Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote.
It has been a bumpy rollercoaster ride for many biopharma companies throughout the pandemic, but overall, the 17 firms that make up BioWorld’s Infectious Disease Index are coming out ahead this year with stocks up by 44.8%.
While biopharmaceutical research is currently concentrating on the threat posed by the COVID-19 pandemic, the disease has provided a sharp reminder that our focus should not be lost on infectious diseases as a whole, along with the growing global problem of antibiotic resistance (AMR), which has the potential to dwarf COVID-19 in terms of deaths and economic costs, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Two phase III stumbles of Iterum Therapeutics plc’s sulopenem have cast the company’s future in doubt. The latest problem is the failure of the penem anti-infective compound, with oral and I.V. formulations, failing to achieve statistical noninferiority relative to ertapenem in treating complicated urinary tract infection (cUTI).
The public attention that COVID-19 has received has spilled over to antibiotics companies, and the BioWorld Infectious Diseases index has grown 14% in value since the beginning of the year.
Iterum Therapeutics plc found a lifeline in the securities purchase agreement it made with an investors group for a $51.9 million private placement. The company plans to use that money to develop sulopenem, a penem anti-infective compound with oral and I.V. formulations.
The warning bells about the global threat of the rise of antimicrobial-resistant (AMR) infections and dearth of new antibiotics seem to have been ringing for several years now. However, the prospects of companies developing new antibiotics, buoyed by regulatory incentives and grant funding, should on the face of it be an attractive proposition for investors.
Shares of Iterum Therapeutics plc (NASDAQ:ITRM) slid 36%, or $1.73, to close at $3.12 after the Dublin-based firm disclosed the much-anticipated but less-than-stellar results from the phase III trial called Sulopenem for Resistant Enterobacteriaceae, or SURE 3, testing oral and I.V. versions of the drug in complicated intra-abdominal infections (cIAI).