Receptor Life Sciences, Inc.

关注并星标CPHI制药在线 近日，clinicaltrials网站显示，Bionomics启动了BNC210治疗社交恐惧症（简称社恐）的III期研究（AFFIRM-1）。 该研究是一项多中心、随机、双盲、安慰剂对照临床试验（n=332），旨在评估BNC210（225mg）对比安慰剂急性治疗社恐成人患者的疗效和安全性。研究的主要终点为主观焦虑量表（SUDS）评分。 BNC210是Bionomics开发的一款靶向α7烟碱乙酰胆碱受体（α7 nAChR）的负向变构调节剂，正在被开发用于治疗社恐和创伤后应激障碍（PTSD）。2021年12月，BNC210获FDA授予快速通道资格，用于治疗PTSD、其他创伤和压力源相关疾病、急性治疗社恐和其他焦虑相关疾病。 与临床目前使用的安定和其他苯二氮卓类药物以及氟西汀和其他择性5-羟色胺再摄取抑制剂(SSRIs)和5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRIs)相比，BNC210的优势包括：快速起效、不会出现过度镇静、无戒断症状、不会损伤记忆、无药物相互作用。BNC210这一新型口服片剂可迅速吸收并在大约1小时内达到最大血药浓度。        BNC210作用机制        图片来源：Bionomics公司官网 2023年3月，BNC210（225mg或675mg）治疗社恐的II期PREVAIL研究顺利完成。数据显示，相比于安慰剂组，BNC210组患者的SUDS评分未显著改善（评分差异为5.69分，P=0.165），但结果具有临床意义且显示出了BNC210有益于改善社恐患者焦虑症状的趋势。对入组患者进行年龄分层并重新分析后，Bionomics发现BNC210在改善年轻（≤30岁）社恐患者人群的焦虑症状上的有益趋势更明显（评分差异为10.57分，P=0.069）。 社交焦虑障碍（SAD） “社恐”这一词汇，在被广泛的传播、诠释和使用的同时，已然成为一个网络热词。作为“社交恐惧症患者”的简称，它最初来源于一种疾病名称——社交焦虑障碍（Social anxiety disorder），也被称为社交恐惧症，是一种焦虑症，其特征是在一个或多个社会情境中有大量的恐惧，在日常生活的至少某些部分造成相当大的痛苦和能力受损。可能包含一定的身体症状通常包括脸红、出汗过多、 颤抖、心悸和恶心，口吃和语速快可能同时存在，严重时可以构成惊恐发作。 在医学上，日常生活中的害羞和社交恐惧症的不同之处在于：前者在每个人身上都有，但一定时间后会逐渐消失；而后者则是需要治疗的病症。和害羞不同，社交恐惧症是一种对难堪和出丑的极其强烈的或令人身心疲惫的恐惧感。 SAD 发病机制复杂，目前研究认为，疾病的发生发展涉及生物和环境等多因素相互作用。有研究发现，在 SAD 患者边缘系统中，参与形成情绪反应（尤其是恐惧反应）的杏仁核过度活跃。而其中与焦虑相关的神经递质如 5-羟色胺、去甲肾上腺素、多巴胺和氨基丁酸（GABA）也存在异常。        SAD 的病因分析        图片来源：丁香园 目前，对 SAD 的一线疗法包括广泛应用于焦虑症治疗的认知行为疗法（CBT）和药物治疗。药物通常包括选择性 5-羟色胺再摄取抑制剂（SSRIs）、5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRIs）、和苯二氮卓类（GABA-A 受体激动剂）药物。 不过，SSRIs 和 SNRIs 起效缓慢，需连续服用数周，且治疗效果有限，而苯二氮卓类药物目前还是一种未经 FDA 批准的超说明书用药。截至目前，还没有针对 SAD 的急性治疗药物获批上市。 全球仅三款在研，PH94B临床3期结果积极 Fasedinol(PH94B)是一款GABAA受体调节剂，其以微克剂量通过鼻腔喷雾给药，无味、起效快（15min内）且使用便利。根据Vistagen公司的官方介绍，区别于当前所有的抗焦虑药物，PH94B的独特性在于激活外周鼻化学感应神经元，触发大脑中抑制恐惧和焦虑的神经回路，而不是直接激活GABA-A受体或者直接作用于大脑的中枢神经系统，因此不需要全身摄取，安全性相对更高。2019年12月，美国FDA授予PH94B快速通道资格，用于按需治疗社交焦虑症。蔼睦医疗拥有该产品在中国、韩国和东南亚地区的开发和商业化权益。2022年1月，PH94B获得中国国家药监局药品审评中心（CDE）临床试验默示许可，拟开发用于成人社交焦虑障碍的焦虑症状，这也是社恐鼻喷剂首次在国内获批临床。        PH94B的作用机制        图片来源：Vistagen官网 去年8月，PH94B鼻喷剂在治疗社交焦虑症（SAD）成人患者的临床3期PALISADE-2试验中达到主要终点。与安慰剂相比，fasedienol组患者主观痛苦单位量表（SUDS）评分显著快速下降。Vistagen在新闻稿中表示，这是美国15年来首个社交焦虑障碍在研疗法在3期试验中获得积极结果。 Vistagen公布的是名为PALISADE-2的多中心、随机双盲、安慰剂对照3期研究，共纳入141例成人患者，旨在评估PH94B治疗社交恐惧症的有效性和安全性。结果显示，试验达到主要疗效终点，与安慰剂相比，PH94B组患者的平均SUDS评分对比安慰剂组显著下降（-13.8分 vs. -8.0分）；此外PH94B组患者的应答率也显著高于安慰剂组（40.6% vs. 18.6%），应答率通过临床整体印象-改善（CGI-I）量表评估，定义为焦虑程度大大降低或焦虑程度低得多的患者比例。安全性方面，试验中PH94B鼻喷剂耐受性良好，未发现重度或严重不良事件。 今年4月，Vistagen宣布启动PALISADE-3临床3期试验，该试验评估其在研fasedienol（PH94B）鼻喷剂用于急性治疗社交焦虑症（SAD）成人患者的疗效与安全性。Vistagen计划在2024年下半年启动另一项相同的3期临床试验PALISADE-4，以推动fasedienol成为首个SAD疗法。 除Fasedinol(PH94B)和BNC210处于临床3期外，目前全球还有两款用于治疗社交焦虑的大麻二酚类药物处于临床阶段。 近日，北美处方药服务提供商EmpowerPharm®公布大麻二酚（CBD）药物治疗社交焦虑障碍的2期临床试验结果。该试验评估了大麻二酚药物的剂量，疗效，安全性和耐受性，结果表明，对于患有中度至重度SAD的一部分患者有效。这些结果将指导进一步的临床研究和3期临床的设计。 EmpowerPharm®基于自纳米乳化药物递送系统（SNEDDS）技术的正在申请专利的药物制剂开发此产品。这是一种处方大麻二酚药丸，有望成为世界上第一种被批准用于治疗社交焦虑症的CBD处方药。 另一款RLS103是一种干粉吸入式大麻二酚（CBD），是一种用于急性治疗社交焦虑症的第一类药物/设备组合产品，使用吸入制剂技术与呼吸动力装置相结合。RLS103有可能在三分钟或更短的时间内为患有社交焦虑症的患者提供即时缓解。 2022年3月30日，开发创新疗法以解决中枢神经系统疾病的制药公司Receptor Life Sciences宣布，美国食品药品监督管理局（FDA）接受了RLS103的新药研究（IND）申请。目前RLS103（吸入、干性） Powder CBD）在患有社交焦虑症 （SAD） 的成年患者中的急性焦虑症的 1b/2a 期临床研究正在进行中。 结语 目前，SAD仍然属于小众的新药开发领域，在国内还是一片空白。目前，焦虑症在国内的患病率已高达4.98%，约有8000万患者。但SAD作为焦虑症中的一个类别，在国内的市场现在很难预估，原因在于，疾病识别率低、治疗率低。目前进展最快的SAD新药fasedienol最终结果还没有出来，更不提真正上市、商业化是在何时，未来仍有很长的路要走。目前已有多款新机制药物在此领域取得了积极进展，春天或许已经到来。 参考来源        1.Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol(PH94B) Nasal Spray in Social Anxiety Disorder.        2.Tillfors M, Furmark T, Marteinsdottir I, et al. Cerebral blood flow in subjects with social phobia during stressful speaking tasks: a PET study[J]. American journal of psychiatry, 2001, 158(8): 1220-1226.        3.Martin E I, Ressler K J, Binder E, et al. The neurobiology of anxiety disorders: brain imaging, genetics, and psychoneuroendocrinology[J]. Psychiatric Clinics, 2009, 32(3): 549-575. END 【智药研习社直播预告】 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

The prevalence of Epilepsy has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Epilepsy and the growing research and development activities to develop novel therapies to treat Epilepsy to drive the market. The companies developing the potential therapies in the last stage of development include Xenon Pharmaceuticals, Engage Therapeutics, Janssen Biotech, and several others LAS VEGAS, April 11, 2023 /PRNewswire/ -- DelveInsight's ' Epilepsy Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline epilepsy therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the epilepsy pipeline domain. Key Takeaways from the Epilepsy Pipeline Report DelveInsight's epilepsy pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for epilepsy treatment. Key epilepsy companies such as Alexza Pharmaceuticals, Xenon Pharmaceuticals, GW Pharmaceuticals, Equilibre Biopharmaceuticals, Takeda Pharmaceuticals, Abide therapeutics, Otsuka pharmaceutical, H. Lundbeck A/S, Spark Therapeutics, Equilibre Biopharmaceuticals, ES Therapeutics, Supernus Pharmaceuticals, Inc., MGC Pharmaceuticals, Engrail Therapeutics INC, SK biopharmaceuticals, Longboard Pharmaceuticals, Janssen Research & Development, LLC, Equilibre Biopharmaceuticals, Cerevel Therapeutics, LLC, Neurona Therapeutics, Praxis Precision Medicines, UCB Pharma, Receptor Life Sciences, NeuroPro Therapeutics, Inc., Avicanna, Amring Pharmaceuticals Inc., Ovid Therapeutics, Addex Therapeutics, IAMA Therapeutics, CODA Biotherapeutics, Cerebral Therapeutics, Engrail Therapeutics, and others are evaluating new epilepsy drugs to improve the treatment landscape. Promising epilepsy pipeline therapies in various stages of development include Alprazolam, XEN1101, XEN-496, XEN 901, GWP42006, EQU-001, TAK-935, Lu AG06466, OPC-214870, CG 01, EQU-001, ES-481, SPN-817, MGCND00EP1, NBI 827104, ENX-101, Cenobamate, SKL-24741, LP-352, JNJ-40411813, EQU-001, CVL-865, NRTX 1001, PRAX 628, Padsevonil, RLS103, NPT 2042, AVCN-319302, PRAX-020, AMZ002, OV 350, IAMA-6, CT-010, ENX-101, and others. In March 2023, IAMA Therapeutics, a preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, announced that preclinical data supporting its IAMA-6 program in focal refractory epilepsy will be presented at the 75th American Academy of Neurology (AAN) Annual Meeting, taking place on April 22-27 in Boston, Massachusetts. In February 2023, Addex Therapeutics announced that enrollment into Part 1 of Phase 2 clinical study of ADX71149 (JNJ-40411813) for the treatment of epilepsy had been completed. ADX71149 is a selective metabotropic glutamate type 2 (mGlu2) receptor-positive allosteric modulator (PAM). Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, is conducting the trial. In January 2023, Equilibre Biopharmaceuticals Corp., reported positive topline results from the Phase 2 clinical trial evaluating the clinical safety, tolerability, and preliminary efficacy of EQU-001 – a novel anti-inflammatory anti-seizure medication - administered as once-daily oral adjunctive therapy for focal seizures in adults with epilepsy. The results of the EQU-001 study are encouraging because they demonstrate impressive tolerability and encouraging efficacy for adult patients with focal epilepsy, especially for those with seizures that are difficult to treat. In January 2023, Signant Health, introduced a novel electronic diary (eDiary) data capture solution designed to simplify the experience for patients and research sites participating in epilepsy trials while ensuring robust outcome assessment data to support trial endpoints. Developed in collaboration with The Epilepsy Study Consortium (TESC), the new patient-reported outcome measure offers clinical research sponsors and organizations a standardized solution to capture common seizure data elements with high-quality data. In June 2022, CODA Biotherapeutics, Inc. announced that preclinical data from the Company's focal epilepsy program demonstrated that treatment with the Company's lead-engineered receptor and small molecule activator drug significantly reduced focal seizure frequency in vivo. Results showed that the rapid reduction in seizures is consistent with the pharmacokinetics of the activator drug in mouse models. Data also demonstrated that the expression of CODA's lead receptor is highly correlated with a reduction in seizure frequency. In September 2022, Avicanna Inc. was pleased to announce that it has expanded its research collaboration in the field of Epilepsy with a new collaboration with the University of Toronto and Dr. Mac Burnham's research team to explore the efficacy of Avicanna's proprietary formulations in pre-clinical models for Epilepsy. The research collaboration led by Dr. Mac Burnham's team will explore the efficacy of Avicanna's drug candidates, including AVCN319302, in animal models for Epilepsy. In December 2022, Praxis Precision Medicines, Inc. and UCB announced a strategic collaboration, based upon Praxis' PRAX-020 program, for the discovery of small molecule therapeutics as potential treatments of KCNT1-related epilepsies. Under the terms of the collaboration, UCB retains an exclusive option to in-license global development and commercialization rights to any resulting KCNT1 small molecule development candidate. In January 2022, Ovid Therapeutics Inc. announced the company has entered into an exclusive license agreement with AstraZeneca for a library of early-stage small molecules targeting the KCC2 transporter, including lead candidate OV350. The company seeks to optimize and accelerate the development of these KCC2 transporter activators in epilepsies and potentially other neuropathic conditions. In August 2021, Marinus Pharmaceuticals, Inc. announced that it has entered into an agreement with Orion Corporation whereby Orion received exclusive rights to commercialize the oral and intravenous (IV) dose formulations of ganaxolone in the European Economic Area, United Kingdom, and Switzerland for CDKL5 deficiency disorder (CDD), tuberous sclerosis complex (TSC) and refractory status epilepticus (RSE). Request a sample and discover the recent advances in epilepsy drug treatment @ Epilepsy Pipeline Report The epilepsy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage epilepsy drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the epilepsy clinical trial landscape. Epilepsy Overview Epilepsy is a chronic condition characterized by unprovoked, recurrent seizures. A seizure is an uncontrollable surge of electrical activity in the brain. Seizures are classified into two types. Seizures that affect the entire brain are known as generalized seizures. Focal seizures, also known as partial seizures, affect only one part of the brain. A mild seizure can be difficult to detect. It can last a few seconds, and you are unaware of it. Stronger seizures, lasting from a few seconds to several minutes, can cause spasms and uncontrollable muscle twitches. Epilepsy symptoms vary according to the area of the brain where seizure activity occurs and the type of seizure. Epilepsy symptoms may include: stiff muscles, Become stiff and falling backward, muscles relaxing and going floppy, confusion, breathing becomes difficult, unconscious, visual disturbances/hallucinations, uncontrollable jerking and shaking, called a "fit," losing awareness and staring blankly into space, strange sensations, such as a "rising" feeling in the tummy, unusual smells or tastes, and a tingling feeling in your arms or legs and collapsing. Epilepsy treatment can help most people with epilepsy have fewer seizures or completely stop having seizures. Find out more about drugs for epilepsy @ New Epilepsy Drugs A snapshot of the Epilepsy Pipeline Drugs mentioned in the report: Learn more about the emerging epilepsy pipeline therapies @ Epilepsy Clinical Trials Epilepsy Therapeutics Assessment The epilepsy pipeline report proffers an integral view of epilepsy emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Epilepsy Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: KCNQ potassium channel agonists, Monoacylglycerol lipase inhibitors, Cholesterol 24-hydroxylase inhibitors, NMDA receptor modulators, AMPA receptor antagonists, GABA A receptor agonists, Cannabinoid receptor modulators Key Epilepsy Companies: Alexza Pharmaceuticals, Xenon Pharmaceuticals, GW Pharmaceuticals, Equilibre Biopharmaceuticals, Takeda Pharmaceuticals, Abide therapeutics, Otsuka pharmaceutical, H. Lundbeck A/S, Spark Therapeutics, Equilibre Biopharmaceuticals, ES Therapeutics, Supernus Pharmaceuticals, Inc., MGC Pharmaceuticals, Engrail Therapeutics INC, SK biopharmaceuticals, Longboard Pharmaceuticals, Janssen Research & Development, LLC, Equilibre Biopharmaceuticals, Cerevel Therapeutics, LLC, Neurona Therapeutics, Praxis Precision Medicines, UCB Pharma, Receptor Life Sciences, NeuroPro Therapeutics, Inc., Avicanna, Amring Pharmaceuticals Inc., Ovid Therapeutics, Addex Therapeutics, IAMA Therapeutics, CODA Biotherapeutics, Cerebral Therapeutics, Engrail Therapeutics, and others. Key Epilepsy Pipeline Therapies: Alprazolam, XEN1101, XEN-496, XEN 901, GWP42006, EQU-001, TAK-935, Lu AG06466, OPC-214870, CG 01, EQU-001, ES-481, SPN-817, MGCND00EP1, NBI 827104, ENX-101, Cenobamate, SKL-24741, LP-352, JNJ-40411813, EQU-001, CVL-865, NRTX 1001, PRAX 628, Padsevonil, RLS103, NPT 2042, AVCN-319302, PRAX-020, AMZ002, OV 350, IAMA-6,CT-010, ENX-101, and others. Dive deep into rich insights for new drugs for epilepsy treatment; visit @ Epilepsy Medications Table of Contents For further information on the epilepsy pipeline therapeutics, reach out @ Epilepsy Drug Treatment Related Reports Epilepsy Market Epilepsy Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key epilepsy companies including Takeda Pharmaceuticals, Abide therapeutics, Otsuka pharmaceutical, among others. Epilepsy Epidemiology Forecast Epilepsy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epilepsy epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Refractory Epilepsy Pipeline Refractory Epilepsy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key refractory epilepsy companies, including Eisai Co.LTD., Alexza Pharmaceuticals, Xenon Pharmaceuticals, among others. Partial Epilepsy Pipeline Partial Epilepsy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key partial epilepsy companies, including GW Pharmaceuticals, Equilibre Biopharmaceuticals, among others. Refractory Epilepsy Market Refractory Epilepsy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key refractory epilepsy companies including Eisai Co.LTD., Alexza Pharmaceuticals, Xenon Pharmaceuticals, among others. Partial Epilepsy Market Partial Epilepsy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key partial epilepsy companies, including GW Pharmaceuticals, Equilibre Biopharmaceuticals, among others. 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SEATTLE--(BUSINESS WIRE)-- Receptor Life Sciences (RLS), a pharmaceutical company developing innovative therapies to address central nervous system disorders, is expanding the potential clinical utility of RLS103 into epilepsy. A proof-of-concept clinical safety and efficacy study in epilepsy will be conducted under a second, recently opened IND application. The Phase 1b randomized, double-blind, placebo-controlled, crossover study will evaluate RLS103 in patients with photosensitive epilepsy as a model for REST. RLS103, a dry powder inhaled cannabidiol (CBD), is a first-in-class drug/device combination product for the acute treatment of psychiatric and neurological disorders. Epilepsy study startup is underway. “As the parent of a child with epilepsy, I recognize the need for a product that can terminate a seizure as soon as possible, without sedation,” said Mark Theeuwes, President and CEO of Receptor Life Science. “RLS103 could address that need as the first non-scheduled, non-sedating seizure rescue therapy. Advancing our lead drug candidate, RLS103, into a second proof-of-concept clinical study demonstrates our continued commitment to treating central nervous system conditions in collaboration with FDA.” “Many patients with epilepsy have recognizable auras that precede a seizure,” said Orrin Devinsky, MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine. “A treatment capable of terminating a seizure at the aura stage would be a life-changing therapy for these patients. This study is designed to be the first proof-of-concept clinical trial of RLS103 in epilepsy, and will be a study of significant interest for epileptologists and patient communities.” According to the Epilepsy Foundation, seizure disorder affects about 3.4 million people in the United States. About Receptor Life Sciences Receptor Life Sciences is a pharmaceutical company that applies FDA-approved drug delivery technologies to develop innovative therapies to address central nervous system disorders that have few safe and effective treatments. Receptor Life Sciences uses these technologies to produce inhaled and oral cannabinoid products that hold the potential to provide precision, consistency, reliability, and convenience. For more information about Receptor Life Sciences, its patented product candidates and its progress toward FDA approval, see .