PharmAla Biotech Holdings (CSE: MDMA) (OTC:PMBHF), a Vancouver-based biotechnology company specializing in the research of MDMA and other MDXX class molecules, has recently received important guidance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The company announced Thursday that following pre-submission meetings held earlier this year, the MHRA has confirmed that PharmAla’s MDMA-like drug candidate ALA-002 does not require additional preclinical data before proceeding with clinical trials.
Following the guidance, PharmAla has partnered with the University of Sydney, led by Dr. Adam Guastella, to launch a clinical program focused on exploring the potential of ALA-002 as a treatment for fear disorders and social anxiety in Autism patients.
“While this result took a bit longer to receive than we anticipated, it did conform with our expectations,” PharmAla Biotech Vice President of Research Harpreet Kaur said.
“We are now prepared to move into the clinical phase of ALA-002’s development with full confidence that we have a range of competent and well-regulated jurisdictions to choose from. Our intent is to move rapidly, with the expectation of moving into a Phase 2 trial.”
Company stock went up by 9.68 per cent to $0.34 on the Canadian Securities Exchange.
Read more: PharmAla Biotech secures first purchase order for GMP LaNeo MDMA in Australia
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ALA-002 is a trademarked, novel compound belonging to the MDXX class of molecules, which includes MDMA. ALA-002 is currently undergoing clinical development to evaluate its potential as a therapeutic treatment. It is being studied for various indications, including fear disorders and social anxiety in Autism patients. As a promising drug candidate, ALA-002 is expected to undergo further trials to assess its safety and efficacy.
“Dr. Guastella is highly expert in the specific area of research in which we wish to engage, and we are very pleased to formalize our relationship with him – and to continue deepening our ties to Australia,” said Nick Kadysh, CEO, PharmAla Biotech.
“We believe that ALA-002 represents one of PharmAla’s most promising IP assets.”
Kadysh added that not only is it viable as a treatment for fear disorders – much like generic MDMA – but with its improved toxicology, the company is hopeful that clinical trials will bear out its viability for treating another “orphan indication.”
Last July, PharmAla confirmed its first purchase order for GMP LaNeo MDMA from Cortexa, its joint venture with Australian company Vitura Health (ASX:VIT). The order includes both finished capsule and raw API forms of the compound.
The company announced in April that Incannex Healthcare Ltd (ASX: IHL) (NASDAQ: IXHL) will be using its MDMA at Incannex psychedelics clinics in Australia.
In February, PharmAla signed an agreement with Emyria Limited (ASX: EMD) (ASX: EMD) to supply its LaNeo MDMA product.
