The Bell2Bell (B2B) Podcast

In this engaging episode, David Hough shared key updates following PaxMedica's recent meeting with the FDA, highlighting pivotal achievements such as:

• FDA discussion of PaxMedica's data from the PAX-HAT 301 Study and comprehensive nonclinical programs.
• PAX-HAT-301 study confirmed as positive evidence for African Sleeping Sickness treatment, expected to result in substantial time and resource savings for PaxMedica.
• FDA acknowledgment of PaxMedica's comprehensive nonclinical program, including safety pharmacology, ADME, and toxicology studies.
• Waivers granted for the thorough QT/QTc studies, affirming data relevance to the patient population.
• 2024 NDA submission anticipation underscores PaxMedica's commitment to neglected tropical disease treatments.