Moving Beyond Boundaries: Utilization of Longitudinal Exposure–Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm

The trial for TDM-105795 has been completed, and it was in phase 2A. The discussion seeks input on the next phases, 2B or 3, based on safety and efficacy.

The conversation discusses the safety study of PP405, emphasizing that early trials focus on safety rather than efficacy, and that any efficacy data from such a short study should be viewed skeptically. It also highlights that the information released is primarily for securing funding, and that meaningful efficacy results are expected in later phases.

Analyzing data on pyrilutamide, a potential hair loss treatment, as well as the effectiveness of other treatments such as Minoxidil, Finasteride, and RU58841.

The conversation discusses the delay in the PP405 Phase 2 study results, now expected by the end of 2025, and skepticism about research practices. There is also mention of optimism for Amplifica's AMP303 and a topical treatment in early testing.

The FDA will now require only one clinical trial for drug approval, potentially speeding up the release of hair loss treatments like PP405. Pelage is expected to present full results of PP405 Phase 2a trials and move to Phase III in mid-2026.

People are discussing the anticipated release of PP405 phase 2a results, expected by the end of March, with some skepticism about its effectiveness. There is cautious optimism due to past experiences with similar treatments like Breezula, despite concerns about the lack of presentation at the AAD 2026 conference.