Melodiol Global Health Limited

Wholly-Owned Subsidiary Halucenex Life Sciences Inc. Achieves Remission In 80% Of First Five Patients In Phase II Clinical Trial

Melodiol Global Health Limited (ASX:ME1, FRA:1X8) (‘Melodiol’ or ‘the Company’) is pleased to advise that wholly- owned psychedelics subsidiary, Halucenex Life Sciences Inc. (‘Halucenex’) has achieved encouraging preliminary results record in the first five patients taking part in the Company’s phase II clinical trial exploring the use of psilocybin in the treatment of Post Traumatic Stress Disorder (‘PTSD’). The Company provides the following information in compliance with section 4.2 of the Code of Best Practice for Reporting by Life Science Companies (Second Edition).


Highlights:

  • Encouraging early results from Phase II clinical trial to test the efficacy of psilocybin on treatment- resistant Post Traumatic Stress Disorder (PTSD)
  • 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
  • Initial results are positive given conventional treatments for anxiety and depression are only around 20-30% effectivei
  • Results are a major achievement and have the potential to unlock future commercial opportunities for the Company
  • Initial data demonstrates that Halucenex’s psilocybin product offers a compelling and potentially life altering treatment path for people living with the repercussions of PTSD
  • Additional two patients have undergone first doses – ME1 to provide ongoing updates are results are received
  • Results from an additional 13 patients expected to be reported over the coming months, providing additional opportunity for validation of Halucenex’s potential
The trial, which commenced in December 2022 (refer ASX release 7 December 2022), is a single-arm, open- lab trial to test the efficacy of psilocybin on treatment resistant PTSD symptoms. The trial utilises 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 (refer ASX release 6 October 2022).

To date, the Company has administered both micro and macro doses to 5 patients, which has allowed for preliminary results. Initial results from the study highlighted that 80% of participants have achieved remission from treatment resistant PTSD following two doses of psilocybin. This is a major achievement for Halucenex and has the potential to unlock significant commercial opportunities for the Company.

Additionally, the five trial subjects reported on average a 57% reduction in depression scores, as well as a 50% reduction in anxiety scores from baseline by day 44 of treatment. This is very pleasing, given conventional treatments for anxiety and depression are only around 20-30% effectivei.

Further and 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.

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

Halucenex will continue to advance first dosages with another 15 trial candidates over the coming months. Additional updates will be provided to the market, as further data materialises.

Management commentary:

CEO and Managing Director, Mr William Lay said: “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.

“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. We look forward to providing additional patient results as they materialise.”

Paige Stevens, Halucenex’s Clinical Trial Technician added: “I’m very pleased to be part of this project, encouraged by the early results, and excited to see the project through to completion."

Dr Lisa Batten, Halucenex’s Clinical Research Director added: "Having worked with treatment-resistant mental health disorders my 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. It's an exciting prospect to see someone get their life back."


Click here for the full ASX Release

This article includes content from Melodial Global Health, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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