ASX Health Stocks: Psilocybin drug shows promise for fibromyalgia pain relief

Tryptamine’s psilocybin trial indicates potential for treating fibromyalgia
Actinogen says Xanamem eases depression but misses cognitive goals
PYC reports vision gains using experimental eye drug

Tryptamine’s Phase 2a trial shows promise for fibromyalgia

Tryptamine Therapeutics (ASX:TYP) has shared promising results from its Phase 2a clinical trial on fibromyalgia, conducted with the University of Michigan and presented at the IASP 2024 World Congress on Pain.

Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain, fatigue, and other symptoms such as sleep disturbances and cognitive difficulties.

The trial involved patients taking TRP-8802, an oral psilocybin formulation, along with psychotherapy.

Every patient in the study reported improvements in pain, sleep, and overall quality of life one month after treatment. They also experienced reductions in anxiety and enhanced cognitive abilities, with one patient noting an unexpected return of their sense of smell after a past COVID-19 infection.

These results not only highlight the potential of psychedelic-assisted therapy for fibromyalgia, a condition with limited treatment options, but also strengthen Tryptamine’s intellectual property and clinical trial strategy.

The company now plans to build on this success with a Phase 2 trial of TRP-8803, an intravenous psilocin treatment, set to begin in early 2025.

Actinogen’s drug eases depression but misses primary endpoint

Actinogen Medical (ASX:ACW) has reported that its Phase 2a XanaCIDD trial for Xanamem demonstrated significant benefits in treating depression, despite not meeting the primary goal related to cognitive attention.

The trial found that Xanamem led to a clinically meaningful and statistically significant reduction in depression symptoms, measured by the MADRS scale.

Improvements were notable both at the end of the six-week treatment period and four weeks afterward.

However, the trial did not achieve its primary endpoint of enhancing cognitive attention, as measured by the “Attention Composite” of three Cogstate computerised tests.

Both Xanamem and placebo groups showed large improvements, which may have diluted the ability to detect any specific benefits of Xanamem on cognitive function.

The unexpectedly large improvement in the placebo group might also have affected the results, says the Actinogen.

The trial results, however, indicate that Xanamem was safe and well-tolerated, with a promising safety profile consistent with previous studies.

Particularly encouraging was the finding that Xanamem provided greater benefits to patients with less severe depression, showing a significant improvement in MADRS scores both at the end of treatment and four weeks later.

Additionally, patients who took Xanamem as a standalone therapy, without other antidepressants, experienced clinically significant improvements at the end of treatment.

Moving forward, ACW says further exploration will focus on understanding the promising results in specific patient groups and refining future trials.

“The excellent safety profile of Xanamem was again demonstrated in this trial, and the significant treatment benefits seen in depression are encouraging for both the depression and Alzheimer’s disease programs,” said Actinogen’s CEO, Dr Steven Gourlay.

Promising vision improvements in PYC’s severe eye disease trials

PYC Therapeutics (ASX:PYC) has announced encouraging progress with its investigational drug VP-001, designed to treat Retinitis Pigmentosa type 11 (RP11), a severe genetic eye disorder.

The company recently reported that two patients receiving a 75-microgram dose of VP-001 showed significant improvements in vision.

This follows earlier results where two other patients improved after receiving a 30-microgram dose of the same drug.

The latest data reveal that these two patients experienced notable enhancements in retinal sensitivity, which is crucial for central vision and detailed visual perception.

Specifically, both patients had improved retinal sensitivity across the macula – the area of the retina responsible for sharp central vision – at the three-month follow-up.

For instance, one patient had a 1.1 dB increase in retinal sensitivity in the treated eye compared to baseline, while another had a 1.0 dB improvement. These improvements were observed to be better than changes seen in the untreated eyes of the same patients.

However, not all results were positive.

One patient, who carries mutations in two different genes associated with RP11, did not show any improvement and instead experienced disease progression in both eyes. Despite this, all three patients from this cohort have enrolled in a follow-up study to receive multiple doses of VP-001.

PYC is continuing to gather data from patients in both the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.

The results from these studies will help establish clinical proof of concept for VP-001.

The company anticipates further data later in the year and is preparing to launch a larger registrational trial in 2025.

Neurotech targets global deals

Meanwhile, Neurotech International (ASX:NTI), is focusing on securing global partnerships and advancing registration efforts for its drug, NTI164, which targets pediatric neurological disorders.

The company plans to form strategic alliances in the US, Europe, and select Asian regions to support the clinical development, regulatory approval, manufacturing, and eventual market launch of NTI164.

In Australia, Neurotech will pursue multiple registration pathways, including provisional registration through the Therapeutic Goods Administration (TGA), leveraging the strong clinical evidence and safety data it has accumulated.

Additionally, Neurotech is committed to completing FDA-required studies, including toxicity and human pharmacokinetic trials, to secure Investigational New Drug (IND) approval.

The goal is to initiate clinical trials for NTI164 in at least one neurological disorder, such as Rett Syndrome, Autism Spectrum Disorder (ASD), or PANDAS/PANS.

This strategy is expected to enhance the value of Neurotech and reduce financial, clinical, and regulatory risks for shareholders.

At Stockhead we tell it like it is. While Neurotech International is a Stockhead advertiser, it did not sponsor this article.