Gepotidacin

GSK recently scored a regulatory success against complicated UTIs when the FDA approved Blujepa.\n GSK’s decision to swoop in and save Spero Therapeutics’ antibiotic three years ago appears to have paid off based on a fresh phase 3 readout.The trial of 1,690 hospitalized patients with complicated urinary tract infections (cUTIs) has been halted early after it looked certain that the candidate, called tebipenem HBr, would hit the study’s primary endpoint of showing its non-inferiority to intravenous treatment with the antibiotic imipenem/cilastatin.Armed with the new phase 3 data, GSK is planning its own push for a potential FDA review this year. If it gets the nod from the regulator, tebipenem HBr would become the first oral carbapenem antibiotic available for U.S. patients with cUTIs, GSK pointed out in a May 28 release.“Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock,” GSK Chief Scientific Officer Tony Wood, Ph.D., said in the release.“Currently, many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections, contributing to over $6 billion per year in U.S. healthcare costs,” Wood added. “These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home.”GSK recently scored a regulatory success against uncomplicated UTIs when the FDA approved its antibiotic Blujepa, also known as gepotidacin, in March. The Big Pharma saw similar promise in tebipenem HBr back in 2022, despite the FDA having at the time recently rejected Spero’s approval application. The biotech used the $66 million upfront payment it received from GSK as part of the licensing deal to fund the phase 3 trial that read out today.“Achieving the primary endpoint in the PIVOT-PO trial marks a significant milestone for tebipenem HBr,” Spero’s CEO Esther Rajavelu said in this morning’s release. “If approved, we believe tebipenem HBr is well-positioned to change the treatment landscape for patients diagnosed with cUTI, including pyelonephritis.”The late-stage win for tebipenem HBr is a welcome boost for Spero, which has spent the past year navigating layoffs and stripping back its pipeline. This included halting work on the oral antibiotic SPR720 after it failed to beat placebo and showed signs of liver toxicity in a phase 2 trial for non-tuberculous mycobacterial pulmonary disease.The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.

Dive Brief: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. Its 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.Dive Insight: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 Blujepa for people with certain uncomplicated urinary tract infections.GSK bought most 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 companys marketing application in January 2022. But then the FDA challenged the companys study analysis and ended up rejecting the medicine in June 2022. Almost all of Speros market value was wiped out.The latest news caused Speros 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. '