PharmAla Biotech has retained Clerkenwell Health, a UK-based Contract Research Organization, to assist PharmAla in regulatory proceedings with both the FDA and the UK Medicines and Health Regulatory Authority (MHRA). PharmAla intends to bring ALA-002, its leading Novel Chemical Entity (NCE), to both jurisdictions. ALA-002 was designed to provide the same efficacy as MDMA, has an improved safety profile, including Cardio- and Neuro-tox, and fewer adverse events.
"PharmAla have a unique and exciting strategy, which could present real improvements to clinical development and application of empathogens" said Dr Henry Fisher, Co-founder and Chief Scientific Officer at Clerkenwell Health. "Engaging with both the MHRA and the FDA on their behalf is also an important milestone for us as we widen our clinical research footprint."
Clerkenwell will provide regulatory support for ALA-002 in both the UK and USA. The agreement also countenances the potential to drive more molecules through the pharmaceutical regulatory approvals pathway. PharmAla continues to develop additional molecules, including its ABA series of non-controlled MDMA analogues, and further NCEs still under development.
"Clerkenwell represents an excellent partner to push forward our regulatory efforts," said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. "They have brought not only excellent experience with regulatory affairs in two different key jurisdictions, but also represent the capability to execute clinical research at their UK facility. We're incredibly pleased to have them as partners."
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