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生物制药公司SFA Therapeutics宣布SFA-002治疗银屑病的1b期试验完成入组

SFA Therapeutics Announces Completion of Enrollment in Phase 1b Trial of SFA-002 for Psoriasis

CISION 等信源发布 2024-05-30 21:00

可切换为仅中文


JENKINTOWN, Pa., May 30, 2024 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the completion of enrollment of 15 patients in cohort 2 of its Phase 1b clinical trial of SFA-002 for the treatment of mild-to-moderate chronic plaque psoriasis..

宾夕法尼亚州詹金敦(JENKINTOWN),2024年5月30日/PRNewswire/-SFA Therapeutics,Inc.,一家临床阶段的生物制药公司,开发用于治疗炎症性疾病的口服小分子生物合成化合物,今天宣布完成SFA-002治疗轻中度慢性斑块状银屑病1b期临床试验队列2中15名患者的登记。。

'This clinical milestone is essential to our ongoing evaluation of the safety and efficacy of SFA-002 for the treatment of psoriasis. As an endogenous biosynthetic compound, SFA-002 has the potential to be a disease-modifying therapeutic that targets multiple pathways with greater efficacy and less side effects for patients,' stated Dr.

“这一临床里程碑对于我们正在进行的SFA-002治疗牛皮癣的安全性和有效性评估至关重要。作为一种内源性生物合成化合物,SFA-002有可能成为一种疾病缓解疗法,针对多种途径,对患者具有更高的疗效和更少的副作用。

Stefan Weiss, Chief Medical Officer of SFA Therapeutics..

SFA Therapeutics首席医疗官斯特凡·韦斯(StefanWeiss)。。

'As we approach the conclusion of our Phase 1b trial, we look forward to entering Phase 2 studies in the second half of the year,' stated Ira Spector, Chief Executive Officer of SFA Therapeutics. 'The encouraging topline and safety results from cohort 1 of the Phase 1b clinical trial demonstrate the promise of SFA-002 to be a successful treatment for psoriasis.

SFA Therapeutics首席执行官艾拉·斯佩克特(IraSpector)表示:“随着1b期试验接近尾声,我们期待着在今年下半年进入第二阶段研究。”1b期临床试验队列1的令人鼓舞的基线和安全性结果表明SFA-002有望成为牛皮癣的成功治疗方法。

We anticipate additional Phase 1b data readouts from cohort 1 along with topline data from cohort 2 in the coming months.'.

我们预计未来几个月将有来自队列1的额外1b期数据读数以及来自队列2的topline数据。”。

SFA Therapeutics previously reported positive topline efficacy and safety results from cohort 1 of its Phase 1b clinical trial of SFA-002. In 14 evaluable subjects with difficult-to-treat scalp psoriasis and palmoplantar psoriasis, including six subjects on the three-month extension, 92% of patients demonstrated a PASI improvement of greater than 50.

SFA Therapeutics先前报道了其SFA-002 1b期临床试验队列1的阳性topline疗效和安全性结果。在14名难治性头皮牛皮癣和掌plant牛皮癣的可评估受试者中,包括6名延长三个月的受试者,92%的患者表现出PASI改善大于50。

72% of subjects showed an improvement of greater than PASI 75. Two subjects achieved PASI 100 (100% clearance). No related adverse events or toxicities were observed during the treatment period and follow-up, with no rebound effects observed..

72%的受试者表现出大于PASI 75的改善。两名受试者达到了PASI 100(100%清除率)。在治疗期间和随访期间未观察到相关的不良事件或毒性,未观察到反弹效应。。

About SFA Therapeutics

关于SFA Therapeutics

SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants.

SFA Therapeutics,Inc.是一家临床阶段的生物制药公司,开发用于治疗炎症性疾病的口服小分子生物合成化合物。根据天普大学(Temple University)授权的突破性研究,SFA Therapeutics平台有可能通过独特地定制具有靶向特异性佐剂的专利制剂的作用,为许多慢性炎症性疾病开发更安全和更有效的治疗方法。

Its lead asset, SFA-002, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis.

其主要资产SFA-002正在接近2期临床试验,并显示出治疗牛皮癣的有希望的1a期和1b期结果。美国食品和药物管理局(FDA)也批准了SFA Therapeutics的研究性新药(IND)申请,以研究代谢功能障碍相关脂肪性肝炎(MASH)患者的SFA-001N,也称为非酒精性脂肪性肝炎(NASH),有或没有纤维化。

SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer..

SFA Therapeutics被FDA指定为SFA-001治疗肝细胞癌(最常见的肝癌形式)的孤儿疾病。。

SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit www.sfatherapeutics.com to learn more.

SFA Therapeutics的总部位于宾夕法尼亚州的詹金敦。请访问www.sfatherapeutics.com了解更多信息。

Company Contact

公司联系人

Ira Spector, Ph.D.SFA Therapeutics, Inc.+1 267-584-1080

Ira Spector,SFA Therapeutics,Inc.博士+1267-584-1080

Media Contacts

媒体联系人

Tony Russo, Ph.D.Russo Partners, LLCTony@RussoPR.com

Tony Russo,Russo Partners博士,LLCTony@RussoPR.com

Maddie StabinskiRusso Partners, LLCMadeline@RussoPR.com

Maddie StabinsiRusso Partners,LLCMadeline@RussoPR.com

SOURCE SFA Therapeutics, Inc.

来源:SFA Therapeutics,Inc。