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The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive, and will correlate mucosal healing with MAP2 infection eradication utilizing novel endpoints and imaging, pending Type C discussions on path to FDA approval, with FDA guidance expected in Q2/25 -- Patent protected until 2041, RHB-204 is a next generation anti-MAP therapy derivative of RHB-1043 which successfully met its groundbreaking Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus SoC and showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes -- Based on insights from RHB-104's statistically significant positive Phase 3 study results, the improved formulation RHB-204 is designed to reduce pill burden and further enhance tolerability, safety and adherence, and along with the uniquely defined patient population (MAP-positive), allows for a study design with a small sample size and decisive endpoints, entailing lower study costs and expedited timeframe -- The role of MAP as a cause of CD, to be tested in this study, supports a paradigm-shifting new therapeutic approach for CD – focused on addressing the actual cause of the disease, not the symptoms -- The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033, presenting significant commercial potential for a new FDA approved therapy RALEIGH, N.C. and TEL-AVIV, Israel, March 12, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD, utilizing novel endpoints and the new gold standard in imaging techniques, pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter. Patent protected until 2041, and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104), RHB-204, is a novel next generation improved formulation of Phase 3-stage RHB-104, designed to support enhanced tolerability, safety and adherence, with a 40% pill burden reduction, and thus potential better outcomes. In its groundbreaking positive Phase 3 study which met primary and secondary endpoints, RHB-104 demonstrated a 64% increase in efficacy versus SoC, superior remission as early as week 16, improving further at week 26 and continuing through week 52, and also showed compelling mucosal healing data in those patients who underwent colonoscopy. The Phase 2 study is expected to have primary endpoints of mucosal healing (considered a new gold standard in efficacy evaluation in Crohn's disease), MAP status and clinical remission, per FDA guidance following the positive Phase 3 CD study results with RHB-104. The RHB-204 study will be the first ever clinical trial in CD patients who are all MAP-positive, and will correlate mucosal healing with MAP eradication. Based on the successful RHB-104 Phase 3 study insights and specified endpoints, it is expected that the RHB-204 study could be efficiently conducted with a clearly defined and relatively small patient population, precise and decisive endpoints, and an expedited timeframe (with early efficacy indications potentially at just 16 weeks), reducing substantially the anticipated program costs. Clinical study material has already been manufactured and is in place ready for study implementation. The CD market is expected to expand significantly over the 2024–2033 forecast period, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%4. With significant numbers of treatment failures and approximately 1.6 million diagnosed prevalent cases of CD diagnosed globally last year4, there is a strong need for effective new CD therapies. Where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers, where applicable. Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine, said: "Up to 40% of patients fail to respond to anti-TNF treatment, and over time up to 50% of responders lose response and have disease flare-ups. In addition to the unmet medical need for alternative therapeutic approaches, most of the existing drugs for CD are both expensive and are intravenously administered, further adding to the treatment cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings, so we believe a safe and effective orally administered therapy would be a very convenient and welcome addition. Based on the safety and efficacy data with concomitant anti-TNFs, immunomodulators and steroids demonstrated in RedHill's initial RHB-104 Phase 3 U.S. study, the development of RHB-204 may provide an expedited route to a safe, oral, stand-alone or combination therapy." "Advances in diagnostic technology have led to increasingly higher identification of MAP in Crohn's diseases patients5," said Gilead Raday, Chief Operating Officer and Head of R&D at RedHill. "Utilizing gold standard imaging technology to provide clear and unambiguous efficacy results, the study is designed to include only MAP positive CD patients and is expected to increase the study's power, potentially allowing to demonstrate the benefits of RHB-204 anti-MAP therapy in a relatively small sample size, over and above the promising efficacy observed in the positive Phase 3 study results of RHB-104's in all-comer CD patients. RedHill is actively pursuing partnering and collaborations for this program, including ongoing discussions with non-dilutive external funding sources, which may pave the way to a much-needed new therapeutic modality for CD, focused on addressing a suspected cause of the disease, as opposed to just its symptoms." The randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active Crohn's disease met its primary and secondary endpoints, showing RHB-104 standard of care (SoC) to be 64% more effective than SoC alone, was published in the peer-reviewed journal, Antibiotics6. In the global study, conducted across 92 sites, a total of 166 patients were randomized to receive RHB-104 plus SoC and 165 to placebo plus SoC. Data for the primary endpoint, clinical remission at week 26, shows, with high statistical significance, that 36.7% (61/166) of RHB-104 patients achieved clinical remission at week 26 vs. 22.4% (37/165) of placebo patients (p = 0.0048). In the secondary endpoint of mucosal healing, endoscopy was performed in a group of 35 patients who volunteered to undergo colonoscopy, with results showing meaningful improvement in endoscopic healing (Simple Endoscopic Score for Crohn's Disease (SES-CD)) at week 26 (statistically significant at 25% decrease with similar trend at 50% decrease), despite the small sample size. Further corroborating these results was the statistically significantly marked and continuous decline of inflammatory marker, fecal calprotectin (FCP) - an accepted surrogate for mucosal healing - in the RHB-104 active arm from baseline through week 52 in patients with high calprotectin at baseline. RHB-104 was found to be generally safe and well tolerated, with adverse event reporting similar to placebo. Full results are available in the publication. About Crohn's Disease: Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. There is no known cure for Crohn's disease. According to the Cleveland Clinic, experts estimate that more than three-quarters of a million Americans and approximately 6-8 million people globally have Crohn's disease Commonly used FDA approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib). About RHB-204 RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat MAP+-related Crohn's disease. Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Originally developed for the treatment of pulmonary NTM disease caused by MAC, RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RedHill has protection for RHB-204, and its use in treating pulmonary MAC disease, until 2041. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults7. RedHill's key clinical late-stage development programs include: (i) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iii) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential development of RHB-204 for Crohn's disease. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the development of RHB-204 for Crohn's disease may not be completed and if completed may not be successful; the risk that the Company will not benefit from its agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: R&D 1 RHB-204 is an investigational new drug, not available for commercial distribution in the United States. 2 Mycobacterium avium subspecies paratuberculosis 3 RHB-104 is an investigational new drug, not available for commercial distribution in the United States. 4 DataMonitor - Disease Analysis: Crohn's Disease, September 2024 5 Bull, J Clin Microbiol, 2003 and Shafran, Dig Dis Sci, 2002 6 Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828. 7 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd. 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作者 | 凯西 颜色 编辑 | 遥望 北大医药再次迎来高管变动，上任一年左右的董事长齐子鑫宣布辞职。 01 北大医药董事长辞职 此前业绩有所回温 3月4日，北大医药发布公告称，董事长齐子鑫因个人原因辞去董事、董事长职务，同时辞去董事会战略委员会主任委员、提名委员会委员、薪酬与考核委员会委员职务，且不再担任北大医药任何职务。 北大医药前身为西南合成制药股份有限公司，作为一家成立于1993年，1997年就在深交所上市的老牌药企，齐子鑫的辞职引发了市场对北大医药未来走向的猜测。 其实齐子鑫的辞职并非毫无征兆，今年1月，齐子鑫辞去方正控股执行董事一职，自称是希望投入更多时间用于方正信息产业的工作。 2025年以来，北大医药的监事徐伟钰、董事任甄华、董事张勇先后辞职。 齐子鑫自2024年2月29日接任北大医药董事长以来，仅任职一年左右。因恪守职责，推动北大医药高质量发展，齐子鑫的贡献受到肯定。 2024年前三季度，北大医药实现净利润1.3亿元，同比增长182.49%，创历史新高。 2024年上半年业绩上升，北大医药将其归因于两方面： 一是医药工业板块继续聚焦“抗感染类、镇痛类、精神类”领域，重点市场拓展成效显著，重点产品（注射用美罗培南、盐酸丁螺环酮片、注射用头孢噻肟钠、盐酸昂丹司琼片等）销量提升及降本增效带动盈利能力同比提升；二是医药流通板块，受益于其产业下游需求业务量的逐步增长，全资子公司北京北医医药的业务收入规模同比提升，故净利润同比有所增长。 北京北医医药，主要为北京大学国际医院提供医疗设备、药品、耗材等供应链服务。根据2022、2023年年报，在北大医药的营收构成中，药品流通占比超过60%。 然而北医医药与国际医院的合同将于2025年到期，在北大医药此前披露的公告中，这将使得其自2025年起可能面临年销售收入减少约9.10亿元，净利润损失约3666万元的风险。 此外，业绩暂时回温之下，北大医药的仿制药业务仍然面临调整。 2022年，北大医药实现营业收入20.77亿元，较去年同期下滑7.13%，北大医药称营业收入的下降主要受到带量采购、医保目录谈判等行业政策实施影响，好在通过降本增效，当年北大医药实现归母净利润5598.19万元，较上一年同期增长29.76%。 在2022年的年度报告中，北大医药称公司内部面临诸多挑战——重点品种头孢曲松钠受集采影响，销量价格大幅波动，大股东重整导致历史遗留的风险问题不断困扰公司的稳定发展。  注射用头孢曲松钠为第五批国采品种，米内网数据显示，2021年在中国公立医疗机构终端的销售额超过37亿元，2022年受国采执行影响下滑接近50%，2023及2024上半年有所回升。 02 失去“北大”名号 北大医药如何发展？ 在2024年末，北大医药发布公告称，控股股东上层股权结构发生变动、实际控制人发生变更，“平安系”撤退。 新优势国际以1元的价格收购合成集团100%股权，同时支付3300万元，购买新方正控股和方正数码对合成集团及其下属公司的债权，完成“股权转让+债权转让”的捆绑式交易。 之后新优势国际成为北大医药第一大股东的控股股东，徐晰人成为北大医药实际控制人。 2009年起，北大医药的前身名称逐步变更，最终于2013年11月更名为“北大医药股份有限公司”，成为北大方正集团旗下核心医药资产平台。 此次北大医药的易主还伴随着公司名称的变更。交易完成后，北大医药将不得含有“北大”“北大医药”“北医”等字样，北大两字的明星光环可能不在。 3月1日，北大医药发布《第十一届董事会第六次会议决议公告》 ，提名徐晰人、杨力今为第十一届董事会非独立董事候选人。 在宣布控股股东上层股权结构发生变动、实际控制人发生变更后，今年2月，北大医药发布《关于控股股东上层股权结构调整的公告》。 控股股东上层股权结构调整后，北大医药股权控制关系如下： 作为一家老牌药企，北大医药的主要业务包括制剂研发、生产、销售及医药流通等，将“北大”融入其企业名称，一度对企业的品牌推广以及人才招揽助力不小。 失去“北大”字号后，新品牌的建立需要时间。 赛柏蓝注意到，北大医药近期发布公告称，出于促进公司产业链的发展，整合产业上下游资源，拓展国际化发展空间等目的，拟设立新的全资子公司——新优势（重庆）健康产业发展有限公司（暂定名），注册资本拟为3,000万元人民币（含）以内，经营范围包括药品生产、销售，普通货运、危险货物运输生产输液用袋、投资管理等。 从实控人生变到董事长离职，北大医药内部变动频繁，后续的资本故事将如何续写？ END 内容沟通：郑瑶（13810174402） 左下角「关注账号」，右下角「在看」，防止失联