Histogen Inc. (HSTO) Announces Week 26 HST-001 Study Results for the Treatment of Androgenic Alopecia in Men

February 16, 2021 8:13 AM EST

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Histogen Inc. (NASDAQ: HSTO) today announced week 26 results from its Phase 1b/2a clinical trial of HST-001 in male patients with androgenic alopecia. At the week 26 timepoint, patients treated with HST-001 demonstrated statistically significant change from baseline in total hairs (terminal and vellus) in the target area (TAHC) in the vertex as measured by Canfield’s Hairmetrix macrophotography system. HST-001 was also shown to be safe and well tolerated at week 26 as compared to placebo with no reports of serious adverse events. Similar to the week 18 primary endpoint results we reported in December of 2020, HST-001 did not achieve statistical significance at week 26 when compared to placebo.

"The recently completed study demonstrated that HST-001 was safe, well tolerated, and exhibited signals of efficacy. This data will inform future development, and I look forward to working with Histogen and our other expert advisors as we plan and execute the next study in men with androgenetic alopecia," said Dr. Stacy Smith, M.D., founder of the California Dermatology and Clinical Research Institution and principal investigator for the HST-001 trial.

“We are encouraged that these results demonstrated that patients treated with HST-001 grow both terminal and vellus hairs in men with androgenic alopecia,” said Richard W. Pascoe, Histogen’s President and CEO. “Moreover, 84% of the subjects who received HST-001 responded to treatment over the 26-week period and the study drug was found to be safe and well-tolerated across all subjects. With this data in hand, we have begun planning for a more substantive clinical trial in men with androgenic alopecia with the goal of determining the best clinical pathway for future registration trials. We anticipate the trial will commence in the second half of 2021.”

About the HST-001 Phase 1a/2b StudyThis 2:1 randomized, blinded, placebo controlled, single site study enrolled 36 male patients with androgenic alopecia with mild to moderate hair loss on a Norwood-Hamilton (N-H) Scale (3V, 4, 5), with a total of 30 evaluable patients at week 26. It was designed to assess the safety and tolerability of HST-001, as well as indicators of efficacy at weeks 18 and 26. The primary study endpoint is absolute change from baseline versus week 18 in total hairs (terminal and vellus) in the (TAHC) of the vertex as measured by Canfield’s Hairmetrix macrophotography system. Secondary endpoints include absolute change from baseline in total hairs (terminal and vellus) new terminal and vellus hair count, hair thickness density and percent change from baseline in TAHC, terminal and vellus hair counts in the vertex and right temporal regions at weeks 18 and 26, all as measured by Canfield’s Hairmetrix macrophotography system. At each treatment timepoint (Weeks 0, 6 and 12), patients received a total of 20 injections, 10 in the vertex scalp region and 5 in each temporal region for a total dose of 2mL.

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