FDA Grants QIDP to Sulopenem for 4 New Indications

The US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to the oral and intravenous (IV) formulations of sulopenem for 4 new indications, Iterum Therapeutics announced today. The new indications include community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease.

Sulopenem, which is a novel penem anti-infective compound, has demonstrated potent in vitro activity against gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.

In 2017, the FDA granted oral and IV sulopenem QIDP designations for the treatment of uncomplicated urinary tract infection (uUTI), complicated urinary tract infection (cUTI), and complicated intra-abdominal infection (cIAI). Three phase 3 trials are underway in the treatment of in uUTI, cUTI, and cIAI, and top-line data are expected in the second half of 2019.

The FDA has also issued Fast Track designation status for all 7 indications in both the oral and intravenous formulations of sulopenem.

“These additional FDA designations further validate the clinical potential of sulopenem and provide significant additional support for its development. Sulopenem has demonstrated potent in vitro activity against several antibiotic-resistant pathogens for which new treatments are urgently needed,” Michael Dunne, MD, chief scientific officer of Iterum Therapeutics, said in a press release.

QIDP status is designated for products that are being developed to treat serious or life-threatening infections, most importantly those caused by bacteria and fungi that are resistant to treatment.

The QIDP designation will make sulopenem eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now (GAIN) Act. If approved by the FDA, sulopenem would be eligible for an additional 5-year extension of Hatch-Waxman exclusivity.

The Fast-Track status will provide an opportunity for Iterum to engage in more frequent meetings with the FDA, and facilitate written communication about clinical trials, eligibility for Accelerated Approval and Priority Review, and the potential for a Rolling Review.

“If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the effective treatment of resistant pathogens in the community, make possible the avoidance of hospitalization, and facilitate early hospital discharge by providing continuity-of-care step-down therapy,” the company said in the statement.