Express | US$75 million in late-stage clinical therapy, GSK expands antibiotic pipeline

▎WuXi AppTec Content Team Editor

Recently, GSK and Spero Therapeutics jointly announced that GSK will receive an exclusive license to Spero’s late-stage antibiotic drug tebipenem HBr. The exclusive license will allow GSK to commercialize tebipenem HBr in all territories except Japan and certain other Asian countries.

Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s late-stage beta-lactam carbapenem oral antibiotic. The antibiotic has been used in Japan since 2009 under the trade name Orapenem to treat pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important subclass of antibiotics that have been observed to be safe and effective in the treatment of resistant Gram-negative bacterial infections.

Tebipenem HBr is being developed to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis (AP), caused by certain bacteria. If approved, tebipenem HBr would be the first oral carbapenem to receive marketing approval in the U.S., the press release states. Currently, Tebipenem HBr has received FDA Qualified Infectious Disease Product Designation (QIDP) and Fast Track designation for the treatment of cUTI and AP. Based on feedback from the FDA, Spero will conduct an additional Phase 3 trial in 2023 to support regulatory approval.

Under the license agreement, Spero will be responsible for the execution and cost of the follow-up Phase 3 clinical trial of tebipenem HBr, and GSK will be responsible for the execution and cost of the additional development, including the Phase 3 oversight of tebipenem HBr outside of Japan Filing and commercialization activities. Spero will receive an upfront payment of $66 million from GSK and the remaining potential payments will be based on milestones. In addition, GSK purchased $9 million of Spero common stock and became a Spero shareholder.

Image credit: 123RF

GSK’s Chief Commercial Officer, Mr. Luke Miels, said: “Currently, there is still a huge unmet need for novel oral antibiotics as an alternative to intravenous administration in the hospital for the treatment of drug-resistant complex urinary tract infections. demand. Tebipenem HBr complements GSK’s infectious disease strategy and aligns with our commitment to finding value-enhancing opportunities to build a strong late-stage portfolio. The potential FDA approval path for Tebipenem HBr is well established, which will enable complex urology Infected patients greatly benefit.”

Spero’s Chief Executive Officer Dr. Ankit Mahadevia said: “Spero’s agreement with GSK is a critical step towards fully realizing the value that tebipenem HBr may provide to physicians, payers and patients. We Excited to partner with GSK to develop tebipenem HBr for patients with cUTI. Upon regulatory approval, tebipenem HBr will serve as the first oral therapy for cUTI, providing patients with an alternative to in-hospital intravenous therapy. Tebipenem HBr has the potential to serve as a home Oral option and may yield significant benefits by reducing hospital resource utilization.”

WuXi AppTec provides integrated, end-to-end new drug R&D and production services for the global biopharmaceutical industry, covering chemical drug R&D and production, biological research, preclinical testing and clinical trials R&D, cell and gene therapy R&D, testing and production. If you have relevant business needs, please click the picture below to fill in the specific information.