ST-266

近年来，随着全球医药市场竞争愈加激烈，企业对新药研发投入不断增加，促进新的药物靶点及治疗方式不断被发现和应用。同时，伴随着国内鼓励创新药研发政策逐步明确，创新药也将出现新市场机会。因此对全球新药研发进展的关注愈发强烈。基于医药魔方NextPharma全球新药数据库，我们每月定期发布《全球新药研发进展报告》。该报告专注于收录以下几类重要进展：1）临床结果类：新靶点的 POC/FIRST IN HUMAN 试验结果披露，注册性临床试验结果披露，挑战标准疗法的头对头试验结果披露；2）注册进展类：突破性疗法，FIRST IN CLASS/BEST IN CLASS 产品首次获批等信息，同时我们会盘点上月全球医药研发相关的重要核心数据，并总结为三份表格：1、每月全球批准创新药统计 2、每月全球获得特殊审评审批药品统计 3、每月全球肿瘤领域发起的核心临床研究统计。通过该报告的复盘表格与内容可帮助用户清晰回顾每月药品动态，挖掘相关信息，助力企业随时调整发展策略。扫码下载完整报告【5月全球核心数据统计】2022年5月，据医药魔方NextPharma数据库统计，全球一共有31款创新药获批(仅统计新分子实体或新复方组合，不含中药、仿制药及微创新产品)，包括2款在中国首次获得批准上市的药品以及8款在全球其他国家或地区获批，但国内还没有申报的药品。同时报告针对每一款获批新药目前各靶点各适应症的面临的竞争情况做了简单梳理，具体信息见下图:表格部分截图2022年5月，全球一共有29款创新药获得特殊审批审批资格(突破性疗法、孤儿药资格、快速通道以及优先审评)，包括2款获得突破性疗法的药品、8款获得快速通道的药品、18款获得孤儿药资格的药品以及2款获得罕见儿科用药资格的药品(注：ST266同时获得了孤儿药资格)。同时报告针对每一款新药目前在国内的研发阶段做了相应统计，具体信息见下图:表格部分截图2022年5月，根据医药魔方NextClinTrail核心临床数据库，肿瘤领域内全球一共发起了14项高质量的核心临床研究。包含贝达药业BPI-16350针对HR阳性/HER2阴性局部晚期、复发或转移性乳腺癌患者的III期研究、复宏汉霖斯鲁利单抗针对小细胞肺癌的III期临床研究，具体信息见下图:表格部分截图【5月全球重要临床进展盘点】根据公开资料不完全统计，截止到 2022年5月31日，医药魔方为大家收录到了最近的全球新药重大研发进展共计16条。其中涉及药物获批上市信息3条，临床重大进展11条、医药重大交易及特殊审批途径2条，部分信息如下图：扫码下载完整报告更多报告长文解析！2021年中国医药行业十大发展趋势总结(附报告下载)报告下载 | 2022年4月全球医药交易报告报告下载 | 2022年4月全球新药研发进展报告报告下载 | 2022年3月全球新药研发进展报告

June 7, 2021 13:30 UTC Preliminary results show intranasally delivered ST266 is safe PITTSBURGH--(BUSINESS WIRE)-- Noveome Biotherapeutics., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced preliminary results of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in Glaucoma Suspect patients. The trial was conducted at the University of Pennsylvania by Ahmara Ross, M.D., Ph.D. and Kenneth Shindler, M.D., Ph.D. of the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA. ST266 is a novel “secretome”, a cell-free platform biologic containing hundreds of proteins and other growth factors involved in cellular healing and was administered as a targeted nasal spray using the SipNose, Ltd. Cribriform Targeted Device, for which Noveome recently announced a commercial license agreement ( .) The device is able to deliver ST266 to the cribriform plate at the back of the upper nasal cavity where is able to reach the optic nerve, eye and brain, bypassing the blood-brain barrier. Previously published preclinical efficacy and distribution studies laid the groundwork for the Phase 1 clinical trial reported here. The Phase 1 open label clinical trial was designed to assess the safety of intranasally delivered ST266 in Glaucoma Suspect patients diagnosed as having pre-glaucoma conditions that have not yet caused damage to the optic nerve. Dosing occurred in three cohorts. In the first cohort, subjects were intranasally administered ST266 at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 28 days. No drug-related serious adverse events were reported. Preliminary safety assessments, reported here, were performed at baseline and at the end of drug treatment and included visual acuity, slit lamp exam, tonometry, retina exam and ERG, OCT for optic nerve fiber thickness layer, corneal pachymetry, gonioscopy, neuro-cognitive exam, MRI, lumbar puncture, chemistry panel, hematology, and nasopharyngeal exam. All results were normal. Three-, six- and twelve-month safety follow-up visits are planned for all subjects. More information about the study is available at under the identifier NCT03901781. “The preliminary safety results of this Phase 1 clinical trial of intranasally delivered ST266 is an important milestone for Noveome. Now that we have established safety of ST266 by this route of administration, we are actively planning efficacy trials in a variety of neurological and ophthalmological indications,” said Christopher Velis, CEO of Noveome. “We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases.” About ST266 ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, neuroprotection, and modulation of inflammation. ST266 is produced by collecting proteins and other factors secreted by a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells collected from full term placentas which are normally discarded after birth. This secretome contains physiologic levels of multiple growth factors and cytokines and stimulates a variety of anti-inflammatory and neuroprotective responses in preclinical studies. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, A drug master been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications. About Noveome Biotherapeutics, Inc. Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. In addition to the Phase 1 trial reported above, Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). The company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a Phase 2 clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit .