-- SRC recommended that the trial escalate to the next dose level of 15mg capsule --
-- No dose-limiting toxicities (DLTs) observed to date --
-- No rash observed to date --
MIAMI, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that the external Safety Review Committee recommended proceeding to cohort 4, 15mg capsule, without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT's). In addition, no rash was observed in any of the first 9 patients who received PAS-004. The Company has decided to add a cohort 4b to the trial, which will consist of 3 additional patients and introduce an alternate formulation which is intended for commercial use.
Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, "We are pleased to observe that as we continue to dose escalate, we have not yet seen rash emerge. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice. In addition, we are excited to dose patients with our potential commercial formulation."
The Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or patients who have failed BRAF/MEK inhibition (NCT06299839).
PAS-004 Demonstrates a Differentiated MEK Inhibitor Profile
Unlike first-generation MEK inhibitors for the treatment of NF1 that require twice-daily dosing (BID) and exhibit short half-lives (<8 hours), PAS-004 has the potential to achieve prolonged target inhibition and once-daily dosing (QD) due to its long half-life of approximately 70 hours. As disclosed previously, the PK profile shows consistent plasma levels at steady-state, as reflected by a low Cmax to Cmin ratio, potentially reducing the risks for Cmax-related toxicity. These findings provide a compelling rationale for the advancement of PAS-004 into clinical trials for both the treatment of cutaneous and plexiform neurofibromas in NF1, cancer and other MAPK-driven opportunities. The company expects to provide additional trial updates on a periodic basis as the trial progresses.
About Pasithea Therapeutics Corp.
Pasithea is a biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and RASopathies. With an experienced team of experts in the fields of neuroscience, translational medicine, and drug development, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS).
Forward Looking Statements
This press release contains statements that constitute "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company's ongoing Phase 1 clinical trial and the safety, tolerability, pharmacokinetic (PK) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company's current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company's plans, assumptions, expectations, beliefs and objectives, the success of the Company's current and future business strategies, product development, preclinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.
Pasithea Therapeutics Contact
Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com
-- SRC建议试验提高到15mg胶囊的下一个剂量水平 --
-- 迄今为止没有观察到剂量限制性毒性(DLTs) --
-- 迄今为止没有观察到皮疹 --
迈阿密,2024年11月20日(环球新闻通讯社) -- Pasithea Therapeutics Corp。 (纳斯达克: KTTA)(“Pasithea”或“公司”),是一家临床阶段的生物技术公司,正在开发PAS-004,一种用于治疗神经纤维瘤病1型(NF1)和其他癌症指示的下一代大环MEk抑制剂,今天宣布外部安全审查委员会建议无修改地继续进行第4组,15mg胶囊。此建议是基于没有任何剂量限制毒性(DLT’s)的情况下做出的。此外,在接受PAS-004的前9名患者中没有观察到皮疹。公司决定在试验中增加一个40亿组,包含3名额外患者,并引入一种用于商业用途的替代配方。
Pasithea首席执行官Tiago Reis Marques博士表示:“我们很高兴地观察到,随着我们继续增加剂量,目前尚未看到皮疹出现。皮疹是使用竞争者MEk抑制剂时在低剂量下观察到的常见不良事件(AE),可能导致实际操作中的高停药率。此外,我们对使用我们潜在的商业配方给患者用药感到兴奋。”
该1期临床试验是一项多中心、开放标签、剂量递增的3+3研究设计,旨在评估PAS-004在具有记录在案的RAS、NF1或RAF突变的MAPk通路驱动的晚期实体瘤患者中的安全性、耐受性、药代动力学(PK)、药效学(PD)和初步疗效(NCT06299839)。
PAS-004展示了一种不同的MEk抑制剂特性
与需要每日两次给药(买盘)且显示短半衰期(<8小时)的NF1一代MEk抑制剂不同,PAS-004有潜力实现延长的靶向抑制和每日一次给药(QD),因其半衰期约为70小时。如前所述,Pk曲线显示在稳态时血浆水平一致,由低Cmax与Cmin比率反映,可能降低与Cmax相关的毒性风险。这些发现为PAS-004进入临床试验提供了令人信服的理由,既用于治疗NF1中的皮肤和丛状神经纤维瘤,也用于癌症和其他MAPk驱动的机会。公司预计将在试验进展中定期提供更多试验更新。
关于Pasithea Therapeutics Corp。
Pasithea是一家专注于中枢神经系统(CNS)疾病和RAS病的创新型治疗方法的生物技术公司。Pasithea拥有一支由神经科学、转化医学和药物开发领域的专家组成的经验丰富的团队,正开发用于治疗神经瘤1型(NF1)、实体瘤和肌萎缩性脊髓侧索硬化症(ALS)的新型分子实体。
前瞻性声明
本新闻稿包含根据1995年私人证券诉讼改革法案的安全港条款所作的构成“前瞻性陈述”的声明。这些前瞻性陈述包括有关公司正在进行的第一阶段临床试验及PAS-004的安全性、耐受性、药物代谢动力学(PK)和初步疗效的声明,以及除历史事实声明以外的所有其他声明,涉及公司对其业务未来事件的当前观点和假设,以及其他关于公司计划、假设、期望、信念和目标、公司当前及未来业务策略的成功、产品开发、临床前研究、临床研究、临床和监管时间表、市场机会、竞争地位、商业策略、潜在增长机会及其他性质上具有预测性的声明。前瞻性陈述受到许多条件的影响,其中许多超出公司的控制范围。虽然公司认为这些前瞻性陈述是合理的,但不应对任何此类前瞻性陈述给予过度依赖,这些陈述基于公司在本发布之日获得的信息。这些前瞻性陈述基于当前的估计和假设,并面临各种风险和不确定性,包括未来临床试验结果可能与迄今观察到的结果不符,可能是负面或模糊的,或者可能达不到监管批准所需的统计显著性水平的风险,以及在公司最近的10-K表格年度报告、10-Q表格季度报告和其他向美国证券交易委员会(SEC)提交的文件中列出的其他因素。因此,实际结果可能会有重大不同。公司不承担在本发布日期之后就新信息、未来事件或其他情况更新这些陈述的义务,除非法律要求。
Pasithea Therapeutics联系方式
Patrick Gaynes
企业通讯
pgaynes@pasithea.com