PharmAla Biotech Holdings Inc has announced that its wholly-owned subsidiary, PharmAla Biotech Australia, has contracted with a UK-based CDMO to manufacture its ALA-002 drug substance.

“PharmAla Australia worked diligently, executing a global RFP search to find our ideal partner for process development and manufacturing of the ALA-002 drug product components. This is an important and necessary step to us executing our ALA-002 Phase 2 clinical trial in 2026, and the first time since 2022 that PharmAla will be developing a wholly new Active Pharmaceutical Ingredient for human use,” said Nick Kadysh, Founding CEO, PharmAla Biotech.

ALA-002 is PharmAla’s patented, novel, non-racemic MDMA formulation. PharmAla has publicly announced that it will be initiating phase 2a/2b clinical research into the formulation exploring Social Anxiety Disorder in 2026. Due to the nature of ALA-002 as a controlled substance, PharmAla is not publicly disclosing the name of the CDMO at their request.

Pursuant to the announcement made on 21 October, 2024, PharmAla has also announced that the company has completed one of two contracted shipments of LaNeo MDMA to the Parsons Research Centre for Psychedelic Healing at Mount Sinai. The material is scheduled to be used in clinical research.