PharmAla Biotech Signs Manufacturing Agreement For ALA-002 Drug Substance, Advancing Novel MDMA Therapy Toward Phase 2 Trials

PharmAla Biotech Holdings Inc., a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules, including its proprietary LaNeo MDMA, announced that its wholly owned subsidiary, PharmAla Biotech Australia, has entered into an agreement with a United Kingdom–based contract development and manufacturing organization to manufacture the drug substance for ALA-002.

The company conducted a global request-for-proposal process to identify a suitable partner for the process development and manufacturing of components for the ALA-002 drug product. According to Nick Kadysh, Founding Chief Executive Officer of PharmAla Biotech, this agreement represents an important step toward the planned Phase 2 clinical trial of ALA-002, which is expected to begin in 2026. He also noted that this marks the first time since 2022 that PharmAla will be developing a completely new active pharmaceutical ingredient intended for human use.

ALA-002 is PharmAla’s patented, novel, non-racemic MDMA formulation. The company has previously announced plans to initiate Phase 2a and Phase 2b clinical studies in 2026 to evaluate the formulation for the treatment of social anxiety disorder. Due to the controlled-substance nature of ALA-002, PharmAla has chosen not to disclose the name of the contract manufacturing partner at the request of the organization.

In a separate update, PharmAla also confirmed the completion of one of two planned shipments of its LaNeo MDMA product to the Parsons Research Center for Psychedelic Healing at Mount Sinai Hospital. This shipment follows the company’s earlier announcement in October 2024 and will be used to support ongoing clinical research activities at the center.