PharmAla Biotech Holdings announced the successful completion of Good Manufacturing Practice (GMP) manufacturing of drug substance necessary for the manufacturing of ALA-002. This milestone marks a significant step forward in the program’s development, providing sufficient material to support upcoming clinical activities.

With drug substance manufacturing now complete, the company is prepared to begin GMP manufacturing of the drug product, the formulated finished form that will be used in clinical activities globally. The successful scale-up and execution of the drug substance batch under GMP conditions demonstrate the maturity and reproducibility of the company’s manufacturing process and underscore its readiness to advance ALA-002 toward the clinic.

Farnoud Kazemzadeh, COO, PharmAla Biotech, said, “This GMP manufacturing milestone represents not only an important step in PharmAla’s development, but a key achievement for the development of the second generation of MDMA analogues. PharmAla’s management team has worked hard to ensure that ALA-002’s development will accelerate in the coming months, with manufacturing of the drug substance being the ‘starting gun’.”