In a significant development for individuals suffering from androgenetic alopecia, Hope Medicine has officially kicked off the HMI-115 phase II trials. HMI-115 is an antibody aimed at combatting this common form of hair loss. This milestone marks a crucial step forward in Hope Medicine’s ongoing quest to find an effective treatment for this condition.
FROM PHASE I TO THE AUSTRALIAN TRIAL
Nearly two years ago, Hope Medicine received approval to embark on a phase II clinical trial from the U.S. Food and Drug Administration (FDA). This sparked excitement and hope within the field of hair loss research. Subsequently, the company opted to initiate a phase 1 trial for HMI-115 in Australia, involving both male and female participants. During this phase I trial, speculations and rumors circulated on various online forums, hinting at positive efficacy results for HMI-115. Today, we are delighted to announce the launch of the phase II trial for HMI-115. It should be noted that this stage is not being conducted within the United States.
PHASE II STUDY PARAMETERS
A recent listing on the Clinical Trials website has provided valuable insights into the specifics of the phase II study for HMI-115:
- Participant Profile: The trial will enlist the participation of 180 male subjects.
- Treatment Duration: All participants will undergo a 24-week (6-month) treatment period.
- Commencement Date: The phase II trial commenced in September 2023 and is scheduled to conclude by December 2024.
- Study Design: It is designed as a randomized, multicenter, double-blind, and placebo-controlled study.
- Primary Outcome: The primary outcome measure will focus on the mean change in target area hair count (TAHC) of non-vellus (terminal) hairs from baseline.
- Eligibility Criteria: Individuals with Norwood scales 3 vertex, 4, and 5 are eligible to participate.
- Treatment Cohorts: The trial will consist of four cohorts, comprising a placebo group and three groups receiving HMI-115 injections at varying intervals: 120mg once every four weeks, 240mg once every four weeks, or 240mg once every two weeks.
THE FUTURE FOR HMI-115
While the initiation of a phase II trial for HMI-115 brings renewed hope for individuals seeking effective hair growth treatments, questions linger regarding Hope Medicine’s approach to addressing female pattern hair loss. The phase I trial included female participants, and depending on the outcomes, the company may consider launching a dedicated phase 2 trial tailored to female pattern hair loss in pursuit of FDA approval. As of now, Hope Medicine’s plans regarding a phase 2 trial in the United States remain shrouded in uncertainty and may follow the completion of the trial in China.
CONCLUSION
The conclusion of this newly launched HMI-115 phase II trial holds the promise of providing official efficacy data for HMI-115. This offers vital insights into its potential as a treatment for androgenetic alopecia. With an estimated completion date in Q3 2024, there is the possibility of data becoming available before the close of 2024. The future appears bright for Hope Medicine, bolstered by their recent announcement of a strategic business development partnership with Chime Biologics, focused on scaling up and manufacturing their monoclonal antibody drug, HMI-115. This collaboration underscores their unwavering commitment to advancing this innovative solution for hair loss.
View the full Hope Medicine announcement here.