• 80% of participants have total remission from PTSD following two doses of Lucenex in Phase II trial
  • 50% reduction in anxiety scores and 57% decrease in depression scores from baseline to day 44 of treatment
  • Preliminary results to be used in ongoing discussions with potential partners and collaborators

 

Melodiol Global Health’s wholly-owned psychedelics subsidiary Halucenex Life Sciences Inc has achieved encouraging results in its Phase II clinical trial to test the efficacy of psilocybin on treatment-resistant Post Traumatic Stress Disorder (PTSD).

The emerging data demonstrates that Halucenex’s psilocybin product offers a compelling  and  potentially life-altering treatment path for people living with the repercussions of PTSD.   

Melodiol Global Health (ASX:ME1) says five patients have undergone testing to date with 80% of participants experiencing total remission from PTSD symptoms following two doses of Halucenex’s 100%-owned synthetic psilocybin aqueous solution Lucenex. 

Additional results from first five patients include:

  • 50% reduction in anxiety scores from baseline to day 44 of treatment
  • 57% reduction in depression scores from baseline to day 44 of treatment

ME1 says the initial results are very pleasing given conventional treatments for anxiety and depression are only around 20-30% effective.

In further positive results upon review of the preliminary data, it was noted that three of the five trial participants that scored in a moderate to severe range for depression had reduced to a normal range by day 44 of treatment.

 

Single-arm, open-lab trial

The trial, which commenced in December 2022 is a single-arm, open-lab  trial  to  test  the  efficacy of psilocybin on treatment resistant PTSD symptoms.

The  trial use Halucenex’s 100%-owned and formulated synthetic psilocybin aqueous solution Lucenex, in both 10mg and 25mg formats which is being delivered to 20 respective patients on separate occasions in a micro dose and  macro dose format.

To date, the company has administered both micro and macro doses to 5 patients, which has allowed for preliminary results.

Halucenex will continue to advance first dosages with another 15 trial candidates over the coming months, providing additional opportunity for validation of Halucenex’s potential.  

 

Future opportunities for ME1

The results represent a major achievement for ME1 and have the potential to unlock future commercial opportunities for the company.

The company will use its preliminary results in ongoing discussions with potential partners and collaborators, which is expected to unlock near term revenue generating opportunities for the business division.

CEO and managing director William Lay says results from the first five patients that have undergone psilocybin dosage, using our unique Lucenex solution are “nothing short of exceptional”.

“A remission rate of 80% by day 44 of treatment provides considerable validation of Halucenex’s approach and potential as a viable treatment option for patients suffering from treatment-resistant PTSD symptoms,” he says.“As trial initiatives continue, another 15 patients will undergo treatment.

“This has the potential to provide additional data which can be leveraged in discussions with potential partners and for the future commercial application of our products.

Paige Stevens, Halucenex’s Clinical Trial Technician she was encouraged by the early results of the Phase II trial.

“I’m very pleased to be part of this project, encouraged by the early results, and excited to see the project through to completion.”

Halucenex’s Clinical Research Director Dr Lisa Batten said having worked with treatment-resistant mental health disorders her entire career I’ve seen first-hand the devastating impact of these conditions and the frustrations from lack of effective treatment options.

“Our psilocybin research shows evidence of an intervention that rapidly treats the underlying pathology rather than offering temporary solutions to get people through their days,” Batten says.

“It’s an exciting prospect to see someone get their life back.”

The trial results from Halucenex continue the good news for ME1 subsidiaries. The company announced earlier this week record sales delivered its wholly-owned Canadian subsidiary Mernova its third consecutive quarter of revenue growth.

 

This article was developed in collaboration with Melodiol Global Health, a Stockhead advertiser at the time of publishing.

 This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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