PharmAla Biotech Holdings Inc. (CSE: MDMA / OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is thrilled that – following pre-submission meetings held in Q1 of 2023 – it has received written guidance from the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA). The guidance constitutes, in part, advice that ALA-002 does not require further preclinical data in order for clinical trials to proceed.
“While this result took a bit longer to receive than we anticipated, it did conform with our expectations. 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.”
Dr. Harpreet Kaur, Vice President of Research, PharmAla Biotech
Following receipt of this guidance, PharmAla is further pleased to announce that it has entered into a clinical development agreement with the University of Sydney, under the leadership of Dr. Adam Guastella, the Michael Crouch Chair in Child and Youth Mental Health at the University.
“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. Not only is it viable as a treatment for fear disorders – much like generic MDMA – but with its improved toxicology, we are hopeful that clinical trials will bear out its viability for treating another orphan indication. PharmAla intends to treat the symptoms of social anxiety in Autism patients – we couldn’t imagine a better partner than Dr. Guastella to move forward on this exciting research.”
About PharmAla
PharmAla is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.