Histogen Announces Preliminary Week 18 HST-001 Study Results for the Treatment of Androgenic Alopecia in Men

HST-001 Demonstrated Separation from Placebo at Week 18 Primary Efficacy Endpoint Assessment

HST-001 Found to be Safe and Well Tolerated with No Serious Adverse Events

Week 26 Final Study Results for HST-001 Expected in Early First Quarter of 2021

SAN DIEGO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), today announced preliminary week 18 results from its Phase 1b/2a clinical trial of HST-001 in male patients with androgenic alopecia. At the week 18 primary efficacy endpoint, patients treated with HST-001 demonstrated separation from placebo patients for absolute 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 18 as compared to placebo with no reports of serious adverse events.

“While HST-001 did not achieve statistical significance at the week 18 primary endpoint assessment, we are encouraged that these results demonstrated separation from placebo and that patients treated with HST-001 grew new hairs in the vertex region of the scalp while placebo patients lost hairs in the same region during the 18 week evaluation period,” said Richard W. Pascoe, Histogen’s President and CEO. “We look forward to completing the study and reporting the final results from the week 26 assessments, along with our plans for further clinical development of HST-001, in early first quarter of 2021.”

About the HST-001 Phase 1a/2b Trial
This 2:1 randomized, blinded, placebo controlled, single site study has enrolled 36 male patients with androgenic alopecia with mild to moderate hair loss on a Norwood-Hamilton (N-H) Scale (3V, 4, 5). It is 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 as well as percent change from baseline in TAHC and 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. Final study results post week 26 assessments are expected in early first quarter of 2021.