Psychedelics company Tryp Therapeutics Inc. (OTCQB:TRYPF) and Harvard's largest medical teaching facility, the Massachusetts General Hospital (MGH) have inked a Letter of Intent (LOI) to fund and conduct a Phase 2a clinical trial assessing the effects of psilocybin-assisted psychotherapy in the treatment of adult patients with Irritable Bowel Syndrome (IBS.)
Tryp is a clinical-stage biotech company developing IV-infused therapies based on the magic mushroom components for a variety of health conditions with unmet medical needs as is the case with IBS - a common, chronic and often debilitating condition affecting almost 4-5% of the total population. A large number of IBS sufferers find no relief in current treatments.
The planned study will evaluate the effect of psilocybin-assisted therapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms, while fibromyalgia, anxiety and fatigue are also commonly associated health conditions.
The study's primary efficacy endpoint will be the improvement in abdominal pain and will also regard and compare other data such as changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post-session.
Dr. Erin Mauney, pediatric gastroenterology fellow at Mass General and the trial's PI, says there is "tremendous potential" for the treatment of debilitating IBS and other gut-brain interaction disorders via the combined administration of psilocybin and psychotherapy.
The new trial will examine how this combination may alter important brain networks involved in chronic pain and gastrointestinal-specific anxiety in IBS to "bolster the neural flexibility in these patients and thereby reduce visceral hypersensitivity," Mauney added.
On behalf of Tryp, CEO Dr. Jim Gilligan said, "MGH is an ideal partner for Tryp to expand on its strategy of utilizing oral psilocybin TRP-8802 to explore the clinical potential of psilocybin-assisted psychotherapy in new indications."
The new agreement sets the stage for the company to submit the IND clinical trial application. If granted, and should the study deliver positive outcomes, Tryp would continue clinical development for IBS with the company's proprietary IV-infused psilocin formulation, TRP-8803.
According to Gilligan, this route "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 time frame."
Photo: Darko Djurin from Pixabay
迷幻药公司Tryp Treateutics Inc.(场外交易市场代码:TRYPF)和哈佛大学最大的医学教学机构--马萨诸塞州总医院(MGH)签署了一份意向书,资助并进行一项2a期临床试验,评估裸盖菇素辅助心理疗法对成年肠易激综合征(IBS)患者的治疗效果。
Tryp是一家临床阶段的生物技术公司,开发基于神奇蘑菇成分的静脉输注疗法,适用于各种健康状况,但仍有未得到满足的医疗需求,就像IBS-一种常见的慢性疾病,通常会使人虚弱,几乎影响到总人口的4%-5%。大量IBS患者在目前的治疗中找不到缓解的办法。
这项计划中的研究将评估裸盖菇素辅助治疗对经历慢性腹痛和其他衰弱胃肠道症状的难治性肠易激综合征患者的效果,同时纤维肌痛、焦虑和疲劳也通常与健康状况相关。
这项研究的主要疗效终点将是腹痛的改善,还将考虑和比较其他数据,如基线和疗程后4周、6个月和12个月的大脑连接和对疼痛的反应的变化。
麻省总医院的儿科胃肠病研究员、试验的PI Erin Mauney博士说,通过联合使用裸盖菇素和心理疗法,治疗虚弱的IBS和其他肠道-大脑相互作用障碍的可能性很大。
Mauney补充说,这项新的试验将研究这种组合如何改变IBS中涉及慢性疼痛和胃肠道特异性焦虑的重要大脑网络,以“增强这些患者的神经灵活性,从而降低内脏超敏反应”。
代表Tryp的首席执行官Jim Gilligan博士说:“MGH是Tryp扩大其利用口服裸盖菇素TRP-8802来探索裸盖菇素辅助心理疗法在新适应症中的临床潜力的战略的理想合作伙伴。”
新协议为该公司提交IND临床试验申请奠定了基础。如果获得批准,如果这项研究产生了积极的结果,Tryp将继续使用该公司专有的静脉注射裸鼠毒素制剂Trp-8803进行IBS的临床开发。
根据Gilligan的说法,这条路线“缓解了口服裸盖菇素的许多缺点,包括显著缩短致幻状态开始的时间,控制迷幻体验的深度和持续时间,并将干预的总持续时间缩短到商业上可行的时间框架。”
图片来源:来自Pixabay的Darko Djuin