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Lykos Therapeutics Announces Completion of European Phase 2 Study for MDMA-Assisted Therapy for PTSD

Lykos Therapeutics Announces Completion of European Phase 2 Study for MDMA-Assisted Therapy for PTSD

Lykos Therapeutics宣佈完成創傷後應激障礙的****輔助療法的歐洲2期研究
PR Newswire ·  04/24 20:00

Study completion marks an important next step in the Company's Europe program

研究的完成標誌着公司歐洲項目邁出了重要的下一步

SAN JOSE, Calif., April 24, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, announced the completion of a European Phase 2 study (MP18), an open-label, multicenter feasibility study of investigational midomafetamine (MDMA) capsules used in combination with psychological intervention ("MDMA-assisted therapy") for adults with post-traumatic stress disorder ("PTSD"). Having completed the pivotal clinical Phase 3 studies in the United States, the new drug application ("NDA") for Lykos' investigational midomafetamine capsules is currently under review by the U.S. Food and Drug Administration ("FDA").

加利福尼亞州聖何塞,2024年4月24日 /PRNewswire/ — 致力於實現心理健康轉型的公司Lykos Therapeutics(前身爲MAPS公共福利公司)(“Lykos”)宣佈完成一項歐洲2期研究(MP18),這是一項開放標籤的多中心可行性研究,用於研究性米多馬非他明(MDMA)膠囊與成人心理干預(“****輔助療法”)聯合使用患有創傷後應激障礙(“PTSD”)。在美國完成了關鍵的3期臨床研究後,Lykos的研究性米多馬非他明膠囊的新藥申請(“NDA”)目前正在接受美國食品藥品監督管理局(“FDA”)的審查。

"Given the substantial need for new treatment options for individuals with mental health conditions in Europe, the completion of this Phase 2 study is an important step to helping address unmet needs outside the United States," said Amy Emerson, chief executive officer at Lykos Therapeutics. "By pursuing FDA approval of MDMA-assisted therapy first, we believe the learnings will be beneficial as we determine our regulatory strategy in the United Kingdom and Europe. We are exploring different avenues to bring MDMA-assisted therapy to market outside the United States."

Lykos Therapeutics首席執行官艾米·艾默生表示:“鑑於歐洲精神健康問題患者對新的治療選擇的巨大需求,這項2期研究的完成是幫助解決美國以外未滿足需求的重要一步。”“通過首先爭取美國食品藥品管理局批准****輔助療法,我們相信在我們確定英國和歐洲的監管戰略時,這些經驗將是有益的。我們正在探索不同的途徑,將****輔助療法推向美國以外的市場。”

The study included twenty-one participants treated in sites in the Netherlands, United Kingdom, Czech Republic, Germany, and Norway. The study included an optional fMRI sub-study assessing changes in brain activity in subjects with PTSD.

該研究包括在荷蘭、英國、捷克共和國、德國和挪威等地接受治療的21名參與者。該研究包括一項可選的功能磁共振成像子研究,評估創傷後應激障礙受試者的大腦活動變化。

"Successful completion of this Phase 2 study in Europe is an important step to build on the body of evidence evaluating the efficacy and safety of MDMA-assisted therapy in the United States where this novel therapeutic approach now is under FDA review," said Eric Vermetten, professor of psychiatry at Leiden University Medical Center and lead investigator of the study. "There is an urgent need for new and effective evidence-based treatments for PTSD in Europe where the reported PTSD prevalence is up to 6.7%."1

On February 9, 2024, the FDA accepted the company's NDA for midomafetamine (MDMA) capsules used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with PTSD. The FDA granted the application Priority Review and has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024. The FDA grants Priority Review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.2 If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.

萊頓大學醫學中心精神病學教授、該研究的首席研究員埃裏克·維梅滕說:“在歐洲成功完成這項2期研究是建立在美國評估****輔助療法療效和安全性的證據基礎上的重要一步,這種新的治療方法目前正在接受美國食品藥品管理局的審查。”“歐洲報告的創傷後應激障礙患病率高達6.7%,迫切需要新的和有效的循證治療方法。”1

2024年2月9日,美國食品藥品管理局接受了該公司對與心理干預聯合使用的米多馬非他明(MDMA)膠囊的保密協議,其中包括由合格的醫療保健提供者爲創傷後應激障礙患者提供的心理治療(談話療法)和其他支持服務。美國食品藥品管理局批准了該申請的優先審查,並將《處方藥使用者費用法》(“PDUFA”)的目標行動日期定爲2024年8月11日。與標準應用相比,如果獲得批准,將顯著提高嚴重疾病的治療、診斷或預防的安全性或有效性,美國食品和藥物管理局對這些藥物給予優先審查。2 如果獲得批准,這將是第一種****輔助療法和迷幻輔助療法。

Midomafetamine (MDMA) capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD. Investigational midomafetamine is also being studied in other indications.

Lykos Therapeutics (Formerly MAPS PBC)
At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental healthcare. We're applying our decades in evidence-based research to develop investigational psychedelics to catalyze therapeutic approaches for mental health conditions. We are relentlessly exploring and reimagining novel approaches to address unmet needs in the mental healthcare space, with an initial focus on PTSD. As a PBC, we are focused on delivering positive impact on our people, communities and society. To learn more visit us at and on LinkedIn, X, Instagram and Facebook.

1 Burri A, Maercker A. Differences in prevalence rates of PTSD in various European countries explained by war exposure, other trauma and cultural value orientation. BMC Res Notes. 2014;7:407. doi: 10.1186/1756-0500-7-407

米多馬非他明(MDMA)膠囊尚未獲得任何監管機構的批准。尚未確定米多馬非他明治療創傷後應激障礙的安全性和有效性。研究中的米多馬非他明在其他適應症中也在研究中。

Lykos Therapeutics(原名 MAPS PBC
在由MAPS創立的公益公司(PBC)Lykos Therapeutics,我們的使命是改變心理保健。我們正在運用數十年的循證研究來開發研究性迷幻藥物,以催化心理健康狀況的治療方法。我們正在不懈地探索和重新構想解決心理健康領域未滿足需求的新方法,最初的重點是創傷後應激障礙。作爲PBC,我們致力於爲我們的人民、社區和社會帶來積極影響。要了解更多信息,請訪問我們的領英、X、Instagram和臉書。

1 Burri A、Maercker A. 戰爭暴露、其他創傷和文化價值取向可以解釋歐洲各國創傷後應激障礙患病率的差異。 BMC 研究筆記. 2014; 7:407. doi: 10.1186/1756-0500-7-407

2 FDA Priority Review. Available at: Accessed January 2024.

2 FDA 優先審查。可在以下網址獲得:2024 年 1 月訪問。

SOURCE Lykos Therapeutics

來源 Lykos 療法

譯文內容由第三人軟體翻譯。


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