Spero Therapeutics announced that the FDA has accepted an investigational new drug application for SPR994, an oral carbapenem antibiotic, for the treatment of complicated UTIs.
The acceptance allows Spero to begin enrolling participants from the United States in a planned global, phase 3 clinical trial comparing SPR994 with IV ertapenem, the company said.
SPR994 is a novel investigational formulation of tebipenem, which is marketed in Japan as Orapenem (Meiji Seika Pharma). Spero licensed SPR994 from Meiji in 2017. It is designed to be the first oral carbapenem antibiotic for use in adults, Spero said.
“With the FDA’s acceptance of our [investigational new drug] application for SPR994, we are excited to continue our phase 3 initiation efforts, including opening clinical trial sites for enrollment in the U.S.," Spero CEO Ankit Mahadevia, MD, said in a news release.
"We look forward to enrolling patients in our single pivotal phase 3 clinical trial with the hope, following approval, of providing patients with the option for an oral carbapenem to address the serious unmet need of multidrug-resistant infections.”
Spero Therapeutics announces FDA acceptance of IND application for SPR994. 2019. Available at: https://investors.sperotherapeutics.com/news-releases/news-release-details/spero-therapeutics-announces-fda-acceptance-ind-application. Accessed February 5, 2019.