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Psilocybin For IBS Gets FDA Nod To Begin Clinical Trials At Mass. General Hospital

Psilocybin For IBS Gets FDA Nod To Begin Clinical Trials At Mass. General Hospital

用於腸易激綜合徵的 psilocybin 獲得 FDA 批准,開始大規模臨床試驗綜合醫院
Benzinga ·  2023/07/13 15:48

Tryp Therapeutics' (OTCQB:TRYPF) latest Investigational New Drug (IND) application was approved by the FDA, enabling the company to begin Phase 2a clinical trials at the Massachusetts General Hospital (MGH) on the effects of psilocybin-assisted psychotherapy for adults with Irritable Bowel Syndrome (IBS).

Tryp治療公司(場外交易代碼:TRYPF)FDA批准了最新的研究新藥(IND)申請,使該公司能夠在馬薩諸塞州總醫院(MGH)開始2a期臨床試驗,研究裸蓋菇素輔助心理療法對成人腸易激綜合徵(IBS)的影響。

The clinical-stage biotech company is focused on developing novel IV-infused psilocin treatments. Its lead psilocin compound TRP-8803 is currently being assessed in a Phase 2a trial for the treatment of binge eating disorder at the University of Florida where an interim analysis reportedly showed an average reduction of +80% in binge eating episodes.

這家臨床階段的生物技術公司專注於開發新型靜脈注射裸鼠毒素療法。它的主要裸子植物素類化合物Trp-8803目前正在佛羅裡達大學進行2a期試驗,用於治療暴飲暴食障礙,據報道,中期分析顯示暴飲暴食發作的平均減少+80%。

Meanwhile, its synthetic oral psilocybin, TRP-8802, is set to be studied in a Phase 2a trial with the University of Michigan for the treatment of fibromyalgia, as well as in the recently-approved Phase 2a study assessing its effects in patients with treatment-resistant IBS experiencing chronic abdominal pain and other gastrointestinal symptoms while also potentially suffering from fibromyalgia, anxiety and fatigue.

與此同時,它的合成口服裸蓋菇素Trp-8802將在密歇根大學進行的治療纖維肌痛的2a階段試驗中進行研究,以及最近獲得批准的2a階段研究,評估其對經歷慢性腹痛和其他胃腸道癥狀,同時可能患有纖維肌痛、焦慮和疲勞的患者的療效。

The trial's primary efficacy endpoint is the improvement in abdominal pain, measured at four weeks after the last monitored drug administration. Secondary endpoints include changes in brain connectivity.

該試驗的主要療效終點是腹痛的改善,在最後一次監測給藥後四周測量。次要終點包括大腦連接性的變化。

"Research indicates a possibility for addressing IBS and other disorders of gut-brain interaction using a combined approach of psilocybin and psychotherapy," said MGH physician and study PI Dr. Erin Mauney, who added that the team is wrapping up preparations to begin patient enrollment.

MGH內科醫生兼研究PI Erin Mauney博士說,研究表明,使用裸蓋菇素和心理治療的組合方法,有可能解決IBS和其他腸道-大腦相互作用障礙。他補充說,該團隊正在完成準備工作,開始招募患者。

Tryp's CEO Dr. Jim Gilligan says the Phase 2a study with Harvard Medical School/MGH for IBS represents a major milestone for the company's clinical programs and that the novel therapeutic approach holds "great promise" for IBS patients, especially in view of the few existing options.

Tryp的首席執行官吉姆·吉利根博士說,與哈佛醫學院/麻省理工學院合作進行的IBS 2a期研究是該公司臨床計劃的一個重要里程碑,這種新的治療方法對IBS患者來說前景廣闊,特別是考慮到現有的選擇寥寥無幾。

Benzinga is all in for psychedelics and cannabis. Our upcoming 17th CCC edition will take place in Chicago, Sept 27-28.

本辛加對迷幻劑和大麻都很感興趣。我們即將舉行的第17屆CCC大會將於9月27日至28日在芝加哥舉行。

This is the place to get DEALS DONE. So join us by getting your tickets today, before prices increase. Secure yourself a spot at the EPICENTER of cannabis investment and branding!

這是達成交易的地方。所以,在票價上漲之前,今天就加入我們的行列,拿到門票吧。確保自己在大麻投資和品牌推廣的震央獲得一席之地!

Photo: Benzinga edit with photo by Cannabis_Pic and Gorodenkoff and Troyan on Shutterstock.

照片:Benzinga編輯與照片由Cannabis_Pic和Gorodenkoff和Troyan on Shutterstock拍攝。

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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