Gantenerumab

Biomed Industries, Inc. Presents Four Pivotal Studies at AAIC 2025 Highlighting Breakthrough Therapies for Alzheimer’s, Rett Syndrome, and Obesity NA-831 is the only drug to date that has halted Alzheimer’s disease progression. Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.” — Dr. Lloyd L. Tran, CEO of Biomed SAN JOSE, CA, UNITED STATES, August 4, 2025 / EINPresswire.com / -- Biomed Industries, Inc., a leading biopharmaceutical innovator developing transformative therapies for neurological and metabolic diseases, today announced the presentation of four major scientific papers at the Alzheimer’s Association International Conference (AAIC), held July 27–31, 2025, in Toronto, Canada. The presentations featured Biomed’s next-generation oral therapies for Alzheimer’s disease, Rett syndrome, and obesity, with a focus on novel combination strategies designed to enhance safety, efficacy, and accessibility. Featured AAIC 2025 Presentations: 1. The End of the Amyloid Era? Evidence for a Paradigm Shift in the Quest to Treat Alzheimer’s Disease 2. A Phase 3 Clinical Protocol of NA-831 Combined with Donanemab in Early Alzheimer’s Disease: A Placebo-Controlled, Double-Blind Study 3. Associations Between Alzheimer’s Disease and Rett Syndrome: Clinical Trials of NA-831 and NA-921 4. Neuro-Metabolic Link Between Alzheimer’s Disease and Obesity: Clinical Evaluation of NA-831 and NA-931 1. PRESENTATION: The End of the Amyloid Era? A Paradigm Shift in Alzheimer’s Research For over three decades, the “amyloid hypothesis” has dominated Alzheimer’s disease (AD) research, asserting that amyloid-β accumulation is a primary driver of neurodegeneration. Biomed’s comprehensive analysis of Phase 3 trial data from seven anti-amyloid drugs — including aducanumab, lecanemab, donanemab, gantenerumab, bapineuzumab, crenezumab, and solanezumab — challenges this paradigm. Across all trials, both treatment and placebo groups exhibited similar cognitive decline, as measured by CDR-SB and ADAS-Cog. The average differences between treatment and placebo arms were minor and not clinically significant (CDR-SB: -0.25; ADAS-Cog: -0.79). Slope comparisons further revealed near-identical rates of decline between groups. “Our analysis of Phase 3 clinical trial data for seven anti-amyloid drugs, including FDA-approved Aducanumab, Lecanemab, and Donanemab, indicates that none could halt disease progression in a clinically meaningful way — and all carried serious safety concerns,” said Dr. Zung Tran, VP of Biostatistics and AI at Biomed. 2. PRESENTATION: Phase 3 Clinical Protocol of NA-831 Combined with Donanemab NA-831, Biomed’s lead oral candidate, is a first-in-class therapy that promotes neuroprotection, neurogenesis, and memory enhancement. Phase 2 trials demonstrated its disease-modifying potential with a favorable safety profile compared to traditional anti-amyloid drugs. In this upcoming Phase 3 study, NA-831 will be evaluated in combination with Donanemab, a recently FDA-approved monoclonal antibody, to explore synergistic effects. The goal is to lower Donanemab dosing, thereby reducing risks such as cerebral edema and microbleeds, while enhancing cognitive outcomes. “NA-831 is the only drug to date that has halted disease progression in Phase 2 trials,” said Dr. Lloyd Tran, CEO of Biomed Industries. “Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.” 3. PRESENTATION: Alzheimer’s and Rett Syndrome: Shared Mechanisms and Dual Therapeutic Potential Biomed also presented findings on NA-921, a structural analog of NA-831 developed for Rett syndrome, a rare X-linked neurodevelopmental disorder. NA-921 modulates MeCP2 expression, targeting the disorder’s core epigenetic dysfunction. A double-blind, placebo-controlled Phase 2/3 trial (ClinicalTrials.gov ID: NCT06849973) demonstrated promising results: Clinical Global Impression–Improvement (CGI-I) at week 12: NA-921: 3.60 | Placebo: 3.83 | P = 0.0020 | Effect size = 0.42 NA-921 was well tolerated, with a significantly improved safety profile compared to trofinetide: - Diarrhea: Trofinetide 82%, NA-921 24%, Placebo 19% - Vomiting: Trofinetide 29%, NA-921 9%, Placebo 11% - Fever: Trofinetide 9%, NA-921 5%, Placebo 4% These findings underscore a possible biological link between Alzheimer’s disease and Rett syndrome, opening new cross-indication opportunities for NA-831 and NA-921. 4. PRESENTATION: Neuro-Metabolic Connections: NA-831 and NA-931 in Alzheimer’s and Obesity Biomed’s data also revealed compelling evidence of a neuro-metabolic bridge between Alzheimer’s disease, diabetes, and obesity. In addition to NA-831’s CNS benefits, Biomed is advancing NA-931, an oral quadruple receptor agonist (IGF-1, GLP-1, GIP, and glucagon) designed to treat obesity. In a 13-week Multiple Ascending Dose (MAD) study: - Mean body weight reduction: Up to 13.8% at 150 mg daily, 12.4% greater than placebo - ≥12% weight loss achieved by 72% of NA-931-treated patients vs. 2% in placebo group NA-931 demonstrated a strong safety profile, with mild and transient GI-related adverse events, and no observed muscle loss. “Our pipeline shows how targeting interconnected pathways across the CNS and metabolic systems can unlock significant clinical potential,” said Michael Willis, VP of Business Development. “With six active programs across Alzheimer’s, ALS, Rett syndrome, stroke, obesity, and MASH, we are building a diversified platform to accelerate innovation and value creation.” ABOUT BIOMED INDUSTRIES, INC. Biomed Industries, Inc. is a pioneering biopharmaceutical company committed to developing novel therapeutics that address unmet medical needs. Its innovative research platform has produced treatments for conditions including Alzheimer’s disease, ALS, Traumatic Brain Injury, Major Depressive Disorder, Diabetes, Obesity, MASH, Stroke, and rare diseases such as Huntington Disease and Rett Syndrome. (Website: https://www.biomedind.com ) Michael Willis Biomed Industries, Inc. email us here Visit us on social media: LinkedIn X Biomed introduction video Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

「  本文共：15条资讯，阅读时长约：20分钟 」药研资讯1. 诺和诺德口服GLP-1药物Amycretin在肥胖症II期试验中展现优越减重效果。诺和诺德（Novo Nordisk）公布了其口服GLP-1/胰淀素受体激动剂Amycretin的II期临床试验积极数据。结果显示，经过20周治疗，患者体重减轻幅度显著超过了Wegovy（司美格鲁肽）。这一结果可能预示着口服减重药物市场的下一个重大突破，引发了公司股价和业界的高度关注。2. 辉瑞（Pfizer）宣布以116亿美元收购一家专注于ADC药物的生物技术公司。辉瑞公司宣布达成最终协议，将以约116亿美元的价格收购生物技术公司Seagen。此次收购将极大增强辉瑞在抗体药物偶联物（ADC）领域的管线和技术平台，特别是在肿瘤治疗领域，被视为辉瑞应对专利悬崖、加强其癌症药物组合的关键战略举措。3. FDA批准首款用于治疗非酒精性脂肪性肝炎（NASH）的药物。美国食品药品监督管理局（FDA）今日批准了Madrigal Pharmaceuticals公司的Rezdiffra（resmetirom），用于治疗伴有中度至晚期肝纤维化的非酒精性脂肪性肝炎（NASH）。这是全球首款获批的NASH疗法，填补了巨大的未满足医疗需求，为数百万患者带来了希望。4. CRISPR基因编辑疗法在罕见遗传病β-地中海贫血的III期研究中获得成功。Vertex Pharmaceuticals和CRISPR Therapeutics联合宣布，其合作开发的exagamglogene autotemcel（exa-cel）在针对输血依赖性β-地中海贫血的III期临床试验中达到了主要终点和关键次要终点。绝大多数患者在接受治疗后摆脱了对输血的依赖，展示了基因编辑技术的巨大潜力。5. 罗氏（Roche）公布其阿尔茨海默病新药Gantenerumab的最新III期数据。罗氏公布了其皮下注射β-淀粉样蛋白抗体Gantenerumab在阿尔茨海mer病III期GRADUATE研究的最新分析数据。虽然未能达到主要临床终点，但数据显示其对特定亚组患者的生物标志物有积极影响。公司表示将继续探索其潜力，引发了学界对阿尔茨海默病治疗路径的进一步讨论。6. Moderna启动针对新型冠状病毒变种的mRNA疫苗III期临床试验。随着新一轮新冠病毒变种的出现，Moderna宣布启动其最新一代COVID-19疫苗的全球III期临床试验。该疫苗旨在提供针对当前主要流行株的更强和更持久的保护。7. 默沙东（MSD）Keytruda联合化疗获批用于治疗特定类型的晚期胃癌新适应症。美国FDA批准了默沙东的PD-1抑制剂Keytruda（帕博利珠单抗）联合曲妥珠单抗和化疗，用于一线治疗HER2阳性的晚期胃或胃食管交界处腺癌。这为胃癌患者提供了一个重要的免疫治疗新选择。8. 礼来（Eli Lilly）公布其下一代GIP/GLP-1R激动剂Retatrutide在2型糖尿病中的III期研究数据。礼来公司公布了其三重激动剂Retatrutide在治疗2型糖尿病患者的III期试验中的积极顶线结果。数据显示其在降糖和减重方面均表现出非常强劲的效力，有望成为继替尔泊肽（Tirzepatide）之后的又一重磅产品。9. 拜耳（Bayer）剥离其部分消费者健康业务，以更专注于处方药和农业科学。为应对财务压力和聚焦核心业务，拜耳集团宣布计划出售其部分知名的消费者健康品牌组合。此举旨在精简公司结构，将更多资源投入到医药和作物科学的创新研发中。10. CAR-T细胞疗法在实体瘤领域取得新进展：一项针对胶质母细胞瘤的早期研究结果积极。一家新兴生物技术公司公布了其新型CAR-T细胞疗法在治疗复发性胶质母细胞瘤（GBM）的I期临床试验中的初步数据。结果显示，该疗法具有良好的安全性，并在部分患者中观察到了肿瘤缩小的迹象，为CAR-T技术攻克实体瘤带来了新希望。11. 安进（Amgen）心血管重磅药物Repatha（瑞百安）的一项新适应症申请获欧洲药品管理局（EMA）受理。安进公司宣布，欧洲药品管理局已受理其PCSK9抑制剂Repatha用于降低特定高危人群主要心血管事件风险的新适应症上市许可申请。12. 百时美施贵宝（BMS）与一家AI药物发现公司达成数亿美元的合作协议。百时美施贵宝宣布与一家领先的人工智能（AI）药物研发公司达成战略合作，旨在利用AI平台发现和开发针对数个肿瘤学和免疫学靶点的新型小分子疗法。该合作总金额可达数亿美元。13. 吉利德科学（Gilead Sciences）公布其长效HIV药物Lenacapavir的最新预防数据。吉利德公布了其每年两次的衣壳抑制剂Lenacapavir作为HIV暴露前预防（PrEP）用药的一项关键研究数据，显示出极高的保护效力。长效剂型将极大改变HIV的预防格局。14. 全球首个基于RNAi技术的降胆固醇药物Leqvio在中国的商业化上市。诺华（Novartis）宣布其RNA干扰（RNAi）疗法Leqvio（inclisiran）已在中国正式上市。该药物每年仅需注射两次，为高胆固醇血症患者提供了长效、便捷的治疗新选择。15. 赛诺菲（Sanofi）投资开发新型抗生素以应对“超级细菌”耐药性危机。面对全球日益严重的抗生素耐药性问题，赛诺菲宣布对一家专注于开发新型抗菌药物的生物技术公司进行战略投资，并与其展开合作，共同研发能够对抗多重耐药菌的新一代抗生素。股市资讯8月1日A股医药公司涨幅TOP 3百济神州（688235.SH） +18.25%主要影响因素：PD-1单抗替雷利珠单抗获FDA批准用于胃癌一线治疗，成为首个在美获批该适应症的国产PD-1。康希诺（688185.SH） +14.36%主要影响因素：与Gavi签署15亿美元新冠疫苗预购协议，覆盖中低收入国家2026年需求。华东医药（000963.SZ） +11.78%主要影响因素：GLP-1受体激动剂利拉鲁肽类似药获批上市，定价较原研低40%。8月1日A股医药公司跌幅TOP 3ST康美（600518.SH） -5.00%主要影响因素：因持续经营能力存疑被实施退市风险警示。华大基因（300676.SZ） -4.35%主要影响因素：新冠检测业务继续萎缩，上半年净利润同比下滑52%。以岭药业（002603.SZ） -3.12%主要影响因素：连花清瘟海外销售不及预期，遭多家投行下调目标价。8月1日港股医药公司涨幅TOP 3信达生物（01801.HK） +22.17%主要影响因素：与赛诺菲达成50亿美元双抗ADC合作，首付款3亿美元创国内纪录。药明生物（02269.HK） +16.89%主要影响因素：宣布新建全球最大生物药CDMO基地，总投资100亿元。金斯瑞生物（01548.HK） +13.45%主要影响因素：CAR-T疗法获欧盟批准用于多发性骨髓瘤二线治疗。8月1日港股医药公司跌幅TOP 3中国生物制药（01177.HK） -7.23%主要影响因素：核心产品安罗替尼遭医保局重点监控，预计年销售额减少30%。石药集团（01093.HK） -5.67%主要影响因素：阿尔茨海默病药物III期临床数据不及预期，终止研发。三生制药（01530.HK） -4.89%主要影响因素：大股东折价12%减持8000万股，套现约6亿港元。评审动态8月1日新药临床试验申请IND7月新药上市申请NDA（申请类型为新药或进口，不包括仿制&已有国家标准）END