块状银屑病的外用药物。最近进行了两项III期临床试验、 ADORING 1 和 ADORING 2。参与者的年龄范围降低到了 2 岁及以上，并将评估时间与基线比较的评估时间缩短为 8 周。与安慰剂相比，在主要结果上有明显差异。苯维莫德苯维莫德乳膏是一种 AhR 激动剂，含有与他匹那罗乳膏相似的活性成分，但辅料不同（如凡士林油），而且需要每天用药两次，而不是每天一次。地拉米司特（OPA-15406） Difamilast (OPA-15406) 软膏是一种选择性 PDE4 抑制剂。儿童使用地拉米司特 0.3% 或 1%，每天两次，持续 4 周。在相同的时间段内只对成人进行了高剂量测试。与安慰剂相比，两种剂量的成功率明显更高。 Asivatrep (PAC-14028) Asivatrep 乳膏是一种瞬时受体潜在香草素 1（TRPV1）拮抗剂。在 240 名年龄≥12 岁的轻度和中度患者中进行了 III期双盲对照研究，效果明显优于对照组。小豆蔻和玫瑰单胞菌外用小豆蔻和玫瑰单胞菌是治疗 AD 的一种协同方法。抑制瞬时受体电位安基蛋白 1 (TRPA1) 的活化，并通过小豆蔻促进共生固氮作用。罗氟司特（ARQ-151）是一种 PDE4 抑制剂。轻度至中度 AD 的成人和儿童进行了III 期双盲载体对照试验。6岁的成人和轻度至中度AD患儿，浓度为0.15%，然后对2- 5 岁的儿童进行了浓度为 0.05% 的试验。罗氟司特不仅疗效显著，而且耐受性良好，这促使 FDA 批准了罗氟司特的补充新药申请。 III期阶段AD 的全身治疗药物有哪些？ Lebrikizumab Lebrikizumab 是一种靶向 IL-13 的单克隆抗体，其已被 FDA 快速批准为单一疗法。2018 年，Simpson 等人发表了一项随机、安慰剂对照、双盲研究在 18 岁及以上的成人中度至重度患者中进行比较的研究AD 使用局部皮质类固醇，2022 年，Silverberg 等人进行了两项随机、双盲、评估 Lebrikizumab 的安慰剂对照III 期试验。奈莫珠单抗（CIM331） Nemolizumab （CIM331）是一种靶向IL-31单克隆抗体，目前正在测试用于治疗中度至重度AD。IL-31 是一种认为具有致瘙痒的作用的细胞因子。 Amlitelimab 和 Rocatinlimab Amlitelimab 和 rocatinlimab 是全身性单克隆抗体，目前靶向 OX40-OX40L 通路的抗体。OX40-OX40L通路是免疫系统检查点的一部分，可以具有共刺激或抑制作用。 CM310 系列 CM310 是皮下给药，靶向 IL-4 受体的人源化单克隆抗体，阻断 IL-4/13 信号传导。CM310 在 120 名成人中重度 AD 已进行过 IIb 期试验。 Tradipitant （VLY-686） Tradipitant 是一种神经激肽-1 受体拮抗剂，减少 P 物质介导的瘙痒信号传导。Tradipitant 在III 期随机、安慰剂对照、针对 375 名轻度至重度 AD 成人患者的双盲试验。虽然 tradipitant 比安慰剂更能减轻瘙痒，它未能达到统计学上意义。地非利福林 Difelikefalin 是一种选择性的 κ-阿片受体激动剂，具有针对瘙痒症的作用。参考文献 1.Obed, O., Chong, A. C., Su, M., & Ong, P. Y. (2024). Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials. Expert opinion on emerging drugs, 29(3), 233–249. 2.Cho, S. I., & Na, J. I. (2024). Long-term observation to determine durable efficacy and safety of novel paediatric atopic dermatitis treatment, nemolizumab. The British journal of dermatology, ljae479. Advance online publication. END 【智药研习社近期直播】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

临床2期临床结果临床1期

2024-11-06

·PRNewswire

Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results

Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges Fanapt® launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 Fanapt® long acting injectable program expected to be initiated in Q4 2024 Milsaperidone NDA for schizophrenia and bipolar I disorder expected to be submitted in early 2025; initiation of major depressive disorder program expected in Q4 2024 PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024 PONVORY® IND applications for psoriasis and ulcerative colitis expected to be submitted in Q4 2024 Tradipitant NDA for motion sickness expected to be submitted in Q4 2024 WASHINGTON, Nov. 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2024. "We are very pleased with the lead indicators of the initial market response to our commercial launch of Fanapt in bipolar I disorder, a testament to the strong clinical evidence and the strength of our commercial strategy, and we look forward to continuous growth in the coming quarters. In parallel, we have launched Ponvory for multiple sclerosis and we are looking forward to increased prescriber and patient awareness in the near future. We expect Fanapt, milsaperidone and Fanapt LAI to form a diverse and expanding psychiatry franchise for years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "On the research and development front, we are focused on completing in the coming months our New Drug Applications for tradipitant in motion sickness and for milsaperidone in schizophrenia and bipolar I disorder. IND filings are expected to be completed for Ponvory in ulcerative colitis and psoriasis later this quarter. We are committed to growing our revenue from our existing products and continuing to diversify our sources of revenue through indication expansion and new product development." Financial Highlights Third Quarter of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $47.7 million in the third quarter of 2024, a 23% increase compared to $38.8 million in the third quarter of 2023. Fanapt® net product sales were $23.9 million in the third quarter of 2024, a 12% increase compared to $21.3 million in the third quarter of 2023. HETLIOZ® net product sales were $17.9 million in the third quarter of 2024, a 2% increase compared to $17.5 million in the third quarter of 2023. PONVORY® net product sales were $5.9 million in the third quarter of 2024, a decrease of 32% compared to $8.6 million in the second quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Cash, cash equivalents and marketable securities (Cash) was $376.3 million as of September 30, 2024, representing a decrease to Cash of $11.4 million compared to June 30, 2024. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. First Nine Months of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $145.6 million in the first nine months of 2024, a 1% decrease compared to $147.4 million in the first nine months of 2023. Fanapt® net product sales were $67.6 million in the first nine months of 2024, a 1% decrease compared to $68.3 million in the first nine months of 2023. HETLIOZ® net product sales were $56.6 million in the first nine months of 2024, a 28% decrease compared to $79.1 million in the first nine months of 2023. The decrease relative to the first nine months of 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $21.3 million in the first nine months of 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 2023. Net loss was $14.0 million in the first nine months of 2024, compared to net income of $4.9 million in the first nine months of 2023. Cash was $376.3 million as of September 30, 2024, representing a decrease to Cash of $12.0 million compared to December 31, 2023. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. Key Operational Highlights Psychiatry Portfolio Fanapt® (iloperidone): Vanda initiated the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults in the third quarter of 2024, which included the expansion of its existing sales force and the introduction of prescriber awareness and comprehensive marketing programs. Several lead indicators suggest a strong initial market response including new patient starts as reflected by new to brand prescriptions (NBRx),1 increasing by over 90% in the third quarter of 2024 as compared to the third quarter of 2023. Milsaperidone: Vanda expects to submit a New Drug Application (NDA) for milsaperidone (also known as VHX-896 and P-88), the active metabolite of Fanapt®, for the treatments of schizophrenia and acute bipolar I disorder to the U.S. Food and Drug Administration (FDA) in early 2025. Vanda expects to initiate a Phase III program for milsaperidone for major depressive disorder (MDD) by the end of 2024. Iloperidone long acting injectable (LAI): Vanda expects to initiate a Phase III program for the LAI formulation of Fanapt® in the fourth quarter of 2024. HETLIOZ® (tasimelteon) Vanda has initiated a HETLIOZ LQ® program in pediatric insomnia. Although the prevalence of insomnia in children is difficult to determine, it is estimated that 20-40% of children experience significant sleep problems.2,3 There are currently no approved treatments for pediatric insomnia. Vanda continues to pursue FDA approval for HETLIOZ® for the treatments of jet lag disorder and insomnia. Vanda is challenging the FDA's rejection of Vanda's supplemental New Drug Application (sNDA) for the treatment of jet lag disorder in the U.S. Court of Appeals for the D.C. Circuit. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the insomnia sNDA. Vanda's litigation asserting HETLIOZ® Patent No. 11,285,129 against generic manufacturers is currently pending in the U.S. District Court for the District of Delaware. A jury trial has been scheduled for the first quarter of 2026. European Medicines Agency action on Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome is expected in the first quarter of 2025. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024, which included the deployment of a specialty sales force. Vanda expects Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis to be completed in the fourth quarter of 2024. Tradipitant Gastroparesis NDA: In September 2024, the FDA declined to approve Vanda's NDA for tradipitant for the treatment of symptoms of gastroparesis. Vanda plans to continue to pursue the marketing authorization for tradipitant and support the expanded access program that is currently serving several dozen patients with gastroparesis. Motion Sickness NDA: Vanda expects to submit an NDA for tradipitant for the treatment of motion sickness to the FDA in the fourth quarter of 2024. The NDA for the treatment of motion sickness is expected to include the positive results of three placebo controlled clinical studies where tradipitant was effective in preventing vomiting associated with motion. Vanda plans to initiate a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog (semaglutide) in the fourth quarter of 2024. Early-Stage Programs Vanda plans to proceed with studies of VSJ-110, a CFTR activator, for the treatment of dry eye disorder. An ongoing proof of concept study indicates an effect in improving the signs (fluorescein corneal staining) of dry eye disease. VPO-227, a CFTR inhibitor for the treatment of cholera, has received approval to proceed in a Phase I study in Bangladesh, a country where the treatment of cholera remains a significant and unmet need. Vanda plans to initiate this study by the end of 2024. The Phase I clinical study for VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, expects to enroll the patient by the end of 2024. The Phase I clinical study for VTR-297 for the treatment of onychomycosis, a fungal infection of the nail, was initiated in April 2024. The study is fully enrolled, and results are expected by the end of 2024. VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. GAAP Financial Results Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Diluted net loss per share was $0.09 in the third quarter of 2024 compared to diluted net income per share of $0.00 in the third quarter of 2023. Net loss was $14.0 million in the first nine months of 2024 compared to net income of $4.9 million in the first nine months of 2023. Diluted net loss per share was $0.24 in the first nine months of 2024 compared to diluted net income per share of $0.09 in the first nine months of 2023. 2024 Financial Guidance Vanda is updating its 2024 financial guidance and expects to achieve the following financial objectives in 2024: Conference Call Vanda has scheduled a conference call for today, Wednesday, November 6, 2024, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2555000. A replay of the call will be available on Wednesday, November 6, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, November 13, 2024 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 2555000. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, Liao D, Bixler EO. Prevalence of insomnia symptoms in a general population sample of young children and preadolescents: gender effects. Sleep Med. 2014 Jan;15(1):91-5. doi: 10.1016/j.sleep.2013.08.787. Epub 2013 Oct 16. PMID: 24333223; PMCID: PMC3912735. Fricke-Oerkermann L, Plück J, Schredl M, Heinz K, Mitschke A, Wiater A, Lehmkuhl G. Prevalence and course of sleep problems in childhood. Sleep. 2007 Oct;30(10):1371-7. doi: 10.1093/sleep/30.10.1371. PMID: 17969471; PMCID: PMC2266270. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2024 Financial Guidance" above, and statements regarding Vanda's plans to strengthen and grow its business and diversify its sources of revenue; Vanda's plans for pursuit of FDA approval of milsaperidone for the treatments of schizophrenia and acute bipolar I disorder, tradipitant for the treatments of motion sickness and gastroparesis, and HETLIOZ® for the treatments of jet lag disorder and insomnia; European Medicines Agency action on the Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome; Vanda's clinical development plans for milsaperidone for the treatment of MDD, the LAI formulation of Fanapt®, PONVORY® for the treatments of psoriasis and ulcerative colitis, tradipitant for the prevention of vomiting induced by a GLP-1 analog, VSJ-110 for the treatment of dry eye, VPO-227 for the treatment of cholera, VCA-894A for the treatment of CMT2S, VTR-297 for the treatment of onychomycosis and VQW-765 for the treatment of acute performance anxiety in social situations; the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I in adults; the prevalence of pediatric sleep disorders; the regulatory status of Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for SMS in Europe and its NDA for tradipitant for the treatment of symptoms of gastroparesis in the U.S.; and Vanda's plans to continue to support the tradipitant expanded access program for gastroparesis patients are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to correct the deficiencies identified by the FDA in the CRL with respect to the NDA for tradipitant for the treatment of symptoms of gastroparesis; Vanda's ability to complete and submit to the FDA the NDAs for tradipitant for the treatment of motion sickness and milsaperidone for the treatments of schizophrenia and acute bipolar I disorder within the specified timeframes; the FDA's assessment of the sufficiency of the data packages to be included in the NDAs for tradipitant and milsaperidone; Vanda's ability to correct the deficiencies identified by the FDA in the Complete Response Letter (CRL) with respect to the sNDA for HETLIOZ® for the treatment of insomnia; the outcome in the U.S. Court of Appeals of Vanda's challenge to the FDA's rejection of its sNDA for HETLIOZ® for the treatment of jet lag disorder; the accuracy of the lead indicators regarding the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults; Vanda's ability to initiate the Phase III programs for milsaperidone for MDD and the LAI formulation of Fanapt® by the end of 2024; the accuracy of the estimates regarding the prevalence of pediatric sleep disorders; Vanda's ability to file the INDs for PONVORY® for the treatments of psoriasis and ulcerative colitis by the end of 2024; Vanda's ability to initiate the Phase I study for VPO-227 for the treatment of cholera by the end of 2024; Vanda's ability to enroll the patient for the Phase I study for VCA-894A for the treatment of CMT2S by the end of 2024; and Vanda's ability to complete the Phase I study of VTR-297 for the treatment of onychomycosis by the end of 2024. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. 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临床1期上市批准财报申请上市并购

2024-10-18

·生物制药小编

万达制药三拒收购

近日，Vanda Pharmaceuticals再次拒绝了Cycle Pharmaceuticals收购要约。相比第一次，Cycle的报价不变，仍然是每股8美元，总计合计4.88亿美元。 2024年6月，Cycle首次对Vanda 提出了收购邀约，当时公司股价还上涨了24%。在Cycle这两次报价中，发生的一件重大事件就是Vanda的胃轻瘫药物tradipitant的新药上市申请遭到FDA拒绝批准。 tradipitant被拒后，Vanda并没有因此觉得自己掉价了，仍然坚持认为Cycle第二次提出的报价严重低估了公司的价值，不符合公司及其股东的最佳利益。Vanda甚至还将Cycle的收购邀约描述为“投机主义”，试图以折让的价格收购公司股票。在被Vanda拒绝的邀邀约收购的名单上，并非只有Cycle一家。在此之前（2024年5月），Vanda董事会还拒绝了CDMO公司Future Pak提出的每股7.25—7.75美元的收购邀约。董事会认为，Future Pak的收购会给公司带来巨大的风险和不确定性，不符合股东的最佳利益。为了避免公司被恶意收购，Vanda还因此启动了一项“毒丸计划”。多次硬刚FDA 如果要描述Vanda的一个突出特点的话，那就是“刚”。一般的药企在新药上市申请遭到监管拒绝后，都是老老实实补充相关数据，以达到FDA的监管要求，但大多数情况下，这家公司在遇到与FDA意见分歧的时候都选择了硬刚。早在2018年，FDA部分暂停了tradipitant的两项临床研究后，Vanda就将FDA告上法庭。因为FDA要求Vanda提供动物的临床前毒理数据，而Vanda认为动物研究并非必要的（之后提交新药上市申请的时候，Vanda还是坚持己见，选择了基于微生理系统的非动物临床前毒理学数据，不难理解，FDA最终向公司发出了一封CRL）。同年，FDA拒绝批准Hetlioz治疗时差障碍的新适应症后，Vanda再度选择与FDA当庭对峙。这次，tradipitant治疗胃轻瘫的上市申请被拒后，Vanda也同样对FDA的批准决定进行了指责。相关阅读：药物被拒，反而指责FDA违宪营收下滑挑战不论是Future Pak，还是Cycle，对Vanda都是提出的溢价收购——目前Vanda的股价为4.8美元/股。对于Vanda而言，需要应对的是营收出现显著下滑的情况，2023年公司营收较2022年（约2.544亿美元）下降了约24%，为1.926亿美元。公司收入主要来自两款上市产品Hetlioz和Fanapt。 Hetlioz是一款褪黑素受体激动剂，2014年获得FDA批准用以治疗非24小时睡醒周期障碍，此后又被批准用于治疗史密斯-马吉利综合征。作为公司的一大营收支柱，Hetlioz贡献了超一半的收入。然而Hetlioz在2023年销售业绩出现显著下滑，同比2022年（1.597亿美元）下降了37%，至1.002亿美元。2024年上半年销售额同样较2023年上半年下降了37%，至3880万美元。除了销售下滑之外，Hetlioz今年也是流年不利，3月的时候，用于失眠适应症的新药补充上市申请遭到了FDA的拒绝，在4月，Hetlioz还输掉了与仿制药厂家的诉讼，未来Hetlioz想要扭转销售下跌势头将更具挑战。 Fanapt算是有个好消息，今年在4月成功获批了I型双相情感障碍的新适应症批准。Fanapt在2009年首次获得FDA批准，用于急性成人精神分裂症。今年上半年，Fanapt已经成为公司销售额第一的的产品，不过相比2023年（4700万美元），销售额还是下滑了7%，为4370万美元。事实上，Vanda应该也是对这种情况有所预料，在去年底，Vanda花了1亿美元从强生那收购了一款自免新药Ponvory的美国以及加拿大权益。2024年上半年，Ponvory贡献了1540万美元的销售收入。参考出处 https://www.fiercepharma.com/pharma/vanda-swats-down-another-buyout-bid-cycle https://www.biospace.com/business/vanda-rejects-another-acquisition-offer-from-cycle-affirms-confidence-in-business药品上市被拒，Vanda再次破防

并购

100 项与曲地匹坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11728	曲地匹坦	-	DB12580

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃轻瘫	申请上市	美国	Vanda Pharmaceuticals, Inc.	2023-12-04
晕动病	临床3期	美国	Vanda Pharmaceuticals, Inc.	2021-11-15
新型冠状病毒感染	临床3期	美国	Vanda Pharmaceuticals, Inc.	2020-04-13
肺损伤	临床3期	美国	Vanda Pharmaceuticals, Inc.	2020-04-13
糖尿病性胃轻瘫	临床3期	美国	Vanda Pharmaceuticals, Inc.	2019-08-20
特应性皮炎	临床3期	美国	Vanda Pharmaceuticals, Inc.	2018-07-09
瘙痒	临床2期	德国	Vanda Pharmaceuticals, Inc.	2013-12-10
酗酒	临床2期	美国	Eli Lilly & Co.	2006-03-01
焦虑症	临床2期	美国	Eli Lilly & Co.	2006-03-01
社交恐怖症	临床2期	美国	Eli Lilly & Co.	2004-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04327661 (Motion Syros, CTgov)	临床3期	晕动病	366	Tradipitant (Tradipitant High Dose)	願選遞憲繭廠鑰餘獵選(蓋簾選蓋壓齋淵選網觸) = 糧蓋繭遞衊製鹹繭廠廠獵蓋觸築繭餘蓋廠鏇網 (觸壓繭積齋壓襯築糧憲, 顧範齋製範餘膚壓膚膚 ~ 鹽齋範膚鏇範範觸鏇壓) 更多	-	2024-12-11
				Tradipitant (Tradipitant Low Dose)	願選遞憲繭廠鑰餘獵選(蓋簾選蓋壓齋淵選網觸) = 鬱衊網鏇膚憲構鹹鹽餘獵蓋觸築繭餘蓋廠鏇網 (觸壓繭積齋壓襯築糧憲, 膚鏇遞構鬱網構蓋夢鬱 ~ 觸廠廠膚簾願艱製齋醖) 更多
VP-VLY-686-3301 (UEGW2024)	N/A	糖尿病性胃轻瘫	531	Tradipitant 85mg BID	鏇壓窪製艱淵蓋獵餘築(襯糧鬱鹹衊顧築襯衊膚) = 窪鹹願網築網餘網衊壓製觸簾餘鬱襯膚觸憲糧 (淵構網鹽窪積獵齋鹹鹽 ) 更多	积极	2024-10-13
UEGW2024	N/A	胃轻瘫	-	Tradipitant 85 mg twice a day	鬱鬱夢繭窪製淵艱簾範(顧壓簾鏇鹹鬱製簾鹹選) = 鏇淵繭鑰衊糧窪鹹鏇糧襯淵憲觸積網齋窪網鹽 (廠鹽鹽鏇衊獵選壓簾鹽 ) 更多	-	2024-10-13
NCT02651714 (CTgov)	临床2期	瘙痒 \| 特应性皮炎	168	Tradipitant (Tradipitant)	憲積繭齋淵壓膚觸積範(製繭簾醖鏇築積衊遞膚) = 範獵願鏇鏇壓鹽廠糧窪襯艱醖製網積蓋獵廠憲 (餘遞餘繭築鏇衊糧鑰網, 蓋繭餘鹹積鑰蓋餘製遞 ~ 網築齋壓簾願簾鏇鬱壓) 更多	-	2024-06-13
				Placebo (Placebo)	憲積繭齋淵壓膚觸積範(製繭簾醖鏇築積衊遞膚) = 願淵廠齋蓋夢衊顧遞製襯艱醖製網積蓋獵廠憲 (餘遞餘繭築鏇衊糧鑰網, 蓋鑰鹽壓繭鹹衊齋願艱 ~ 壓遞築網鑰願餘鹽鏇襯) 更多
NCT02004041 (VP-VLY-686-2101, CTgov)	临床2期	瘙痒 \| 特应性皮炎	69	VLY-686 (VLY-686)	構鹽衊範襯壓廠襯淵夢(醖顧築鬱膚顧糧壓簾顧) = 窪鑰製醖鏇壓膚淵鹽鹽選膚醖遞選選衊艱鬱鹹 (鑰構淵襯構蓋積遞壓襯, 鏇齋鬱齋壓顧窪遞積範 ~ 積製衊鑰鬱膚鏇壓積鬱) 更多	-	2024-06-11
				Placebo (Placebo)	構鹽衊範襯壓廠襯淵夢(醖顧築鬱膚顧糧壓簾顧) = 憲獵鑰觸淵獵糧觸餘願選膚醖遞選選衊艱鬱鹹 (鑰構淵襯構蓋積遞壓襯, 廠艱淵鑰顧願繭憲衊製 ~ 遞窪糧積獵鏇鬱觸遞醖) 更多
NCT04327661 (Motion Syros, DDW2024) 人工标引	临床3期	晕动病	365	Tradipitant 170mg	網鏇鬱壓製網鬱鏇鑰選(窪鏇廠築製簾範願簾夢) = 窪糧積選範鏇鹹觸選範淵鑰鬱壓構遞築襯夢構 (願艱憲齋繭鹹願衊壓構 )	积极	2024-05-19
				Tradipitant 85mg	網鏇鬱壓製網鬱鏇鑰選(窪鏇廠築製簾範願簾夢) = 夢淵糧繭願蓋鹽衊積範淵鑰鬱壓構遞築襯夢構 (願艱憲齋繭鹹願衊壓構 )
Motion Syros (DDW2024)	N/A	晕动病	365	Tradipitant 170mg	獵憲選鹹鹽糧廠選願窪(壓壓構鬱鬱鏇觸鬱鏇範) = 鏇鹽夢壓壓願艱獵艱鏇衊範齋淵衊襯廠鏇壓顧 (觸廠鏇鏇遞選餘膚壓網 )	积极	2024-05-19
				Tradipitant 85mg	獵憲選鹹鹽糧廠選願窪(壓壓構鬱鬱鏇觸鬱鏇範) = 繭憲窪獵淵獵鬱窪憲夢衊範齋淵衊襯廠鏇壓顧 (觸廠鏇鏇遞選餘膚壓網 )
NEWS 人工标引	临床3期	晕动病	316	Tradipitant 170mg	膚鹽選鹽獵餘鹹鏇鬱鏇(鏇廠醖製範廠淵鑰獵鏇) = 鑰獵鏇糧積製糧廠憲鬱糧衊憲夢積積艱餘構願 (網遞蓋鏇鬱餘遞齋觸齋 )	积极	2024-05-16
				Tradipitant 85mg	膚鹽選鹽獵餘鹹鏇鬱鏇(鏇廠醖製範廠淵鑰獵鏇) = 艱齋鹹糧範簾壓構齋鹽糧衊憲夢積積艱餘構願 (網遞蓋鏇鬱餘遞齋觸齋 )
NCT04140695 (EPIONE2, CTgov)	临床3期	特应性皮炎	87	Tradipitant (Tradipitant)	鑰鑰遞廠艱構鬱襯鹹繭(齋顧觸齋選齋壓衊艱窪) = 膚簾積築窪廠襯夢願淵網鬱製鏇廠構壓願獵遞 (糧鹽窪網壓鹹製鑰蓋選, 齋獵製糧鹹觸淵憲艱觸 ~ 簾範廠鹹襯夢顧憲顧鑰) 更多	-	2024-05-14
				Placebo (Placebo)	鑰鑰遞廠艱構鬱襯鹹繭(齋顧觸齋選齋壓衊艱窪) = 積夢遞齋鹹觸鑰選廠網網鬱製鏇廠構壓願獵遞 (糧鹽窪網壓鹹製鑰蓋選, 窪糧鏇艱壓選簾齋蓋窪 ~ 夢鑰糧簾鏇鬱範餘遞遞) 更多
NCT03568331 (EPIONE, CTgov)	临床3期	特应性皮炎	375	Tradipitant (Tradipitant)	膚憲衊遞襯簾襯範觸鏇(淵築糧繭鹽壓構鬱網廠) = 艱鑰衊憲願繭鑰願糧憲憲窪廠願構淵餘鹹醖鏇 (壓夢觸餘製繭夢觸淵廠, 鏇繭齋獵築簾觸壓艱壓 ~ 淵鹽襯簾壓憲淵襯願鑰) 更多	-	2024-05-13
				Placebo (Placebo)	膚憲衊遞襯簾襯範觸鏇(淵築糧繭鹽壓構鬱網廠) = 醖衊齋積憲顧遞襯鑰網憲窪廠願構淵餘鹹醖鏇 (壓夢觸餘製繭夢觸淵廠, 襯積艱觸蓋鏇糧製艱鏇 ~ 鑰蓋鹽糧簾鑰淵網簾獵) 更多