Apremilast

-Topline readout expected in early Q1 2026- SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,” said Martin Babler, President and Chief Executive Officer of Alumis. “With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need." “As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options," said Dr. Jörn Drappa, Alumis’ Chief Medical Officer. "Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment." The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001’s potential application in other immune-mediated conditions. About Alumis Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis’ topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis’ future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis’ ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, Alumis’ ability to protect its intellectual property and other risks and uncertainties described in Alumis’ filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Alumis Contact Information Teri Dahlman Red House Communications teri@redhousecomms.com

5月20日，CDE官网显示百时美施贵宝（BMS）的氘可来昔替尼片（商品名：颂狄多®）新适应症上市申请获受理。结合临床试验进展推测，业内普遍推测此次申报的适应症为银屑病关节炎。作为全球首个获批的口服选择性酪氨酸激酶2（TYK2）变构抑制剂，氘可来昔替尼早前于2023年10月在中国获批用于中重度斑块状银屑病。图源：CDE官网氘可来昔替尼不同于传统JAK抑制剂通过竞争ATP结合位点发挥作用，它选择性与TYK2的调节结构域（JH2）结合，通过变构效应抑制其活化，从而精准阻断IL-23、IL-12和I型干扰素等核心炎症信号通路。这种机制不仅提高了靶点选择性，还避免了因抑制JAK1/2/3导致的广泛免疫抑制，为患者提供了更安全的长期用药选择。银屑病关节炎(PsA)是一种兼具关节炎症和皮肤表现的异质性疾病，传统治疗药物如TNF抑制剂虽有效，但部分患者应答不足或出现耐药，且存在感染风险升高的问题。氘可来昔替尼通过靶向TYK2这一IL-23/Th17轴的关键节点，既能控制关节炎症，又能同步改善皮肤症状，实现了“双管齐下”的治疗效果。此外，其对头皮、掌跖等难治部位皮损的显著改善进一步巩固了其在复杂病例中的治疗地位。在针对银屑病关节炎的III期试验POETYKPsA-2中，治疗16周时，氘可来昔替尼组患者的ACR20 （疾病体征和症状至少改善20%）应答率达54.2%，显著优于安慰剂组的39.4%（p=0.0002），同时PASI75（银屑病面积和严重程度指数改善至少75%）应答率也明显提升。该药不仅在关节症状控制上表现优异，还显著改善了患者生活质量指标如HAQ-DI，较安慰剂组有更显著的基线改善（−0.32vs.−0.21，p=0.0013）。安全性上，III期试验中氘可来昔替尼组因不良事件停药率仅为2.2%，远低于参照组阿普米司特的10.5%，其选择性抑制TYK2而非JAK家族的特性显著降低了传统JAK抑制剂常见的感染、血液学异常等风险。在当前银屑病关节炎治疗市场中，生物制剂如TNF-α抑制剂、IL-17/23抑制剂占据主导地位，而口服药如JAK抑制剂、PDE4抑制剂则以便捷性吸引部分患者。氘可来昔替尼则兼具口服便捷性和安全性优势。相比需注射的生物制剂，氘可来昔替尼每日一次口服给药极大提升了患者依从性。对于许多对注射恐惧或需长期管理的患者而言，口服药的便利性无疑是巨大的吸引力。此外，该药无需冷藏保存，便于携带，进一步提高了患者的用药体验。与同为口服药的JAK抑制剂相比，氘可来昔替尼的选择性TYK2抑制机制避免了JAK家族广泛抑制带来的潜在风险。传统JAK抑制剂如托法替尼、乌帕替尼等虽能有效控制病情，但可能增加感染、心血管事件、血栓等风险。而氘可来昔替尼在治疗剂量下不抑制JAK1、JAK2或JAK3，从而显著降低了这些风险。尽管优势明显，但氘可来昔替尼仍面临市场竞争压力。生物制剂如司库奇尤单抗（IL-17A抑制剂）凭借高应答率（ACR50可达51%）占据一线治疗地位，而JAK抑制剂乌帕替尼虽安全性争议较大，但其在PsA适应症上的先发优势不可忽视。此外，仿制药的冲击也可能影响原研药的市场份额，老挝、孟加拉等国已上市氘可来昔替尼仿制药，价格仅为原研药的十分之一，尽管国内患者获取存在法律和渠道障碍，但跨境购药需求可能分流部分市场。氘可来昔替尼的研发管线显示，其正在拓展系统性红斑狼疮、干燥综合征等适应症的III期临床试验。若这些适应症获批，将极大拓宽其市场空间。此外，作为口服靶向药，其与生物制剂的联合应用潜力也值得关注，与IL-23抑制剂联用可能通过双重阻断炎症通路增强疗效，或与低剂量生物制剂联用以减少后者用量并降低副作用风险。未来，仿制药的冲击可能影响原研药的市场份额。目前老挝、孟加拉等国已上市氘可来昔替尼仿制药，价格仅为原研药的十分之一，尽管国内患者获取仿制药存在法律和渠道障碍，但跨境购药需求可能分流部分市场，原研厂商需通过持续创新和医保谈判巩固优势。氘可来昔替尼在银屑病关节炎领域的申报进展，不仅是BMS在免疫赛道的重要布局，也为患者提供了更安全、便捷的治疗选择。后续，如何在生物制剂主导的市场中突围，如何平衡原研药与仿制药的竞争，仍需企业通过真实世界疗效验证、差异化推广策略及灵活定价机制应对。参考来源：[1]CDE官网[2]https://news.pharmnet.com.cn/news/2025/03/11/600775.html药事纵横投稿须知：稿费已上调，欢迎投稿