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Tryp Therapeutics Submits Investigational New Drug (IND) Application to US FDA for Planned Phase 2a Clinical Trial in Patients With IBS at Massachusetts General Hospital

Tryp Therapeutics Submits Investigational New Drug (IND) Application to US FDA for Planned Phase 2a Clinical Trial in Patients With IBS at Massachusetts General Hospital

Tryp Therapeutics向美國食品藥品管理局提交研究性新藥(IND)申請,計劃在馬薩諸塞州綜合醫院對腸易激綜合徵患者進行2a期臨床試驗
Accesswire ·  2023/05/24 18:00

KELOWNA, BC / ACCESSWIRE / May 24, 2023 / Tryp Therapeutics, Inc. (CSE:TRYP)(OTCQB:TRYPF) ("Tryp" or the "Company"), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs, today announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).

卑詩省基洛納/ACCESSWIRE/2023年5月24日/Tryp治療公司致力於開發靜脈注射裸蓋菇素(裸蓋菇素的活性代謝物)的臨床階段生物技術公司(CSE:TRYP)(場外交易代碼:TRYPF)(以下簡稱“公司”)今天宣佈,該公司已向美國食品和藥物管理局(FDA)提交了一份新藥研究(IND)申請,計劃在馬薩諸塞州總醫院(MGH)進行2a期臨床試驗,調查裸蓋菇素輔助心理療法對21歲以上腸易激綜合徵(IBS)患者的治療效果。

The planned open label study in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints.

這項計劃與哈佛醫學院/馬薩諸塞州總醫院合作的開放標籤研究將評估裸蓋菇素輔助心理療法對經歷慢性腹痛和其他衰弱胃腸道癥狀的難治性腸易激綜合徵患者的效果。這些患者中的許多人還患有纖維肌痛、焦慮和疲勞。這項研究的主要療效終點將是改善腹痛。這項擬議的研究還將探索在基線以及迷幻藥物治療後4周、6個月和12個月以及許多其他次要終點時大腦連接性和疼痛反應的變化。

In recognition of this important development, Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics, said, "Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program."

Tryp治療公司首席執行官吉姆·吉利根博士表示,認識到這一重要進展,Tryp和我們在哈佛/麻省理工學院的合作者相信,通過聯合使用裸蓋菇素和心理療法來治療虛弱的IBS癥狀具有巨大的潛力。這項臨床研究將檢驗裸蓋菇素輔助的心理療法如何改變IBS患者的慢性腹痛和胃腸道特異性焦慮的大腦網路,以改善他們的癥狀。提交IND 163994是推進我們計劃的重要一步。

About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp's lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience. For more information, please visit .

關於Tryp Treateutics
Tryp Treateutics是一家臨床階段的生物技術公司,專注於開發專有的新配方,用於給藥與心理療法相結合,以治療有未得到滿足的醫療需求的疾病。Tryp的Lead計劃TRP-8803是靜脈注射裸蓋菇素(裸蓋菇素的活性代謝物)的專利配方,可以緩解口服裸蓋菇素的許多缺點,包括:顯著縮短致幻狀態開始的時間,控制迷幻體驗的深度和持續時間,並將幹預的總持續時間減少到商業上可行的時間框架。該公司在佛羅裡達大學有正在進行的治療暴飲暴食障礙的2a階段臨床試驗,即將與密歇根大學進行的治療纖維肌痛的2a階段臨床試驗,以及計劃在馬薩諸塞州綜合醫院進行的治療腸易激綜合徵的2a階段試驗,所有這些試驗都在使用TRP-8802(合成的口服裸蓋菇素)來證明在這些適應症中的療效。在初步的臨床益處已經被證明的地方,後續的研究有望利用Trp-8803(靜脈輸注的psiLocin),它有可能進一步改善療效、安全性和患者體驗。欲瞭解更多資訊,請訪問。

Investor & Media Contact
Peter Molloy
Chief Business Officer
Tryp Therapeutics
pmolloy@tryptherapeutics.com

投資者和媒體聯繫方式
彼得·莫洛伊
首席商務官
Tryp治療公司
郵箱:pmolloy@trypTreateutics.com

Forward-Looking Information
Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans," "targets," "expects" or "does not expect," "is expected," "an opportunity exists," "is positioned," "estimates," "intends," "assumes," "anticipates" or "does not anticipate" or "believes," or variations of such words and phrases or state that certain actions, events or results "may," "could," "would," "might," "will" or "will be taken," "occur" or "be achieved." In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events.

前瞻性資訊
本新聞稿中的某些資訊屬於前瞻性資訊。在一些情況下,但不一定是在所有情況下,前瞻性資訊可以通過使用前瞻性術語來識別,所述前瞻性術語諸如“計劃”、“目標”、“預期”或“不預期”、“預期”、“機會存在”、“定位”、“估計”、“打算”、“假設”、“預期”或“不預期”或“相信”,或這些詞語和短語的變體或陳述某些行動、事件或結果“可能”、“可能”、“假設”、“預期”或“不預期”或“相信”等詞語和短語的變體或陳述某些行動、事件或結果“可能”、“可能”、““將”、“可能”、“將”或“將被採取”、“發生”或“將被實現”。此外,任何提及對未來事件或情況的預期、預測或其他描述的陳述都包含前瞻性資訊。含有前瞻性資訊的陳述不是歷史事實,而是代表管理層對未來事件的期望、估計和預測。

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the "Risk Factors'' section of Tryp's final prospectus available at . These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

前瞻性資訊必須基於許多意見、假設和估計,儘管Tryp在本新聞稿發佈之日認為這些意見、假設和估計是合理的,但這些意見、假設和估計會受到已知和未知的風險、不確定性、假設和其他因素的影響,這些因素可能會導致實際結果、活動水準、業績或成就與此類前瞻性資訊明示或暗示的結果、活動水準、業績或成就大不相同,包括但不限於Tryp最終招股說明書的“風險因素”部分更詳細地描述的因素,這些因素可在 。這些因素並不是可能影響Tryp的因素的完整列表;但是,應該仔細考慮這些因素。不能保證這樣的估計和假設將被證明是正確的。本新聞稿中包含的前瞻性陳述是截至本新聞稿發佈之日作出的,Tryp明確表示不承擔任何義務來更新或更改包含任何前瞻性資訊或其背後的因素或假設的陳述,無論是由於新資訊、未來事件還是其他原因,除非法律要求。

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

加拿大證券交易所及其監管服務提供商均未對本新聞稿的充分性或準確性進行審查或承擔責任。

SOURCE: Tryp Therapeutics

資料來源:Tryp治療公司


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