PaxMedica completes Type-B meeting with FDA for PAX-101 trial data

PaxMedica announced the completion of a type-B meeting with the FDA. During the live meeting, the company discussed the positive results of the recent data from its PAX-HAT-301 study of suramin in Stage One Human African Sleeping Sickness caused by Trypanosoma brucei rhodesiense, a rare and fatal parasitic disease if left untreated. PaxMedica has received constructive feedback which will aid in the completion of the remaining work necessary to file a New Drug Application expected in the second half of 2024. Most of the work to achieve this important milestone will focus on completing the production of commercial lots of PAX-101 under CMC regulatory guidelines, underway now and scheduled to conclude in the first half of 2024.