- PharmAla Biotech has signed an agreement with Canadian CDMO Corealis Pharma for GMP manufacturing of ALA-002 drug product for clinical supply.
- Corealis has begun research and development (R&D) on the formulation. The first GMP-manufactured batch is scheduled following completion of development activities. ALA-002 will initially be developed as a 50mg capsule.
PharmAla Biotech has signed an agreement with Corealis Pharma, a GMP-compliant contract development and manufacturing organization (CDMO) based in Laval, Québec, for the GMP manufacturing of ALA-002 drug product for clinical supply. The agreement adds a Canadian manufacturing partner to PharmAla’s supply chain for the drug candidate.
Corealis was selected following a technical, quality and regulatory evaluation of CDMOs. The company has already started R&D on the drug product formulation. GMP manufacturing of the first ALA-002 batch is scheduled to begin once development activities are complete. The product will initially be developed and launched as a 50mg capsule.
The agreement expands Corealis Pharma’s work in oral solid dosage development and manufacturing. It will support the clinical supply of ALA-002, which PharmAla is developing as part of its portfolio of MDXX-class molecules, including its proprietary LaNeo™ MDMA.
PharmAla COO Farnoud Kazemzadeh said the company was confident Corealis was the right partner for the work and welcomed the opportunity to bring the drug development activities back to Canada. Corealis CEO David Leroux-Petersen said the company was pleased to support the clinical manufacture of ALA-002 and its development for potential conditions such as post-traumatic stress disorder (PTSD).
PharmAla said the completion of a GMP drug product formulation is a necessary step toward clinical research, both internally and through partners. The company also said interest in ALA-002 had increased since it signed a US out-licensing agreement earlier in 2026.
