A Flexible Fixed-Sequence Testing Method for Hierarchically Ordered Correlated Multiple Endpoints in Clinical Trials

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 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.

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.

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.

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.

Hope Medicine's HMI-115 is expected to be released in 2027, with phase 3 trials currently recruiting. Concerns include the safety of targeting prolactin and the potential cost of the treatment.