Gabapentin

PRINCETON, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel, injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will be participating in the BIO International Convention taking place at the San Diego Convention Center from June 3-6, 2024. During the conference, Prashant Kohli, Chief Executive Officer of Acasti, will host meetings with pharmaceutical executives to explore partnership and strategic opportunities for the Company’s asset portfolio. To connect during the conference, please request a meeting via the BIO International meeting portal or contact mmoyer@lifesciadvisors.com. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. About the Acasti Asset Portfolio GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous infusion (IV) in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTX-104 is estimated to be about $300 million, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. GTX-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. GTX-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (“PHN”). GTX-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTX-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. About Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti's novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti's lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti's lead clinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.acasti.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company's anticipated cash runway, the timing of the planned NDA submission with the FDA in connection with the Company's STRIVE-ON trial, GTX-104’s commercial prospects, and GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH are based upon Acasti's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 safety trial for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Acasti Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email: info@acastipharma.comwww.acasti.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

编者按：本文来自药智网，作者四月的雨；赛柏蓝授权转载，编辑yuki近日，由海思科研发的1类新药苯磺酸克利加巴林胶囊（思美宁）正式获国家药监局批准上市，适应症为成人糖尿病性周围神经病理性疼痛（DPNP）。思美宁为GABA衍生物，是一款无需滴定的口服钙离子通道调节剂，可为神经疼痛患者提供更好的帮助。01思美宁VS普瑞巴林谁更胜一筹？目前，国内DPNP患者众多，在思美宁获批之前，国内尚无该领域国产创新药获批，常用的缓解药物为加巴喷丁类药物（包括加巴喷丁、普瑞巴林和美洛加巴林），此类药物被美国糖尿病协会推荐为治疗DPNP的首选药物。思美宁治疗DPNP的临床3期数据显示，相比于普瑞巴林组，思美宁组受试者在接受40mg、80mg剂量的药物治疗后，疼痛评分呈现快速下降趋势。经过5周的治疗，疼痛评分也显示出优于普瑞巴林。结合临床数据，思美宁效果要优于普瑞巴林，用药剂量低、镇痛效果及安全性好、并且无需滴定。图1 思美宁与普瑞巴林临床对比图片来源：参考文献[1]值得注意的是，目前DPNP药物除思美宁以及加巴喷丁类药物外，还有多款药物处于临床阶段，多数处于临床2期阶段，详见下表1。表1 DPNP在研药物（部分）数据来源：药智数据02国内DPNP药物紧缺思美宁将填补空白DPNP是指由糖尿病或糖尿病前期导致的周围神经病理性疼痛，根据国际糖尿病联盟（IDF）官网数据，我国2021年糖尿病患者已经达到1.4亿人，预计2030年将超过1.6亿人。而《糖尿病神经病变诊治专家共识（2021年版）》数据显示，约有50%的糖尿病患者会发生糖尿病周围神经病变，其中又有50%的人会出现DPNP，因此约有25%的糖尿病患者会出现DPNP，由此估算我国DPNP患者多达3000万人。治疗药物方面，以普瑞巴林原研药乐瑞卡为例，其巅峰销售额达52亿美元。适应症方面陆续被批准用于糖尿病性周围神经痛、带状疱疹后遗神经痛（PHN）、癫痫部分性发作辅助治疗、肌纤维痛以及脊髓损伤引起的神经病理性疼痛的辅助治疗等，其2005-2014年销售额增长速度达38%。如今国内DPNP治疗药物紧缺，随着思美宁的获批上市，将填补我国DPNP治疗领域的空白。从国内市场竞争格局来看，普瑞巴林DPNP适应症在我国还未被批准，同类药物mirogabalin国内也未曾上市。因此思美宁国内市场良好，竞争压力较小。对于普瑞巴林每月治疗费用，假设患者每天服用150mg药物，200ml：4000mg/瓶规格的普瑞巴林价格为152.63元，由此计算出患者每月需花费170元（如需要更高剂量，费用相应增加）。由此可假设思美宁每月费用200-300元，治疗周期为3个月，该药物若市场渗透率能达10%以上，那么单DPNP适应症，或许就足以支撑其20亿元的销售额，若后续其他适应症获批，其巅峰销售额将更高。参考文献[1]doi:10.2337/db23-224-OR.END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联