During the meeting, Elicera presented its proposed trial design and received supportive and constructive regulatory guidance from the MPA regarding the clinical protocol, dose-escalation strategy, and product manufacturing specifications. The agency confirmed that the submitted preclinical data package is considered sufficient to support the initiation of clinical development.

“We are very pleased with the constructive and valuable feedback from the MPA,” said Jamal El-Mosleh, CEO of Elicera Therapeutics. “This guidance gives us a clear framework as we finalize the clinical trial design in parallel with process development and tech transfer of the manufacturing process. It is an important milestone on our path toward starting the first clinical study with ELC-401.”