Histogen Announces Online Publication in the Journal of Investigative Dermatology
April 20 2023 - 3:15PM
Histogen Inc. (HSTO), a clinical-stage therapeutics
company focused on developing potential first-in-class
clinical and preclinical small molecule pan-caspase and
caspase selective inhibitors that protect the body’s natural
process to restore immune function, today announced the online
publication of an abstract describing a preclinical study showing
that emricasan has therapeutic effect against bacterial skin
infections.
In the study, the role of the irreversible pan-caspase inhibitor
emricasan alone and in combination with a standard-of-care
antibiotic, doxycycline, was examined as potential host-directed
immunotherapy against bacterial infections in vivo. Mice in four
groups; placebo, placebo plus doxycycline, emricasan plus
doxycycline, and emricasan alone were treated orally twice daily
for 7 days after intradermal injection of the established CA-MRSA
strain USA300 LAC:: lux of Staphylococcus aureus in mice. The
results of the study show that: 1) emricasan alone reduced both
lesion size and bacterial burden versus placebo (p<0.0001); 2)
emricasan alone showed efficacy superior to doxycycline alone in
lesion size (p=0.02); and 3) emricasan alone and emricasan plus
doxycycline showed comparable efficacy versus placebo in both
lesion size and bacterial burden (p<0.0001).
“The data from this study collectively support the use of
emricasan as a potential host-directed immunotherapy against MRSA
skin infections,” stated Steven J. Mento, President and CEO of
Histogen. “The fact the emricasan works as good as or better than
an antibiotic alone in this preclinical study points to the
opportunity to provide emricasan as a viable treatment option for
physicians without the risk of generating antibiotic resistance.
Following the notice from the FDA related to our recently filed IND
that the “Study may Proceed,” we look forward to the anticipated
initiation of clinical development activities using emricasan for
the treatment of acute bacterial skin and skin structure infections
(ABSSSI) in the second half of 2023,” concluded Dr. Mento.
As announced previously, emricasan improved symptoms in patients
infected with COVID-19 potentially employing a similar mechanism of
protecting the competence of the immune system. Patients in the
placebo arm who completed the study showed either delay or no
symptom resolution for the duration of the study.
About Emricasan
Emricasan is an orally available pan-caspase inhibitor designed
to reduce the activities of human caspases, which are enzymes
that mediate inflammation and apoptosis. Emricasan has
completed extensive toxicology testing including chronic
toxicology and all required carcinogenicity testing. Emricasan has
previously been shown to be well tolerated in multiple clinical
studies involving approximately 1,000 subjects employing multiple
doses ranging from 1 mg to 500 mg orally and has been dosed
chronically for up to two years in immunosuppressed patients.
Emricasan was tested in a Phase 1 study in mild symptomatic
COVID-19 patients to assess safety, tolerability, and preliminary
efficacy. Five of five patients who completed treatment with
emricasan had a complete resolution of the symptoms most commonly
associated with mild COVID-19 by day seven compared to zero of six
on placebo. Four of five patients on emricasan compared with one of
six patients on placebo were virus negative by day fourteen. The
mean antibody index against COVID was 6.98 in emricasan treated
patients compared to 5.32 in those receiving placebo at the end of
the study on day forty-five.
About Histogen Inc.
Histogen Inc. is a clinical-stage therapeutics company focused
on developing potential first-in-class clinical and preclinical
small molecule pan-caspase and caspase selective inhibitors
that protect the body’s natural process to restore immune
function. Currently, we are developing emricasan for ABSSSI as
well evaluating its use for other infectious diseases. Our pipeline
also includes novel preclinical product candidates including
CTS-2090 and other proprietary caspase inhibitors, which are
selective small molecule inhibitors of caspase-1 designed for the
treatment of certain inflammatory diseases. 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 the potential benefits of the
preclinical study in mice showing that emricasan has therapeutic
effect against bacterial skin infections; the potential benefits of
emricasan, if approved; our future operations and our ability to
successfully initiate, enroll and complete clinical trials, obtain
clinical trial data, and achieve regulatory milestones and related
timing, including those related to the initiation of clinical
trials for 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
Histogen that could differ materially from those described in or
implied by the statements in this press release, including: our
ability to obtain funding for our operations, including funding
necessary to complete further development and any commercialization
of our product candidates; including its ability to carry out the
development of emricasan and the potential for delays in the timing
of regulatory approval and the requirement for additional capital
to continue to advance these product candidates, which may not be
available on favorable terms or at all; our expectations regarding
the operation of our product candidates and related benefits; our
beliefs regarding the success, cost and timing of our product
candidate development and current and future clinical trials and
studies; our beliefs regarding the potential markets for our
product candidates; any impact of the COVID-19 pandemic, or
responses to the pandemic, on our business, clinical trials or
personnel; our beliefs regarding our industry; our ability to
attract and retain key personnel; regulatory developments in the
United States and foreign countries, with respect to our product
candidates; the impact of any litigation proceedings on our
business and market and other conditions. 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, 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, COO & CFO Histogen Inc. ir@histogen.com
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