Lorcaserin Hydrochloride

Graham Heap, MD, PhD, formerly Vice President and Program Leader for Takeda's global TYK2 immunology franchise, appointed President, Research and Development Also appointed: Ezequiel Neimark, MD, Head of Clinical Development; Taylor Spector, PhD, Head of Medical Affairs; Scott Stirn, DSc, Head of CMC cAMPfield Therapeutics is advancing prifemilast, a once-daily oral PDE4 inhibitor, for the treatment of inflammatory bowel disease (IBD) into global Phase 2 trials in moderate-to-severe ulcerative colitis and Crohn's disease SAN DIEGO, Aug. 3, 2026 /PRNewswire/ -- cAMPfield Therapeutics, Inc. (cAMPfield), a clinical-stage biopharmaceutical company formed to develop well-tolerated and highly effective oral medicines for immune-mediated inflammatory diseases, today announced key executive appointments to its senior leadership team. Continue Reading Graham Heap Graham Heap, MD, PhD joins as President, Research and Development (R&D), with responsibility for leading all the Company's research and development activities. Ezequiel Neimark, MD joins as Head of Clinical Development and will lead clinical execution for the prifemilast program in ulcerative colitis (UC) and Crohn's disease (CD). Taylor Spector, PhD joins as Head of Medical Affairs and will lead medical strategy, evidence generation, scientific communications, and external engagement. Scott Stirn, DSc joins as Head of Chemistry, Manufacturing, and Controls (CMC) and will lead drug substance and drug product development, manufacturing scale-up, analytical development, and clinical supply of prifemilast. These appointments deepen cAMPfield's leadership bench as the company advances prifemilast, a potentially best-in-class once-daily oral PDE4 inhibitor, into global Phase 2 trials in moderate-to-severe UC and CD. "Building a world-class leadership team with a proven track record of developing therapies for immune-mediated diseases is critical to our success," said Bill Gerhart, Chief Executive Officer of cAMPfield. "Graham, Ezequiel, Taylor, and Scott each bring deep expertise in inflammatory disease drug development and share our passionate belief that patients with IBD need better oral treatment options. Their considerable experience and leadership will be instrumental as we advance prifemilast through global Phase 2 development and position cAMPfield as a leader in IBD." "The treatment landscape for IBD continues to evolve, yet many patients still do not achieve durable disease control with existing therapies," said Dr. Heap. "I've long believed the potential of the PDE4 pathway has been underappreciated in IBD. Prifemilast combines a differentiated mechanism with encouraging clinical data, and I believe it can become an important new oral treatment option for patients with IBD. I look forward to working with the team to advance its development and to help build a broader pipeline beyond it." In addition to these appointments, cAMPfield's leadership team includes other accomplished executives building the company's technical, operational, clinical, and regulatory foundation. Patricia Turney, MBA, Chief Technical Officer, leads technical operations and manufacturing, bringing prior experience from Acelyrin, Arcutis, and Amgen. John Kempen, MS, Senior Vice President of Clinical Development Operations, oversees clinical execution for the prifemilast program, drawing on prior experience from Gossamer Bio, Receptos/Celgene, Ardea Biosciences/AstraZeneca, Allergan, PPD, and ICON. Rita Shah, PharmD, Vice President of Regulatory Affairs, directs the company's global regulatory strategy, leveraging prior experience from Vertex Pharmaceuticals, MBX Biosciences, AstraZeneca, and Johnson & Johnson. Biographies Graham Heap, MD, PhD – President, R&D A physician-scientist with an academic foundation in IBD and extensive development experience across gastroenterology, dermatology and rheumatology, Dr. Heap brings broad leadership expertise advancing therapies for immune-mediated diseases. Most recently, he served as Vice President and Program Leader for Takeda's global TYK2 immunology franchise, leading a large global cross-functional organization responsible for the strategy and execution of a late-stage development portfolio spanning six immune-mediated disease indications. He led zasocitinib from program integration through Phase 2 and Phase 3 readouts, including head-to-head trials against multiple comparators, while expanding the portfolio into five additional indications in Phase 2 or Phase 3 development. Prior to Takeda, Dr. Heap advanced multiple immunology and UC development programs at AbbVie, including risankizumab and ravagalimab. He earned his MBBS from St. George's, University of London and his PhD from Barts and The London School of Medicine and Dentistry. Ezequiel Neimark, MD – Vice President, Head of Clinical Development During more than a decade at AbbVie, Dr. Neimark held senior development leadership roles across gastroenterology, dermatology, and rheumatology and contributed to multiple pivotal IBD programs with adalimumab and risankizumab. He most recently served as Head of Asset/Indication for Skyrizi®, Humira®, ABBV-547, and ABBV-423, and is a physician-scientist trained in gastroenterology and hepatology. Taylor Spector, PhD – Executive Director, Head of Medical Affairs Dr. Spector brings nearly 15 years of Medical Affairs experience across all stages of the product lifecycle advancing programs in immune-mediated inflammatory diseases. Most recently she served as Global Medical Lead for Takeda's TYK2 program in Dermatology. Previously, she held Medical Affairs and Commercial leadership roles at Sobi, Alexion Pharmaceuticals, Sage Therapeutics, Amarin, and AstraZeneca. Scott Stirn, DSc – Executive Director, Head of CMC Dr. Stirn brings over two decades of experience advancing the product development and manufacturing of small molecules, peptides, and biologics from discovery through clinical development. Most recently, as Director and Head of Early Phase Product Development at Neurocrine Biosciences, he served as a global program and CMC lead across multiple small-molecule, peptide, and gene therapy programs, and contributed to the CMC regulatory filings supporting approved therapies including Ingrezza® (valbenazine) and Crenessity® (crinecerfont). Earlier in his career, he led formulation and product development efforts at Pharmatek, Celgene, and Arena Pharmaceuticals, spanning oral and injectable programs—including the development of lorcaserin (Belviq®) and S1P receptor modulator assets. About Inflammatory Bowel Disease Inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, is a chronic immune-mediated inflammatory disease that affects more than 2.4 million people in the United States and remains an area of substantial unmet medical need. Despite significant advances in treatment, many patients fail to achieve durable remission or lose response over time, resulting in frequent treatment switching. While biologic therapies have transformed outcomes for many patients, there remains a need for additional effective, well-tolerated treatment options. Convenient oral therapies are an important part of the treatment landscape, yet currently approved oral agents for IBD are limited by tolerability, safety concerns and/or modest efficacy. About Prifemilast Prifemilast is an investigational, once-daily, PDE4B-selective inhibitor that has been studied in more than 700 participants to date, including more than 250 participants treated for up to 52 weeks. Prifemilast preferentially inhibits PDE4B, the isoform most closely associated with anti-inflammatory activity, while minimizing inhibition of PDE4D, an isoform associated with dose-limiting adverse effects. Across clinical studies, prifemilast has been well tolerated, with treatment discontinuation rates comparable to placebo, and with demonstrated efficacy thus far in Phase 3 clinical trials in plaque psoriasis. About cAMPfield Therapeutics cAMPfield Therapeutics is a clinical-stage biopharmaceutical company focused on developing well-tolerated and highly effective oral medicines for immune-mediated inflammatory diseases, including inflammatory bowel disease. cAMPfield was founded by Mountainfield Venture Partners in partnership with executives who played key roles in the development and/or commercialization of Entyvio®, Humira®, Otezla®, and Zeposia®. cAMPfield holds exclusive global development and commercialization rights to prifemilast outside Greater China through a license agreement with Newsoara Biopharma Co., Ltd. The company is headquartered in San Diego, California. For more information, visit . Media and Investor Contact Rayne Rodgers [email protected] cAMPfield Therapeutics All third-party product names, company names, and logos are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them. 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本文要点 研究设计 口服介孔二氧化硅凝胶SiPore21在肠道内截留消化酶，12周多中心随机双盲安慰剂对照SHINE试验纳入318例超重或肥胖的糖尿病前期或早期2型糖尿病成人。 总体发现 SiPore21组的血糖、体成分和血脂指标均获改善，并伴随血糖状态稳定，为代谢疾病早期干预提供局部起效的非药物探索方向。 糖代谢效应 SiPore21使糖化血红蛋白较基线降低0.91 mmol/mol，但全人群组间差异受男性安慰剂反应影响，女性事后亚组分析中组间差异显著。 血糖转归 SiPore21组糖尿病前期进展为2型糖尿病的比例低于安慰剂组，并提高早期2型糖尿病逆转至糖尿病前期的比例，同时维持β细胞功能稳定。 代谢改善 SiPore21在不影响瘦体重的前提下，使体重和脂肪量分别降低1.14 kg和1.21 kg，并降低低密度脂蛋白胆固醇和总胆固醇。 安全性观察 不良事件以轻度、一过性胃肠道反应为主，未见严重器械相关不良事件，仍需开展更长期及更广泛人群研究评估其持续效应。 核心关键词 介孔二氧化硅颗粒　　SiPore21　　糖尿病前期　　早期2型糖尿病　　消化酶截留　　糖化血红蛋白　　体重管理 科普解读 在与肥胖和2型糖尿病（T2D）的漫长拉锯战中，全球正面临一个棘手的中转站——糖尿病前期。当血糖水平高于正常值但又未达到糖尿病诊断标准时，警报就已拉响。据统计，约25%的糖尿病前期人群会在3至5年内不可逆地滑向T2D，而目前主流的干预手段——生活方式干预，却因资源密集、患者长期依从性差等问题，在现实中往往力不从心。这一困境，正驱动着全球科学家寻找一种 安全且可规模化 的非药物策略。 一项于近期发表在EClinicalMedicine的随机、双盲、安慰剂对照的SHINE试验，为这一难题提供了一种 物理而非化学 的解决方案。由斯德哥尔摩大学温纳-格伦研究所的Tore Bengtsson团队主导的这项研究，验证了一种名为SiPore21的口服凝胶。它并非传统意义上的药物，而是一种搭载了 工程化介孔二氧化硅颗粒 的“机械装置”，其作用机制是在肠道内上演一场精密的“物理拦截”。 消化道里的“物理筛子” 要理解SiPore21为何能改善代谢，必须跳出传统药理的思维框架。该研究团队设计的二氧化硅微粒，其关键在于 定制的孔隙大小 。这些微米级的颗粒上布满了略大于消化酶（如淀粉酶、脂肪酶）但小于未消化食物的孔洞。当它随餐服用进入胃肠道后，便像一个 分子筛 ，通过物理空间将消化酶暂时“扣押”在孔道内，从而阻断了它们与食物大分子的接触。 这种局部的、物理的隔离，直接降低了碳水化合物和脂肪的分解效率， 减少了单餐的营养吸收 。尤其值得关注的是，这种“筛分”效应严格依赖于孔径大小，并非简单的非特异性吸附，这从根本上将SiPore21与市面上常见的膳食纤维或吸附剂区分开来，确保了其作用机制的 高度可控性 。 在女性中更显著的效果 这项为期12周的试验纳入了318名超重或肥胖且HbA1c（糖化血红蛋白）升高的糖尿病前期或早期T2D患者。核心数据显示，SiPore21组患者的HbA1c从基线水平 显著降低了0.91 mmol/mol ，而安慰剂组的下降（-0.60 mmol/mol）并未达到统计学意义。尽管组间总差异（p=0.5134）未达显著，但一项事后分析揭示了一个 性别特异性的信号 。 在女性参与者中，SiPore21展现出了明确的优势：与安慰剂相比，HbA1c的降幅达到了 统计学意义上的显著差异 （p = 0.019），而安慰剂组女性的HbA1c几乎纹丝不动。这种清晰的疗效对比，在男性中却因 强烈的安慰剂效应 而变得模糊。数据显示，安慰剂组男性也出现了显著的HbA1c下降，这可能与他们在试验期间无意中减少了酒精摄入、改善了肝功能酶（GGT、ALT等）水平有关。这一发现暗示，在排除了部分男性参与者可能存在的、自发改善生活方式的混杂因素后，SiPore21的物理控糖潜力在女性亚组中得到了更纯粹的体现。 体重与血脂的全面改善 除了血糖，SiPore21在体重和血脂管理上也交出了令人满意的答卷。与安慰剂相比，SiPore21组患者的体重 显著多下降了0.65公斤 （p = 0.0374），且这一减重主要源于 脂肪量的减少 ，瘦体重（去脂体重）得到了很好的保留。研究团队特别指出，即便是体重的微小下降，也能带来明确的代谢获益，而 每减重一公斤 都与延缓糖尿病进展、降低全因死亡风险相关。 在心血管代谢风险的另一个核心战场上，SiPore21同样带来了惊喜。其 低密度脂蛋白胆固醇（LDL-C） 水平较安慰剂组 显著降低 （p = 0.035）， 总胆固醇 也同步改善（p = 0.0496）。一项复合代谢风险评分显示，治疗组在整合了血糖、体重、血脂等9项指标后，其整体代谢改善幅度 显著优于安慰剂组 （p = 0.0075），这描绘出该疗法 多靶点、协同改善 的综合优势。 逆转疾病进程 更令人鼓舞的是，这项研究观察到了 疾病进程的逆转 。在基线已确诊T2D的参与者中，SiPore21组有 23.81%的患者在12周后恢复到了糖尿病前期状态 ，而安慰剂组的这一比例仅为11.76%（p = 0.0044）。同时，在初始为糖尿病前期的人群中，SiPore21组进展为T2D的比率（6.06%）也显著低于安慰剂组（10.29%）。这与其能够 稳定β细胞功能 （HOMA-B水平在治疗组保持稳定，而安慰剂组显著下降）的发现高度吻合，提示这种物理干预可能为岌岌可危的胰岛功能赢得宝贵的喘息时间。 安全性与未来 作为一种全程在肠道内局部作用、 不被全身吸收 的二氧化硅颗粒，其安全性是临床转化的基石。数据显示，SiPore21的耐受性极佳， 依从率高达96.4% ，不良事件主要为轻度、一过性的胃肠道反应（如腹泻、腹胀等），且未报告任何 严重的器械相关不良事件 。其成分本身属于美国FDA公认安全（GRAS）的合成无定形二氧化硅，进一步夯实了其安全基础。 当然，这项研究也存在局限性，12周的干预期尚无法评估长期疗效与安全性，且事后分析发现的部分性别差异仍需更大规模的前瞻性研究来确认。但总体而言，SiPore21以其独特的物理作用模式，为庞大的糖尿病前期人群提供了一条介于纯粹生活方式干预与药物之间的新路径。它或许无法替代二甲双胍等强力降糖药，但其 非系统性、物理性、多靶点 的特性，使其有望成为代谢健康管理中的一种安全、便捷的长期辅助工具。 图片摘要 相关文章推荐 01 Lancet · IF: 109 Lancet：氯卡色林可预防或缓解超重/肥胖患者的2型糖尿病 02 Diabetologia · IF: 10.4 低碳水化合物高蛋白饮食可更好地改善2型糖尿病患者的血糖水平 03 American Journal of Clinical Nutrition · IF: 7.1 国内团队：低GI饮食有助于控制血糖 04 The Lancet Diabetes and Endocrinology · IF: 36.3 Lancet子刊：2型糖尿病2线治疗PK，索玛鲁肽战胜卡格列净 05 American Journal of Clinical Nutrition · IF: 7.1 乳制品及其脂肪含量会影响糖尿病患者的血糖和心血管风险吗？ 原文链接 https://rbase.chinagut.cn/base/article/d394db0f68be4a97b0f0538be79894d1