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HSTO - Histogen Inc News Story

$0.71 -0.0  -3.0%

Last Trade - 27/10/21

Micro Cap
Market Cap £22.2m
Enterprise Value £4.68m
Revenue £1.02m
Position in Universe 6384th / 7275

Histogen and Amerimmune Announce Additional Findings from its Phase 1 Study of Emricasan in Mild Symptomatic COVID-19 Patients

Mon 16th August, 2021 1:00pm
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Immunological Data Highlights How Caspase Inhibition May Prevent COVID-19
Disease Progression

Emricasan Found to Have Statistically Significant Improvements in Clinically
Relevant Hematological and Immune Markers Which May Lead to Potential Clinical
Benefits in COVID-19 Patients

SAN DIEGO, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO) and
its partner Amerimmune, LLC today announced additional findings from its Phase
1 study of emricasan in mild symptomatic COVID-19 patients to assess safety,
tolerability, and preliminary efficacy. As previously reported, emricasan was
shown to be safe and well tolerated during the 14 days of dosing and at the
day 45 follow up, as compared to placebo, with no reports of serious adverse
events. Patients who completed treatment with emricasan had a complete
resolution of the symptoms most commonly associated in mild COVID-19, such as
a cough, headache, and fatigue at day 7 and continued through day 45. The
p-value was p<0.007. Patients in the placebo arm who completed the study
showed either delay or no symptom resolution for the duration of the study.

Further analysis of the laboratory and exploratory biomarkers from the
patients in this study shed critical insight into potential mechanisms of
COVID-19 and how emricasan blocks this process to prevent disease progression.
First, in the emricasan cohort, there was an increase in certain blood immune
cell numbers, which play an important role in immunity against viruses.
Second, patients that received emricasan showed normalization of several serum
markers related to increased risk for blood clotting that are typically
elevated in individuals with COVID-19. Third, substances that leak from dying
cells in the body decreased and normalized in the emricasan cohort. These
findings correlated with trends toward better immunity to SARS CoV2.
Collectively, this data points to the role of emricasan in mild COVID19 and
cell death as the core problem in COVID-19.

“The study data has provided us with critical information on the mechanism
of COVID-19, which we believe will be critical for the planning of the next
phase of our clinical development program,” said Dr. Oral Alpan, M.D. Chief
Executive Officer of Amerimmune LLC.

“These additional findings further reinforce that emricasan can potentially
be developed as a therapeutic treatment for mild to moderate COVID-19,” said
Richard W. Pascoe, Histogen’s President and Chief Executive Officer. “We,
along with Amerimmune, are currently developing a Phase 2 clinical strategy
for emricasan as a new therapeutic option for the treatment of COVID-19 in
parallel with exploring partnering opportunities for its future development
and commercialization.”

About the Emricasan Phase 1 Study
This double blinded, 1:1 randomized, placebo controlled single site study
enrolled 13 symptomatic mild-COVID-19 patients in an outpatient setting using
emricasan at 25mg BID dosing for 14 days versus placebo with a one-month
safety follow up. The study was designed to assess safety and tolerability and
also include various clinical and laboratory measures and patient reported
outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult
and Adolescent Subjects in Clinical Trials of Drugs and Biological Products
for COVID-19 Prevention or Treatment Assessment tool. A total of 13 patients
were enrolled at a single site in New York City versus the initially targeted
40 patients. The decision to stop enrollment with a lesser number of patients
was based solely upon the overall decline in COVID-19 cases in New York City
and its negative impact on patient recruitment.

About Emricasan
Emricasan is a potential first-in-class, orally active, pan-caspase inhibitor
designed to reduce the activity of enzymes that mediate inflammation and
apoptosis. Histogen acquired certain rights to emricasan and other caspase
inhibitor compounds as a part of its merger with Conatus Pharmaceuticals Inc.
in 2020. Histogen believes that by reducing the activity of these enzymes,
caspase inhibitors have the potential to interrupt the progression of a
variety of diseases.  To date, emricasan has been studied in over 950
patients in 19 completed clinical trials across a broad range of liver
diseases. In NASH cirrhosis patients in multiple clinical Phase II trials
conducted by Conatus, emricasan demonstrated rapid and sustained reductions in
elevated levels of key biomarkers of inflammation and cell death. These and
similar biomarkers are also believed to be mechanistically linked to the
progression and severity of COVID-19.

About the Histogen and Amerimmune Collaboration
Under the terms of the collaboration, Histogen retains ownership and oversight
over the emricasan asset, responsibility for all regulatory filings and
maintaining the existing emricasan patent portfolio. Amerimmune will fund the
emricasan development efforts, maintain its own portfolio of patents for
caspase inhibition and immunotherapy, and, in collaboration with Histogen,
lead the development efforts. Additionally, Amerimmune has an option to
commercialize emricasan under certain conditions for the sole purpose of
supporting future third-party partnering transactions. Should any such
partnering transaction emerge, Histogen and Amerimmune will share profits
equally. Histogen and Amerimmune manage the collaboration under a joint
development and partnering committee governance structure.  

About Amerimmune
Amerimmune LLC is a research center and immunology laboratory with a strong
focus on identifying underlying mechanisms of immune disorders. Amerimmune’s
mission is to bring relevant science, data, and diagnostic and therapeutic
solutions to diseases that involve the immune system. Amerimmune LLC is a
spinoff of Amerimmune Diagnostics LLC, which is focused on establishing a
network of physician-owned immunology labs across the United States.
Amerimmune Diagnostics’ clinical approach led to the development of the
innovative therapeutics’ technology upon which Amerimmune was founded. When
the COVID-19 pandemic emerged, Amerimmune brought its expertise to bear
against this devastating disease. Amerimmune is a privately held
development-stage company based in Fairfax, VA. For more information and to
explore partnering opportunities, please visit www.amerimmune.com.

About Histogen
Histogen 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
joint cartilage regeneration, spinal disk repair, tendon, ligament, and other
soft tissue repair. 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 our future operations and our
ability to successfully initiate and complete clinical trials, obtain clinical
trial data and achieve regulatory milestones and related timing, including
those related to the timing of providing clinical development guidance on the
emricasan clinical program for the potential treatment of COVID-19; the
potential that future clinical trials will establish efficacy of our product
candidates, including emricasan; the potential for emricasan to be a
first-in-class product; the nature, strategy and focus of our business; the
sufficiency of our cash resources and ability to achieve value for our
stockholders; the sufficiency of Amerimmune’s cash resources and its ability
to further develop emricasan and achieve value for our stockholders; and the
development and commercial potential and potential benefits of any of our
product candidates, including emricasan. We 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 our current expectations, they are subject
to various risks and uncertainties and actual results, performance or
achievements of ours 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 our
product candidates, including potential delays in the commencement, enrollment
and completion of clinical trials and Amerimmune’s ability to further
develop emricasan for the potential treatment of COVID-19, including the
complexity and length of studies required to commercialize emricasan for
COVID-19 and potential delays in the completion of clinical trials; our
dependence on our collaboration partner, Amerimmune, to carry out the
development of emricasan and the potential for delays in the timing of
regulatory approval; competition in the COVID-19 market and other markets in
which we and our collaboration partner operate; the potential that earlier
clinical trials and studies of our product candidates may not be predictive of
future results, such as the week 14 data results from the emricasan Phase 1
study and these additional findings; risks related to business interruptions,
including the outbreak of COVID-19 coronavirus, which could seriously harm our
financial condition and increase our costs and expenses; and the requirement
for additional capital to continue to advance our product candidates,
including emricasan, 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 our filings with the Securities and
Exchange Commission. Except as otherwise required by law, we disclaim 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.

Susan A. Knudson
Executive Vice President & CFO 
Histogen Inc. 



GlobeNewswire, Inc. 2021
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