Clarus Therapeutics Announces Notice of Allowance for Patent Claims Covering CLAR-121 (Testosterone + Anastrozole) for Treatment of Androgen-Mediated Autoimmune Inflammatory Mastitis
10 Mayo 2022 - 8:05AM
Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a
pharmaceutical company dedicated to providing solutions to unmet
medical needs by advancing androgen and metabolic therapies for men
and women, today announced that it has received a notice of
allowance from the United States Patent and Trademark Office
(USPTO) for claims that cover certain methods for the treatment of
autoimmune inflammatory mastitis that can be achieved by its
product candidate, CLAR-121, a proprietary combination of
testosterone (T) and anastrozole delivered by a subcutaneous
implant.
Patent application No. 17/437,525 is entitled “Pharmaceutical
Formulations and Systems for Delivery of an Androgenic Agent and an
Aromatase Inhibitor with Sustained Multi-Phasic Release Profiles
and Methods of Use.” The U.S. patent scheduled to issue from this
application will expire in June 2040.
“We are thrilled to further establish intellectual property
protection for our pipeline,” said Dr. Robert Dudley, President and
Chief Executive Officer of Clarus. “We believe this notice of
allowance validates the innovation behind CLAR-121 and supports
this novel approach for treating androgen-mediated inflammatory
breast diseases. Our initial focus for CLAR-121 will be for the
treatment of PDM, a painful condition of inflamed breast tissue
that predominantly affects women and for which there is currently
no available drug interventions. We are currently seeking Orphan
Drug Designation from the FDA for CLAR-121 for the treatment of PDM
in the second quarter of 2022 and anticipate initiating a Phase 2
clinical trial in the second half of 2022.”
About CLAR-121 (Testosterone + Anastrozole) for
Inflammatory Periductal Mastitis (PDM)CLAR-121 is a
proprietary combination of T (natural ligand for the androgen
receptor (AR)) and anastrozole (an aromatase inhibitor that blocks
T conversion to estradiol) delivered by a subcutaneous implant for
the treatment of AR-mediated inflammatory breast disease
that predominantly affects women. Clarus acquired development and
commercialization rights from Australia-based HavaH Therapeutics in
May 2021. Clarus initially plans to target inflammatory PDM, also
known as Zuska’s Disease. PDM is a painful, often debilitating
inflammation of breast tissue that affects approximately 150,000
women in the United States each year. There is no known effective
drug treatment for PDM, and often the only medical intervention is
disfiguring surgery. Clarus currently is seeking Orphan Drug
Designation from the FDA for CLAR-121 for the treatment of PDM in
the second quarter of 2022. Clarus also plans to initiate a Phase 2
clinical trial for CLAR-121 for the treatment of PDM in the second
half of 2022, subject to the availability of funding.
About Clarus Therapeutics Holdings, Inc.Clarus
Therapeutics Holdings, Inc. is a pharmaceutical company with
expertise in developing androgen and metabolic therapies for men
and women – including potential therapies for orphan indications.
Clarus’ first commercial product is JATENZO® (testosterone
undecanoate). For more information,
visit www.clarustherapeutics.com and www.jatenzo.com.
Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus
Therapeutics).
Clarus Forward-Looking StatementsCertain
statements in this press release constitute “forward-looking
statements” for purposes of the federal securities laws. The words
“anticipate,” “believe,” “contemplate,” “continue,” “could,”
“estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “potential,” “predict,” “project,” “should,” “will,”
“would” and similar expressions may identify forward-looking
statements, but the absence of these words does not mean that a
statement is not forward-looking. Clarus’ forward-looking
statements in this press release include, but are not limited to,
statements regarding the issuance and timing of expiration of a new
patent covering CLAR-121, seeking orphan drug status for CLAR-121,
and initiation of a Phase 2 clinical trial for CLAR-121 for the
treatment of PDM. These forward-looking statements are based on
current expectations and beliefs concerning future developments and
their potential effects. There can be no assurance that future
developments affecting us will be those that Clarus has
anticipated. These forward-looking statements involve a number of
risks, uncertainties (some of which are beyond Clarus’ control) or
other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risks associated with pharmaceutical
development, risks associated with Clarus’ financial position, and
those factors described under the heading “Risk Factors” in Clarus’
annual report on 10-K for the year ended December 31, 2021 filed
with the Securities and Exchange Commission (the SEC) on
March 31, 2022, and those that are included in any of Clarus’
future filings with the SEC. Should one or more of these risks or
uncertainties materialize, or should any of Clarus’ assumptions
prove incorrect, actual results may vary in material respects from
those projected in these forward-looking statements. Some of these
risks and uncertainties may in the future be amplified by the
ongoing COVID-19 pandemic and there may be additional risks that
Clarus considers immaterial, or which are unknown. It is not
possible to predict or identify all such risks. Clarus’
forward-looking statements only speak as of the date they are made,
and Clarus does not undertake any obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities laws.
JATENZO® is a registered trademark of Clarus Therapeutics
Holdings, Inc.
Clarus Contact:Kara StancellVice President,
Investor Relations & Corporate
Communicationskstancell@clarustherapeutics.com(847) 562-4300 x
206
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