Discussion of 'A Hybrid Phase I-II/III Clinical Trial Design Allowing Dose Re-Optimization in Phase III' by Andrew G. Chapple and Peter F. Thall

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.

PP405's phase 2a trial results were presented, focusing on safety and pharmacokinetics, with a future meeting planned to share the full dataset. The trial includes a randomized controlled portion and an open-label extension, with no indication of phase 2B completion.

PP405 trials have completed phase 2a, showing promising results with a 31% stat for hair density increase, and are moving directly to phase 3. Detailed results will be presented at a medical conference in 2026.

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 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.

People are discussing their reactions if PP405 fails in phase 3 trials, with some expressing skepticism and others holding onto hope for future treatments like GT20029 and Breezula. Many mention continuing with existing treatments like minoxidil and finasteride, while others express disappointment and consider alternative solutions.