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HSTO - Histogen Inc News Story

$0.793 -0.0  -2.1%

Last Trade - 24/09/21

Sector
Healthcare
Size
Micro Cap
Market Cap £24.2m
Enterprise Value £6.56m
Revenue £1.03m
Position in Universe 6262nd / 7172

Histogen and Amerimmune Announce Positive Top-Line Study Results from its Phase 1 Study of Emricasan in Mild Symptomatic COVID-19 Patients

Tue 22nd June, 2021 1:00pm
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Emricasan Found to be Safe and Well Tolerated with No Serious Adverse Events

Patients Completing Treatment with Emricasan had a Complete Resolution of the
Symptoms Most Commonly Associated in Mild COVID-19 At Day 7 Continuing to Day
45

SAN DIEGO, June 22, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), and
its partner Amerimmune LLC, today announced top line results from its Phase 1
study of emricasan in mild symptomatic COVID-19 patients to assess safety,
tolerability, and preliminary efficacy. The study demonstrated that emricasan
was 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 cough,
headache and fatigue at day 7 and continued through day 45. Patients in the
placebo arm who completed the study did not experience COVID-19 symptom
resolution at any time point out to day 45.

In addition, a number of very important observations were made related to
clinical outcomes, laboratory findings and drug target related biomarkers.
These improvements were seen in all subjects in the active drug group that
showed decreases in caspase biomarkers, whereas patients in placebo group
continued to have COVID-19 related symptoms and laboratory findings.

“The data from the Phase 1 study of emricasan administered in the outpatient
setting underscores its safety and potential clinical benefit in the treatment
of mild symptomatic patients,” said Raavi Gupta, M.D. Associate Professor
and the Principal Investigator at SUNY Downstate Health Sciences University.

“The study data not only showed complete and early resolution of COVID-19
related symptoms in the emricasan group compared to the placebo group, which
continued to have symptoms, but also provided substantial insight into disease
mechanism, which will be critical in developing therapeutic options for
COVID-19. We are excited to work with Histogen to bring Amerimmune’s
expertise to the emricasan development program as a demonstration of how
physician-owned diagnostic laboratories can be the genesis of breakthroughs in
medicine and participate fully in the advancement of novel therapies,” said
Dr. Oral Alpan, M.D. Chief Executive Officer of Amerimmune LLC.

“These positive results further reinforce the extensive clinical safety
database of emricasan and strongly suggest that emricasan can potentially be
developed as a therapeutic treatment for mild to moderate COVID-19, as well as
other viral inflammatory diseases,” said Richard W. Pascoe, Histogen’s
President and Chief Executive Officer. “We look forward to working with our
colleagues at Amerimmune as we chart a strategic course for emricasan and its
clinical development options and partnering opportunities.”

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 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, and dermal rejuvenation. 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; 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; 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; the potential that earlier clinical trials
and studies of Histogen’s product candidates may not be predictive of future
results, such as the data results from the emricasan Phase 1 study; risks
related to business interruptions, including the outbreak of COVID-19
coronavirus, which could seriously harm our 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 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.

CONTACT: 
Susan A. Knudson
Executive Vice President & CFO 
Histogen Inc. 
ir@histogen.com

 

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