Histogen Announces First Patient Dosed in Phase 1b/2a Trial of HST 001 for Androgenic Alopecia

SAN DIEGO, June 01, 2020 (GLOBE NEWSWIRE) — Histogen Inc. (NASDAQ: HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the enrollment of the first patient in its Phase 1b/2a clinical trial of HST 001, the Company’s lead therapeutic candidate for the treatment of androgenic alopecia in men.
This blinded, randomized, placebo controlled, single site study will enroll 36 subjects with male pattern hair loss using a 2:1 randomization HST 001 to placebo. It is designed to assess the safety and tolerability of HST 001, as well as indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography.“The initiation of this clinical trial is a critical milestone for Histogen following the completion of our merger and listing on the Nasdaq Capital Market last week,” said Richard Pascoe, Chief Executive Officer of Histogen. “HST 001 is a potentially transformative approach to treating androgenic alopecia given that existing therapies focus on reducing hair loss, while HST 001 has the potential to stimulate new long-lasting hair growth.”Building on prior clinical experience with HST 001, the Phase 1b/2a study will be the first company-sponsored trial to include a third dosing timepoint, with dosing taking place at week 0, week 6 and week 12. At each treatment timepoint, subjects will receive 20 injections focused on temporal recession and vertex scalp areas, the most common regions of hair loss in men with androgenic alopecia. Top-line data is anticipated to be available in the fourth quarter of 2020.About HST 001
HST 001, or Hair Stimulating Complex (HSC), is intended to be a physician-administered therapeutic for hair loss. HSC is anticipated to be a relatively safe, minimally invasive treatment that promotes new hair growth where existing treatments only reduce hair loss. HSC is manufactured to enrich for growth factors including KGF, VEGF, and follistatin, which are involved in signaling stem cells in the body and have been shown to be important in hair formation and the stimulation of resting hair follicles.About Histogen
Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, please visit www.histogen.com.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen’s future operations and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones and related timing; the nature, strategy and focus of Histogen’s business; and the development and commercial potential and potential benefits of any of Histogen’s product candidates. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen’s product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen’s financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen’s filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.CONTACT: Eileen Brandt
Histogen Inc.
(858) 526-3106
ebrandt@histogen.com