Difamilast

Clinical Study demonstrated dual benefit mode of action of Thykamine™ in mild-to-moderate Atopic Dermatitis: Statistically significant effect on Atopic Dermatitis evaluated by measure of IGA, BSA and POEM Statistically beneficial effect on Pruritis (‘‘itch’’) QUEBEC CITY--(BUSINESS WIRE)-- Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD ; OTCQB: DVHGF), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, today announced the publication of Thykamine™ positive phase 2 trial in adult patients with mild-to-moderate Atopic Dermatitis (AD) in the peer-reviewed Journal of Drugs in Dermatology (JDD). This article, titled ‘‘Phase 2 Trial of Topical Thykamine in Adults with Mild to Moderate Atopic Dermatitis’’ has been published in a JDD special issue focus on Atopic Dermatitis (J Drugs Dermatol 21(10): 1091-1097, October 2022). The paper by Lynde et al. discloses the results of the Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial conducted in 162 adult patients with mild-to-moderate AD. In this 4-week multicentre study, a significantly greater proportion of adult patients treated with Thykamine™ cream 0.10% achieved an IGA of clear/almost clear and at least a 2-grade improvement from baseline in IGA (30.8%) compared to placebo (6.7%; P =.014). The benefit of Thykamine™ cream 0.10% was supported by a statistically significant effect on secondary endpoints of Body Surface Area (BSA), pruritis, and Patient-Oriented Eczema Measure score (POEM). A significant reduction in %BSA affected from baseline was demonstrated at all study visits. These changes differentiated significantly from placebo from Day 14 until Day 29 (p ≤ 0.001). Pruritus (‘‘itch’’) was rapidly improved from baseline by Day 7 with a statistically difference vs placebo at Day 21 and Day 29 (p ≤ 0.01). POEM outcome was statistically significant from placebo at day 21 and 29 (p ≤ 0.01). Thykamine™, at all doses, was well tolerated with an adverse event pro placebo. ‘‘We are proud to have our innovative Thykamine™ study results published in a reputable, peer-reviewed scientific journal,” said Dr André P. Boulet, PhD, Chief Scientific Officer of Devonian. ‘‘The efficacy of Thykamine™ obtained in this clinical trial compared favourably to published results of other therapeutic products such as the phosphodiesterase inhibitors (PDE4)1,2 and calcineurin inhibitors.3 To our knowledge, it is the first time that clinical data revealed that a Botanical Drug candidate can be as potent as a product derived from chemical synthesis. Furthermore, the use of Thykamine™ was associated with a rapid improvement in itch in patients with mild to moderate AD. The fast onset of action and magnitude of itch relief associated with Thykamine™ cream treatment suggests that it may provide meaningful improvement in quality of life and addresses an unmet need for patients with AD,’’ added Dr Boulet. About Atopic Dermatitis (AD) AD, also known as eczema, is a type of inflammation of the skin. It results in itchy, red, swollen, and cracked skin that may lead to secondary infection. The condition typically starts in childhood with changing severity over the years. Although the cause of AD is unknown, it is believed to involve genetics, a compromised immune system and can be triggered by environmental factors. AD is the most common skin disease4 and its prevalence continues to increase worldwide. In the United States, the incidence has been reported to be 15-30% of children5. The severity of AD can be categorized into three stages, mild, moderate, and severe. The mild and moderate forms constitute approximately 67% and 26% respectively of the AD childhood patient population. A similar distribution has been reported in the adult patient population (71% and 26% respectively) 6,7. There is currently an enormous unmet need for new, effective, and well-tolerated treatment options in AD8. The global atopic dermatitis market is expected to exceed US $21,8 billion in sales by 20279. About Thykamine Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a phase II clinical study in patients with mild-to-moderate atopic dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. (Devonian)is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory-autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian’s flagship product, Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with Mild-to-Moderate distal Ulcerative Colitis and in a large phase 2 clinical trial in adult patients with Mild-to-Moderate Atopic Dermatitis. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Acquired in 2018, Altius Healthcare Inc., its commercialization subsidiary, brings opportunities for further diversification and growth potential. Devonian is listed on the TSX Venture Exchange (TSXV:GSD) as well as the OTCQB Venture Exchange (OTCQB:DVHGF) For more information, visit References Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesteras 4 (PDE4) inhibitors for the topical treatment of atopic dermatitis (AD) in children and adults. J. Am. Acad. Dermatol., Vol 75 (3), 494-503, 2016. Hanifin JM., Ellis CN, Frieden IJ, et al. OPA-15406, a novel topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (A): A phase-II randomized, double-blind, placebo-controlled study. J Am Acad Dermatol, Vol 75 (2), 297-305, 2016. Product Monograph, Elidel Cream 1%, Valeant Canada, 2014 Peng W., Novak N. Pathogenesis of atopic dermatitis. Clinical et Experimental Allergy 2015, 45 : 566-574. Amy Huang, MD, Christine Cho, MD, Donald Y.M. Leung, MD, PhD, and Kanwaljit Brar, MD. Atopic Dermatitis: Early Treatment in Children. Curr Treat Options Allergy. 2017 Sep; 4(3): 355–369. Silverberg JI, Simpson EL. Associations of childhood eczema severity: A US population-based study. Dermatitis 2014; 25(3):107-114. Chaplin S. Guide to treatments used for atopic dermatitis in adults. Prescriber 2016: 27(10): 30-39. Leung DYM. Guttman-Yassky E. Assessing the current treatment of atopic dermatitis: Unmet needs. J. of Allergy and Clinical Immunology. 2017; 139(4) Suppl.: S47-48. Market Data Forecast, Global Atopic Dermatitis Treatment Market Size, Share, Trends, COVID-19 Impact & Growth Analysis Report - Segmented By Treatment Type, Route Of Administration, Distribution Channel & Region - Industry Growth, Trends & Forecast (2021 to 2026), April 2021. Forward-Looking Statements This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, the intended use of proceeds of the Offering, the final approval of the TSX Venture Exchange in connection with the Offering, the above “About Devonian” paragraph, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

关注并星标CPHI制药在线       审批方面，NMPA来看，南京百鑫愉医药的2.2类新药依达拉奉舌下片、宜昌人福的3类仿制药氯巴占片获批上市，值得关注。同时，君实生物的特瑞普利单抗和阿斯利康的奥拉帕利片均有新适应症获批；EMA、FDA均有一些热门药物有新进展，比如，罗氏双抗眼科用药Faricimab欧盟获批上市。研发方面，有点平平无奇。交易及投融资方面，正大天晴与Inventiva达成合作协议，共同开发泛PPAR激动剂lanifibranor。此外，诺诚健华顺利在科创板上市。本周盘点包括审批、研发、交易及投融资、上市4个板块，统计时间为9.19-9.23，包含25条信息。审批//NMPA上市批准1、9月19日，NMPA官网发布批件，君实生物的PD-1单抗特瑞普利单抗新适应症获批上市，联合标准一线化疗用于未经治疗、驱动基因（EGFR/ALK）阴性的晚期非小细胞肺癌。这是特瑞普利单抗在中国获批的第6项适应症。2、9月19日，NMPA官网发布批件，阿斯利康/默沙东的PARP抑制剂奥拉帕利片新适应症获批上市，用于同源重组修复缺陷（HRD）阳性的晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在一线含铂化疗联合贝伐珠单抗治疗达到完全缓解或部分缓解后的维持治疗。这是奥拉帕利片在中国获批的第4项适应症。3、9月19日，NMPA官网发布批件，南京百鑫愉医药的2.2类新药依达拉奉舌下片获批上市，适应症为抑制肌萎缩侧索硬化（ALS）所致功能障碍的进展。南京百鑫愉医药成为首家获得依达拉奉舌下片上市批件的药企。4、9月19日，NMPA官网发布批件，宜昌人福的3类仿制药氯巴占片获批上市，用于治疗称为Lennox-Gastaut综合征（LGS）的难治性癫痫。氯巴占属于1,5-苯二氮䓬类新型抗癫痫药物，针对年龄≥2岁的儿童期和成人LGS患者癫痫发作疗效确切。申请5、9月21日，CDE官网显示，Orphalan5.1类新药四盐酸曲恩汀薄膜衣片已申报上市并获受理。曲恩汀是一种铜离子络合剂，此前已在海外获批用于治疗威尔逊病（又称肝豆状核变性）。这是一种罕见的慢性遗传病，在中国被纳入《第一批罕见病目录》。6、9月21日，CDE官网显示，祐儿医药和Tris Pharma联合开发的5.1类新药盐酸哌甲酯口服缓释干混悬剂已申报上市并获受理。盐酸哌甲酯属于一种中枢神经系统（CNS）兴奋剂，用于治疗注意缺陷多动障碍（俗称多动症），可在45分钟内起效。临床批准7、9月19日，CDE官网显示，大冢制药的Difamilast软膏获批临床，用于治疗儿童及成人特应性皮炎。Difamilast是一款非甾体类外用磷酸二酯酶-4（PDE4）抑制剂，通过阻抑细胞因子和化学介质的产生来发挥其抗炎作用。8、9月19日，CDE官网显示，瑞博生物的RBD7022注射液获批临床，用于治疗以低密度脂蛋白胆固醇升高为特征的原发性（家族性和非家族性）高胆固醇血症或混合型高脂血症。这是第一款由国内药企自主研发的针对ASGPR和PCSK9的siRNA疗法获批临床。9、9月20日，CDE官网显示，信达生物的IBI333获批临床，用于治疗新生血管性年龄相关性黄斑变性。IBI333是一款全人源融合蛋白双抗，可同时靶向VEGF-A和VEGF-C。在激光诱导的脉络膜新生血管模型中，IBI333可抑制游离的VEGF-A和VEGF-C。10、9月21日，CDE官网显示，原启生物的Ori-C101注射液获批临床，用于治疗晚期肝细胞癌。Ori-C101注射液是具有高特异性高亲和力的靶向GPC3全人源抗体序列和独特的信号激活元件Ori，拟用于治疗晚期肝细胞癌成人患者。申请11、9月19日，CDE官网显示，邦耀生物的BRL-201提交临床试验申请获受理。BRL-201是全球首个靶向CD19非病毒PD1定点整合的CAR-T产品，可在不使用病毒载体的情况下，通过一步制备获得基因组定点整合的CAR-T细胞产品。突破性治疗12、9月21日，CDE官网显示，乐普生物的注射用MRG003拟纳入突破性治疗品种，用于治疗既往经至少二线系统化疗（包括含铂化疗）和PD-1（L1）治疗失败的复发/转移性鼻咽癌。MRG003是一款靶向肿瘤细胞表面EGFR的ADC药物，通过抗体部分将细胞毒小分子精准递送至肿瘤细胞中。//FDA上市批准13、9月21日，礼来宣布，Selpercatinib（Retevmo）的新适应症获FDA加速批准，用于治疗转染重排（RET）基因融合的局部晚期或转移性实体瘤患者，这些患者在接受前期系统性治疗后发生疾病进展，或没有其它满意的替代治疗选择。这是全球首个且唯一一个不限癌种用于治疗RET基因融合实体瘤的RET抑制剂。申请14、9月20日，Cidara/Melinta Therapeutics共同宣布，FDA已受理雷扎芬净（rezafungin）上市申请，用于治疗念珠菌血症和侵袭性念珠菌病（IC），并授予其优先审查资格，PDUFA日期为2023年3月22日。IC是一种严重且危及生命的系统性念珠菌感染，可感染血流和/或深层/内脏组织。15、9月22日，Argenx宣布，FDA已受理皮下注射efgartigimod的生物制品许可申请（BLA），用于治疗全身型重症肌无力成人患者。Efgartigimod是一款靶向Fc受体的“first-in-class”疗法，已于2021年12月获FDA批准上市，再鼎医药拥有在大中华区开发和商业化的权利。孤儿药资格16、9月19日，德琪医药宣布，其自主开发的新型PD-L1/4-1BB双抗ATG-101注射液获FDA孤儿药资格认定，用于治疗胰腺癌。目前全球尚无获批用于治疗胰腺癌的PD-L1/4-1BB双抗。2021年12月，ATG-101注射液的临床试验申请获NMPA受理，用于治疗实体瘤及非霍奇金淋巴瘤，该产品为德琪医药首款双抗新药。//EMA上市批准17、9月19日，罗氏宣布，Faricimab（Vabysmo）已获EMA批准上市，用于治疗新生血管或湿性年龄相关性黄斑变性(nAMD)和糖尿病黄斑水肿(DME)。Faricimab是首个针对眼科疾病开发的VEGF-A/ANG-2双特异性抗体，也是目前欧洲唯一获批的可注射眼科药物。18、9月21日，阿斯利康宣布，Tezepelumab（Tezspire）已获EMA批准上市，作为12岁及以上严重哮喘患者的附加维持治疗。这是首个也是唯一一个获EMA批准的不受任何表型或生物标志限制用于治疗严重哮喘患者的生物制品。Tezspire是一款靶向TSLP的单抗，由阿斯利康与安进共同开发,已在美国和其他国家获批上市。申请19、9月20日，UCB宣布，EMA已接受bimekizumab的两项上市许可申请（MAA），用于治疗成人活动性银屑病关节炎（PsA）和活动性中轴型脊柱关节炎（axSpA）患者。这是全球唯一一款获批上市的抗IL-17A/IL-17F单抗。研发启动临床20、9月20日，默沙东宣布，将启动新的Ⅲ期临床试验，旨在评估一日一次口服给药Islatravir（100mg）与较低剂量Doravirine（0.75mg）组合疗法—DOR/ISL对HIV-1感染患者的疗效。目前，FDA已审查并同意该计划。Islatravir是一款在研的核苷逆转录酶易位抑制剂（NRTTI），其能够通过多种机制抑制HIV逆转录酶的功能。21、9月21日，药物临床试验登记与信息公示平台显示，复星医药启动了一项SurVaxM联合替莫唑胺辅助治疗初诊的胶质母细胞瘤的国际多中心（含中国）Ⅱ期临床试验。SurVaxM是MimiVax开发的一款多肽疫苗。复星医药于2019年获得该产品在中国的独家临床开发和商业化权利。临床数据公布22、9月21日，辉瑞公布了PF-06882961（每日口服2次）和PF-07081532（每日口服1次）的最新研究数据，结果显示，与安慰剂相比降糖减重效果显著。PF-06882961和PF-07081532均属于口服小分子GLP-1受体激动剂。目前，全球仅有1款口服GLP-1R激动剂司美格鲁肽片上市。23、9月19日，荣昌生物宣布，泰它西普（泰爱）治疗系统性红斑狼疮（SLE）患者的中国3期确证性研究已完成，并获得初步数据结果。研究达到了预设的临床终点，第52周SLE反应指数-4（SRI-4）应答率在泰它西普组为82.6%，安慰剂组为38.1%。交易及投融资24、9月21日，Inventiva宣布，其与正大天晴达成合作协议，共同开发和商业化Inventiva自主研发的泛PPAR激动剂lanifibranor，用于治疗非酒精性脂肪性肝炎（NASH）和潜在的其他代谢疾病。根据协议条款，Inventiva有可能获得高达2.9亿美元的临床、监管和商业里程碑付款。上市科创板25、9月21日，诺诚健华在上海证券交易所科创板正式上市。诺诚健华有两个获批上市的产品，分别是BTK抑制剂奥布替尼和抗CD19抗体tafasitamab。目前，该公司有13款产品正在全球开展30多项临床试验。-END-【企业推荐】智药研习社近期线上课程报名（支持回放）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~