Entasis Therapeutics Announces Sulbactam-Durlobactam Expanded Access Program for Patients in the U.S.

WALTHAM, Mass., Jan. 26, 2021 (GLOBE NEWSWIRE) — Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced today the availability of an expanded access program (EAP) for sulbactam-durlobactam or SUL-DUR, an investigational drug, for U.S. patients with Acinetobacter baumannii infections, including carbapenem and multidrug resistant strains.

“The ability to provide access to patients in need is consistent with the Entasis mission,” said David Altarac, M.D., Chief Medical Officer. “We are excited to have in place an EAP for patients who are not eligible to participate in our study and who are suffering from a serious and life-threatening infection caused by drug resistant Acinetobacter.”

In cooperation with the FDA, expanded access, also referred to as compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. In this circumstance, Entasis Therapeutics can provide a requesting physician with pre-approval access to SUL-DUR for the treatment of the physician’s patient if specific conditions are met and there is adequate availability of drug supply.

Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to Expandedaccess@entasistx.com. At this time, the EAP is open to patients only in the U.S.

About SUL-DUR
SUL-DUR is an intravenous, or IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a novel broad-spectrum IV β-lactamase inhibitor, or BLI, that we are developing for the treatment of infections caused by Acinetobacter baumannii, including carbapenem-resistant strains. We initiated ATTACK, our single Phase 3 registration trial in April 2019. ATTACK is a global Phase 3 registration trial that is actively enrolling patients at sites in 17 countries including China.

About Entasis
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including sulbactam-durlobactam (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacteriaceae infections) and ETX0462 (targeting Pseudomonas infections). For more information, visit www.entasistx.com.

Entasis Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected and changes in expected or existing competition, changes in the regulatory environment, failure of Entasis’ collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Many of these factors are beyond Entasis’ control. These and other risks and uncertainties are described more fully in the Entasis’ filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Company Contact Kyle DowEntasis Therapeutics
(781) 810-0114
kyle.dow@entasistx.com

Investor Relations ContactJames SaliernoThe Ruth Group
(646) 536-7035 / (646) 536-7028
jsalierno@theruthgroup.com

Media ContactAnnika ParrishThe Ruth Group
(508) 280-6592
aparrish@theruthgroup.com

Source: Entasis Therapeutics Holdings Inc.

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Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

Entasis Therapeutics Announces Sulbactam-Durlobactam Expanded Access Program for Patients in the U.S.

René Russo, PharmD, BCPS

René Russo, PharmD, BCPS

Roger J. Pomerantz, M.D., F.A.C.P.

Christine Ann Miller

Graham G. Lumsden

Marco Taglietti, M.D.

Ankit Mahadevia

Jeffrey Stein, Ph.D.

Evan Loh, M.D.

Michael Dunne, M.D

Ciara Kennedy, Ph.D.

Ted Schroeder

Kevin Finney

Manos Perros, Ph.D.

David Roblin

Stephen Conafay

Christopher J. Burns, Ph.D.

Michael N. Dudley, Pharm.D.

Ramani Varanasi

Corey Fishman

Felix Faupel

Adrian Nivoliez