Antares Pharma Initiates Phase I Study For ATRS-1902 For Adrenal Crisis Rescue

Rhea-AI Summary

Antares Pharma has begun a Phase 1 study for ATRS-1902, focusing on adrenal crisis rescue treatment using a new auto-injector platform. This innovative platform delivers a liquid stable formulation of hydrocortisone, eliminating the need for reconstitution. The study seeks to establish the safety, tolerability, and pharmacokinetics of ATRS-1902, comparing it with Solu-Cortef. Results are expected in 1Q 2022, and the company aims to submit a 505(b)(2) NDA to the FDA if results are favorable.

Positive

• Initiation of Phase 1 study for ATRS-1902, indicating progress in clinical development.
• Introduction of a novel auto-injector platform expected to simplify administration for patients in adrenal crisis.

Negative

• Success of the Phase 1 study and future regulatory approval remain uncertain.
• Dependence on favorable outcomes for potential FDA submission could pose risks.

Pharmacokinetic data results expected in 1Q 2022

EWING, N.J., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that it has initiated a Phase 1 study for ATRS-1902 for adrenal crisis rescue. The development program supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone.

“We are pleased to be able to dose the first subjects for this study with a liquid stable dosage that eliminates the need for reconstitution. The opportunity to provide an essential treatment that can be easily administered for a potentially life-threatening situation remains a core focus of our research and development efforts. We remain committed to progressing our internal clinical programs to help expand our commercial portfolio,” commented Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma.

Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, “The initiation of this study demonstrates our ongoing commitment to helping underserved patients in the area of rescue therapies. Our development team created a new device platform specific to the needs of patients experiencing adrenal crisis. As a leader in rescue pen technology, we hope to be able to provide a simple injection for patients in crisis versus the multiple step process required for the current standard of care. If successful in this Phase 1 study, we expect to then conduct a bioequivalence study and second human factor study that will form the basis of a 505(b)(2) NDA filing with the FDA.”

The Phase I study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a liquid stable formulation of hydrocortisone. The study is a cross-over design to establish the PK profile of ATRS-1902 (100 mg) compared to Solu-Cortef^® (100 mg), the reference-listed drug, in 32 healthy adults.

About Antares Pharma

Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED^® (testosterone enanthate) injection, OTREXUP^® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA^® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the timing and results of the clinical development program for ATRS-1902 adrenal crisis rescue auto-injector including the timing and results of the Phase 1 study and future regulatory approval; the Company’s ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED^® and future revenue from the same; market acceptance of Teva’s generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP^®; successful commercialization of NOCDURNA^® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals’ Makena^® subcutaneous auto injector following the FDA letter seeking withdrawal, the outcome of the FDA hearing and whether Makena^® will be successful and future prescriptions, market acceptance and revenue from the same; Teva’s ability to successfully commercialize VIBEX^® Sumatriptan Injection USP and the amount of revenue from the same; Teva’s ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same;, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same; FDA approval of Teva’s ANDAs for both generic Forteo^® and Byetta^® and future revenue from the same; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development including the Company’s urology assets in development as well as Pfizer’s undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to repay the debt obligation to Hercules Capital; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

Contact:
Tram Bui
Vice President, Corporate Communications and Investor Relations
609-359-3016
tbui@antarespharma.com

FAQ

What is ATRS-1902 and its purpose?

ATRS-1902 is an injectable treatment under development by Antares Pharma for adrenal crisis rescue, using a novel auto-injector platform.

When are the results for the ATRS-1902 study expected?

The pharmacokinetic data results for the ATRS-1902 study are anticipated in 1Q 2022.

What company initiated the Phase 1 study for ATRS-1902?

Antares Pharma is the company that initiated the Phase 1 study for ATRS-1902.

What does the Phase 1 study for ATRS-1902 aim to evaluate?

The study aims to evaluate the safety, tolerability, and pharmacokinetics of ATRS-1902 compared to Solu-Cortef.

What could be the next steps after the Phase 1 study of ATRS-1902?

If successful, Antares Pharma plans to conduct a bioequivalence study and a human factor study, leading to a potential 505(b)(2) NDA filing with the FDA.