Camlipixant

VANCOUVER, British Columbia, March 27, 2024 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that it has closed on its agreement with Seyltx Inc. (“Seyltx”), a privately owned U.S. based drug development company, for the acquisition of Algernon’s NP-120 (“Ifenprodil”) research program for the purchase price of USD $2M cash and a 20% common share equity position in Seyltx. The Company previously announced on November 22, 2003 that it had signed a Letter of Intent with Seyltx, to acquire Algernon’s Ifenprodil research program. Ifenprodil is an N-methyl-D-aspartate (“NMDA”) receptor antagonist specifically targeting the NMDA type subunit 2B (GluN2B), which prevents glutamate signaling. Ifenprodil is one of Algernon’s lead research programs and represents a novel first-in-class potential treatment for chronic cough. It is thought to interfere with central signalling in the brain, suppressing the urge to cough. “There are multiple converging lines of evidence that define GluN2B as the master regulator of the cough reflex in the deep brain, including human clinical data with the allosteric inhibitor Ifenprodil in the hardest to treat cough population, those with underlying idiopathic pulmonary fibrosis, illustrating dramatic reductions in cough counts. This human efficacy data is complemented by an extensive safety package that de-risks the final phases of clinical development,” said Dietrich A. Stephan, Ph.D. co-founder and CEO of Seyltx. “I have great respect for the Algernon team who have done an outstanding job at maturing the program to this point, and we look forward to completing the clinical development of this exciting agent for a common and debilitating condition.” Seyltx plans to initiate an Ifenprodil multi-center Phase 2b placebo-controlled chronic cough study in CY2024. Algernon’s clinical management team will be available to provide support, oversight, and management of the study. “We are very pleased to have closed this transaction with Seyltx,” said Christopher J. Moreau, Algernon’s Chief Executive Officer. “We believe that Ifenprodil, a first in class potential treatment for chronic cough could outperform all other drugs that have been clinically investigated to date. We look forward to working with Seyltx as they advance Ifenprodil into the Phase 2b clinical trial.” In connection with the transaction, Maxim Group LLC was paid a transaction advisory services fee pursuant to an agreement with Algernon whereby Maxim was retained to identify and evaluate potential M&A and strategic opportunities. Algernon’s Phase 2a Study Data Algernon’s decision to advance to a Phase 2b cough study was based on positive data previously reported from the Company’s proof of concept Phase 2a study of idiopathic pulmonary fibrosis (“IPF”) and chronic cough, where Ifenprodil showed a significant reduction in cough count. Patients with IPF are usually excluded from trials in refractory chronic cough (“RCC”), and cough in this population is regarded as extremely difficult to treat. Key Data: The geometric mean 24-hour cough counts were reduced by 32.0% at 4 weeks(p = 0.023) and 39.5% at 12 weeks (p = 0.001) compared to baselineThe geometric mean awake cough counts were reduced by 30.2% at 4 weeks(p = 0.038) and 37.4% at 12 weeks (p = 0.002) compared to baselineAlgernon previously announced on January 14, 2022, that it had received positive feedback from the U.S. Food and Drug Administration at its pre-Investigational New Drug (pre-IND) meeting for its investigation of Ifenprodil solely for the treatment of chronic cough. About Chronic Cough Chronic cough is defined as a cough lasting for more than eight weeks in duration and in the United States cough continues to be one of the most common reasons that adults consult medical doctors. Some cases of chronic cough are so debilitating that quality of life is severely impacted leading to depression, anxiety, urinary incontinence, dysphonia, sleep interruption, vomiting, and even rib fractures further adding to the decay in socio-familial dynamics. Chronic cough is believed to be the result of a hypersensitivity of the cough reflex within the neuronal circuitry that governs the urge to cough, wherein one or more aspects that regulate cough are over-active to stimulus, triggering a cough at abnormal levels. Trials of cough suppressants (“Antitussives”) have shown differences in response that may reflect differing pathological processes driving cough in different patients. Experimental Antitussives (like gefapixant and camlipixant) often only engage a single receptor, while the overall cough response is governed by multiple receptors triggered by a large variety of stimuli. A compound like Ifenprodil, acting centrally in the brain where all peripheral messages are sent and coordinated, may achieve a better outcome than what has been achieved by others in clinical trials. Chronic Cough Market According to Data Bridge Market Research analyses, the global chronic cough market was valued at USD $6.15B in 2021 and is projected to grow up to USD $11.38B by 2029. Merck & Co. obtained the rights to gefapixant, a P2X3 receptor antagonist, as the lead asset in the acquisition of Afferent Pharmaceuticals in 2016. At the time, gefapixant had interim data from a Phase 2b study in RCC. The deal was worth up to USD $1.25 billion. Bellus Health, which was advancing camlipixant, its own novel P2X3 receptor antagonist, closed a deal on June 16, 2023 with GSK plc which bought all the outstanding shares in Bellus for USD $14.75 per share in cash with a total deal value estimated at USD $2 billion, confirming the need for better therapies for chronic cough. About NP-120 (Ifenprodil) NP-120 selectively inhibits GluN2B receptors which diminish excitability of neurons and prevent the relaying of information along neuronal circuitry, including the cough reflex. NP-120 may also inhibit the neuroplastic enhancement of central and peripheral cough response neurons. About Seyltx Inc. Seyltx is a clinical-stage pharmaceutical company focused on addressing refractory chronic cough by modulating the master switch of the cough reflex in the brain. Refractory chronic cough is a common disorder estimated to affect between 4-5 million individuals in the United States alone, for which there exist no effective therapies. About Algernon Pharmaceuticals Inc. Algernon Pharmaceuticals is a Canadian clinical stage drug development company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals has active research programs for chronic kidney disease and is the parent company of a private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of DMT for stroke and traumatic brain injury. CONTACT INFORMATION Christopher J. MoreauCEOAlgernon Pharmaceuticals Inc.604.398.4175 ext 701info@algernonpharmaceuticals.com investors@algernonpharmaceuticals.com www.algernonpharmaceuticals.com Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

博华出品友情推荐上方扫码👆提前注册🎁免排队免费领票！距2024 HOTELEX上海展还有  4  天******友情推荐↑↑今日正文↓↓本周，有不少热点值得关注。首先是审评审批方面，多个药物获批临床以及一些药物获批，最值得一提的就是中国生物的利妥昔单抗生物类似药获批上市；其次是研发方面，多个药物启动关键临床以及不少药物研发进展取得好结果，比如，阿斯利康启动了ALXN1850的关键Ⅲ期临床等；再次是交易及投融资方面，这几天国内外发生了不少交易，阿斯利康24亿美元收购核药公司Fusion；最后是上市方面，荃信生物正式在港交所上市。本周盘点包括审评审批、研发、交易及投融资和上市四大板块，统计时间为3.18-3.22，包含23条信息。 审评审批NMPA上市批准1、3月22日，NMPA官网显示，中国生物上海生物制品研究所的利妥昔单抗注射液生物类似药获批上市，用于非霍奇金淋巴瘤（滤泡性非霍奇金淋巴瘤、CD20阳性弥漫大B细胞性非霍奇金淋巴瘤）、慢性淋巴瘤细胞白血病（CLL）的治疗。利妥昔单抗是一种抗CD20单抗，原研产品为罗氏的美罗华。申请2、3月22日，CDE官网显示，Albireo和益普生的odevixibat胶囊申报上市。Odevixibat是一种强效、非体循环回肠胆汁酸转运蛋白（IBAT）抑制剂，已被CDE纳入优先审评，用于治疗6个月或以上患者的进行性家族性肝内胆汁淤积症（PFIC）。2023年3月，益普生收购Albireo，获得该疗法。临床批准       3、3月18日，CDE官网显示，石药集团1类新药SYH2039片获批临床，拟用于治疗晚期恶性肿瘤。SYH2039正是一种高活性MAT2A抑制剂，可选择性杀伤MTAP缺失型肿瘤细胞，同时对正常细胞的影响较小。4、3月19日，CDE官网显示，信达生物的IBI130获批临床，拟开发用于不可切除的局部晚期或转移性实体瘤。IBI130是一款靶向TROP2的抗体偶联药物（ADC），拟开发用于治疗肿瘤。目前，该药已在全球范围内进入到Ⅰ期临床试验阶段。5、3月20日，CDE官网显示，贝达药业1类新药BPI-520105片获批临床，拟用于治疗携带EGFR突变的实体瘤患者。BPI-520105是一种新型强效、高选择性的针对多种EGFR突变的泛表皮生长因子受体（Pan-EGFR）抑制剂。临床前研究显示，BPI-520105能够高效抑制多种EGFR突变，包括EGFR常见及罕见的单突变、携带T790M和/或C797S的双突变和三突变等。6、3月21日，CDE官网显示，康朴生物的1类新药KPG-818胶囊获批临床，拟用于治疗系统性红斑狼疮（SLE）。KPG-818是康朴生物的新一代口服分子胶免疫调节药物，归属E3泛素连接酶复合物CRL4-CRBN调节剂，对靶点CRBN显示出极高的亲和力。优先审评7、3月18日，CDE官网显示，辉瑞的CD3/BCMA双抗Elranatamab（Elrexfio）拟纳入优先审评，用于治疗既往接受过至少三种治疗（含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤（R/RMM）成人患者。突破性疗法8、3月18日，CDE官网显示，特瑞思的1类治疗用生物制品注射用TRS005拟纳入突破性疗法，用于治疗至少经过2次标准治疗的复发或难治性CD20阳性弥漫大B细胞淋巴瘤（DLBCL）。该产品是首个申请突破性疗法的CD20ADC。FDA上市批准9、3月19日，FDA官网显示，武田的Ponatinib（Iclusig）补充新药申请（sNDA）获加速批准，联合化疗一线治疗新诊断费城染色体阳性急性淋巴细胞白血病（Ph+ALL）成年患者。Ponatinib是一款三代Bcr-abl激酶抑制剂，最早于2012年12月在美国上市。孤儿药资格10、3月18日，FDA官网显示，华昊中天的优替德隆口服胶囊（UTD2）获孤儿药资格，用于治疗胃癌。优替德隆为一种基于合成生物学技术成功研发上市的化疗新分子，其与紫杉类作用机制相似，已于2021年在中国获批上市，用于治疗既往接受过至少一种蒽环类或紫杉类药物化疗方案的复发或转移性乳腺癌患者。11、3月21日，FDA官网显示，睿健医药的NouvSight001获孤儿药资格，针对视网膜色素变性系列适应症。NouvSight001是睿健医药团队依托“AI+化学诱导”平台开发的诱导多能干细胞（iPSC）来源的眼科通用型细胞治疗产品。研发临床状态12、3月18日，药物临床试验登记与信息公示平台显示，和黄医药启动了索凡替尼联合卡瑞利珠单抗、白蛋白结合型紫杉醇、吉西他滨治疗转移性胰腺癌的Ⅱ/Ⅲ期临床研究。索凡替尼是和黄医药自主研发的一种新型口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。13、3月18日，药物临床试验登记与信息公示平台显示，阿斯利康启动了两项ALXN1850注射液的国际多中心（含中国）Ⅲ期临床研究，分别用于治疗2~12岁低磷酸酯酶症儿童受试者、≥12岁的青少年和成人低磷酸酯酶症受试者。ALXN1850（重组碱性磷酸酶）属于新一代组织非特异性碱性磷酸酶酶替代疗法（ERT）。14、3月18日，药物临床试验登记与信息公示平台显示，百利天恒启动了BL-B01D1的Ⅲ期临床，在既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的复发性或转移性食管鳞癌患者中对比BL-B01D1与医生选择的化疗方案（二线）。BL-B01D1（伦康依隆妥单抗）是一种基于双特异性拓扑异构酶抑制剂的ADC。15、3月18日，药物临床试验登记与信息公示平台显示，华东医药启动了HDM1005的临床。HDM1005是华东医药自主研发的1类新药，属于GLP-1R/GIPR双靶点长效多肽类激动剂，2023年12月首次申报临床，于2024年3月获批。16、3月22日，药物临床试验登记与信息公示平台显示，Bellus启动了一项国际多中心（含中国）Ⅲ期临床研究，以评估BLU-5937治疗难治性慢性咳嗽（包括不明原因的慢性咳嗽）的安全性和有效性。BLU-5937是一款选择性口服P2X3受体拮抗剂。2023年4月，GSK以总额约为20亿美元收购Bellus，获得该疗法。临床数据17、3月18日，微芯生物宣布，西格列他钠（双洛平）单药治疗非酒精性脂肪性肝炎（NASH）的Ⅱ期CGZ203临床试验达到首要疗效终点。西格列他钠属于过氧化物酶增殖体活化相关受体（PPAR）全激动剂，于2021年10月在国内获批用于运动饮食无法有效控制的2型糖尿病患者，该药物也是全球首个获批的PPAR全激动剂药物。18、3月19日，信达生物宣布，重组人血管内皮生长因子受体（VEGFR）-抗体-人补体受体1(CR1)融合蛋白Efdamrofuspalfa注射液（IBI302）在中国新生血管性年龄相关性黄斑变性（nAMD）受试者中开展的第二项Ⅱ期临床研究（高剂量）达到主要终点。19、3月21日，罗氏合作伙伴Chugai制药（中外制药）公布了萨特利珠单抗（Enspryng）治疗全身型重症肌无力（gMG）的Ⅲ期LUMINESCE结果。虽在其主要终点观察到具有统计学意义的数据，但结果没有达到对临床获益程度的预期。萨特利珠单抗是一种运用SMARTTM再循环技术开发的人源化IgG2单抗，靶向IL-6受体。交易及投融资20、3月18日，百奥泰生物宣布，已与Stein签署授权许可与商业化协议，将其在研生物类似药BAT2506（戈利木单抗）和BAT2606（美泊利珠单抗）在巴西以及其余拉丁美洲地区市场独占的产品商业化权益有偿许可给Stein。该协议首付款及里程碑款总金额最高至600万美元。21、3月19日，阿斯利康宣布，已与Fusion达成最终协议，将以每股21美元的价格收购Fusion所有流通股，预计总交易金额约24亿美元。Fusion核心产品为FPI-2265，这是一款用于转移性去势抵抗性前列腺癌（mCRPC）的新疗法，靶向前列腺特异性膜抗原（PSMA）。目前该产品正处于Ⅱ期临床开发阶段。22、3月22日，健康元宣布，已与拜耳就一项小分子抑制剂在中国的开发、商业化和生产的独家许可签署协议。本次合作涉及的产品是拜耳开发的一种针对慢性阻塞性肺疾病（COPD）的创新型口服药物，已在欧洲完成Ⅰ期临床试验。该小分子化合物通过抑制脯氨酰内肽酶（PREP）活性，有效阻止了COPD炎症介质的产生。上市23、3月20日，荃信生物在港交所正式上市。荃信生物创办于2015年，专注于开发治疗自身免疫性疾病及过敏性疾病的生物疗法，有两个核心产品—IL-17A抑制剂QX002N、抗IL-4Rα单抗QX005N，它们目前分别处于Ⅲ期和Ⅱ期临床研究阶段。【企业推荐】【智药研习社近期课程预告】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~