Iterum Therapeutics Announces Transition of Michael Dunne, M.D. to Strategic Advisor and Member of the Board of Directors
--Dr. Dunne resigns as Chief Scientific Officer--
-- Steven Aronin, M.D., Senior Vice President and Head of Clinical Development, to lead Development and Regulatory Activities--
DUBLIN, Ireland and CHICAGO, Dec. 23, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that Dr. Michael Dunne has resigned from his role as Chief Scientific Officer of the Company, effective December 21, 2020. Dr. Dunne has agreed to be a strategic advisor to the Company actively working as a consultant throughout the regulatory review and potential approval of the Company’s pending NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen upon terms and conditions to be agreed by the Company and Dr. Dunne. Dr. Dunne has also been elected to the Company’s Board of Directors, effective as of December 22, 2020. The Company’s Senior Vice President and Head of Clinical Development, Dr. Steve Aronin, will lead the Company’s development and regulatory activities following the effective date of Dr. Dunne’s resignation.
“Mike has been instrumental in the development of sulopenem, and we thank him for his many contributions to date. We are excited that he will continue on with the Company as a trusted advisor and
Board member during this important phase of the regulatory review process,” said Corey Fishman, Chief Executive Officer. “We are confident that with Steve’s experience as an infectious disease
physician and his deep understanding of sulopenem’s clinical development program, he will provide exceptional leadership to our regulatory and development functions. As we move closer to an
anticipated FDA decision regarding our pending NDA in the third quarter of 2021, we will continue to transition from a development to a commercial organization.”
In November 2020, the Company submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uUTIs
in patients with a quinolone non-susceptible pathogen.
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.