Histogen Announces Completion of Dosing Milestone in its 1b/2a Trial for Androgenic Alopecia in Men
September 10 2020 - 8:00AM
Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics
company focused on developing potential first-in-class restorative
therapeutics that ignite the body’s natural process to repair and
maintain healthy biological function, today announced completion of
patient dosing for the week 6 treatment timepoint in its Phase
1b/2a clinical trial of HST-001, designed to assess the safety,
tolerability and indicators of efficacy of HST-001 for the
treatment of androgenic alopecia in men.
“We are pleased to have accomplished the second of three
treatment timepoints in our HST-001 trial and we remain on track to
announce top line data results in the fourth quarter of this year,”
said Richard W. Pascoe, Histogen’s President and CEO.
“HST-001, if approved, could be a first-in-class product
given its potential to stimulate new long-lasting hair growth in
contrast to existing therapies that focus on reducing hair
loss.”
About the HST-001 Phase 1a/2b TrialThis
blinded, randomized, placebo controlled, single site study has
enrolled 36 subjects with male pattern hair loss using a 2:1
randomization of 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. At
each treatment timepoint (Weeks 0, 6 and 12), subjects will receive
a total of 20 injections, 10 in the temporal recession region and 5
in each vertex scalp region, the most common areas of hair loss in
men with androgenic alopecia. Primary and secondary endpoints
will be assessed at Week 18. 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 HistogenHistogen Inc. is a clinical-stage
therapeutics company focused on developing potential first-in-class
restorative therapeutics that ignite the body’s natural process to
repair and maintain healthy biological function. Histogen’s
innovative technology platform utilizes cell conditioned media and
extracellular matrix materials produced by hypoxia-induced
multipotent cells. Histogen’s proprietary, reproducible
manufacturing process provides targeted solutions across a broad
range of therapeutic indications including hair growth, dermal
rejuvenation, joint cartilage regeneration and spinal disk repair.
For more information, please visit www.histogen.com. For
more information, please visit www.histogen.com.
Forward-Looking StatementsThis 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, obtain clinical trial data and achieve regulatory
milestones and related timing, including those related to the
reporting of topline data for the ongoing HST-001 Phase 1a/2b
clinical trial for the treatment of androgenic alopecia in men; 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, including HST-001. 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, such as the reporting
of the topline data for the ongoing HST-001 Phase 1a/2b clinical
trial for the treatment of androgenic alopecia in men; 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:
Susan A. KnudsonExecutive Vice President &
CFO Histogen Inc. ir@histogen.com
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