GSK, Spero stop UTI drug trial after early success

GSK, Spero stop UTI drug trial after early success

• GSK plans to seek approval of a new antibiotic for complicated urinary tract infections after the drug succeeded in a Phase 3 trial.
• An independent monitoring board recommended ending the study early based on the efficacy of the medicine, known as tebipenem HBr, GSK said Wednesday. It’s part of a class of antibiotics known as carbapenems and could be the first oral drug in that group approved to treat complicated urinary tract infections, GSK said.
• The study, dubbed Pivot-PO, compared tebipenem with a common intravenous antibiotic treatment in patients hospitalized with complicated urinary tract infections. Tebipenem met the goal of non-inferiority and showed no new safety concerns beyond what had been seen in previous research, GSK said. The most common side effects were diarrhea and headaches.

• With the success of the study, GSK is now hoping to offer doctors yet another new weapon to fight the surge in antimicrobial resistance. In March, the British drugmaker won Food and Drug Administration approval for a new kind of oral antibiotic now sold as Blujepafor people with certain uncomplicated urinary tract infections.
• GSK boughtmost of the rights to tebipenem in 2022 from Spero Therapeutics, as the Massachusetts biotech was reeling from an FDA rejection of the medicine. At the time, GSK made an investment in Spero and paid the company $66 million upfront. The agreement included the possibility of royalties for Spero plus as much as $525 million in payments for reaching certain regulatory and sales milestones.
• Spero long thought it had a winning antibiotic on its hands to help treat drug-resistant bacterial infections. A Phase 3 trial in 2020 looked successful and the FDA accepted the company’s marketing application in January 2022. But then the FDA challengedthe company’s study analysis and ended up rejecting the medicine in June 2022. Almost all of Spero’s market value was wiped out.
• The latest news caused Spero’s stock price to more than triple, climbing to about $2.15 early Wednesday. The shares, which traded around $22 in December 2020, closed at 68 cents apiece on Tuesday.
• GSK said it plans to submit its application to the FDA in the second half of this year. Researchers also intend to share full results from the Pivot-PO study at an upcoming medical meeting and in a peer-reviewed medical journal, GSK said.