Histogen Announces Exclusive Intellectual Property License Agreement with Johns Hopkins University
April 03 2023 - 4:05PM
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 that the company has signed an exclusive license
agreement with Johns Hopkins University. The intellectual property
associated with this license covers the use of emricasan for the
treatment of disease in humans resulting from viral or bacterial
infections (including, but not limited to, MRSA, VRSA, and
SARS-CoV-2). The license agreement with Johns Hopkins is an
instrumental addition to Histogen’s intellectual property
portfolio. Rights to these patent applications, together with
recently issued internal patents, are expected to provide freedom
to operate and exclusivity worldwide to the Histogen’s entire
caspase inhibitor portfolio.
“We believe that emricasan has the potential to
treat infections in a different way; by protecting the competence
of the human body’s immune system thereby restoring the body’s
natural process to combat invading organisms,” stated Steven J.
Mento, President and CEO of Histogen. “The World Health
Organization (WHO) names antibiotic resistance as one of the
biggest threats facing humanity. By focusing on optimizing the
immune response, we believe that we have an opportunity to provide
emricasan as a viable treatment option for physicians without the
risk of generating antibiotic resistance. 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 COVD-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 clean carcinogenicity testing. The drug
candidate 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 with
dosing for up to two years, including a Phase 1 study in mild
symptomatic COVID-19 patients to assess safety, tolerability, and
preliminary efficacy. Patients who completed treatment with
emricasan had a complete resolution of the symptoms most commonly
associated with 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 showed either delay or no symptom
resolution for the duration of the study. Additionally, in the
fourth quarter of 2022, we completed our pre-clinical evaluation of
emricasan for the potential treatment of ABSSSI, including those
related to MRSA, and anticipate initiating clinical development
activities for the treatment of ABSSSI in the second half of
2023.
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 license
and our expectation that the license will provide freedom to
operate and exclusivity; 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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