Clarus Therapeutics Announces Notice of Allowance for Patent Claims Covering CLAR-121 (Testosterone + Anastrozole) for Treatment of Androgen-Mediated Autoimmune Inflammatory Mastitis

May 10, 2022

Initial focus for CLAR-121 is the treatment of periductal mastitis (PDM) in women

Clarus is seeking Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in the second quarter of 2022

Initiation of Phase 2 clinical trial for CLAR-121 for the treatment of PDM anticipated in the second half of 2022

NORTHBROOK, Ill., May 10, 2022 (GLOBE NEWSWIRE) -- 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 Statements
Certain 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 Stancell
Vice President, Investor Relations & Corporate Communications
kstancell@clarustherapeutics.com
(847) 562-4300 x 206