Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has fielded strong results from a Phase 2a fibromyalgia trial testing oral psilocybin formulation TRP-8802 in conjunction with psychotherapy, achieving improvements in fibromyalgia pain severity, sleep, pain interference and at least three other endpoints in all five patients.
The results were presented at the IASP 2024 World Congress on Pain in the Netherlands last week.
Difficult-to-treat condition
Fibromyalgia is a widespread disorder that causes musculoskeletal pain, fatigue, sleep and cognitive disruption and issues with mental health and mood.
As many as 1 million Australians – accounting for 3-5% of the population – suffer from fibromyalgia, living with the daily pain, brain fog and fatigue that characterise the disease.
“We are very excited about the results from the Phase 2a clinical trial in collaboration with the University of Michigan,” Tryptamine CEO Jason Carroll said.
“Fibromyalgia is a complex and widespread condition, impacting one million Australians, and imposes a large emotional, physical and economic burden on every sufferer," he said.
“Despite this, fibromyalgia sufferers have very limited success with current treatments, often resort to the use of opioids and many of these have highly limiting and wide-ranging side effects associated with their use.”
Pathway to meaningful treatment
results indicate clinically meaningful improvements in quality-of-life measures such as sleep, physical activity and the ability to participate in daily social activities, while also improving anxiety and cognitive abilities in four of five patients dosed.
TYP trial changes in pain severity, sleep disturbance and pain interference data:
One patient also reported their sense of smell had returned after losing it during a COVID-19 infection in 2021.
“While still early, these results highlight that psychedelic-assisted therapy may achieve an improved patient outcome through treating the cause of fibromyalgia rather than the limited relief to select symptoms provided from the treatment choices presently open to them,” Carroll continued.
“Through this trial, we have demonstrated that psychedelic-assisted therapy may offer an improved future for fibromyalgia patients across Australia and globally.”
Full trial results data:
More trials to come
TYP says the trial’s outcomes also strengthen the company’s intellectual property position, laying a strong foundation for future trials – planning for a Phase 2 trial is underway, expected to begin in the first half of 2024.
“On behalf of the board and management, I would like to take this opportunity to thank the research team at the University of Michigan for their ongoing involvement and their presentation at the prestigious IASP 2024 World Congress on Pain,” Carroll acknowledged.
“The presentation of these Phase 2a study results at such an event provides important exposure for Tryp’s TRP-8802 and TRP-8803 programs with key industry participants.
“Looking ahead, the company will undertake further analysis of these results in partnership with UOM researchers.
“These findings will be incorporated into planning now underway for an additional trial utilising TRP-8803, Tryp’s innovative and scalable IV-infused psilocin formulation.
“We look forward to providing further updates on trial planning in due course.”
Tryptamine is also progressing an irritable bowel syndrome trial at the Massachusetts General Hospital, where the company is about to begin Cohort 3 of a TRP-8803 Healthy Volunteer Study.