GSK Culls Celiac, S. aureus Candidates on FDA Decision Day for CKD Drug

GSK_Don Murray/Getty Images

Courtesy of Don Murray/Getty Images

GSK has dropped both GSK3915393, an investigational celiac disease therapeutic, and GSK3878858, a Staphylococcus aureus vaccine hopeful, from its clinical development roster, the company revealed Wednesday.

These pipeline changes, included in the company’s Q4 and full-year results, come the same day the FDA is expected to render a verdict regarding daprodustat for adult patients with anemia arising from chronic kidney disease (CKD).

GSK gained rights to the celiac disease drug GSK3915393 when it bought San Diego biotech Sitari Pharmaceuticals in September 2019. The drug works by inhibiting the transglutaminase 2 enzyme, which plays a central role in the pathologic response to gluten in celiac disease.

GSK initiated a Phase I trial of GSK3915393 in October 2020.

Meanwhile, GSK3878858 was designed to address the growing antibiotic resistance by targeting five antigens on the bacterium. The candidate was being assessed in a Phase I/II randomized, placebo-controlled, dose-escalation study in adults with recurrent S. aureus skin and soft tissue infections. The trial began in June 2020.

Aside from the discontinued assets, GSK reported strong growth in 2022, raking in more than $36 billion in sales, which represents a 19% growth at actual exchange rates. Much of this growth was driven the company’s specialty medicines, oncology and HIV businesses, sales of which grew by 37%, 23% and 20%, respectively.

To support its future growth, GSK will look to continue the development of 69 vaccines and immune system-based specialty medicines, 18 of which are in Phase III studies or ready for registration. This pipeline includes the company’s RSV vaccine candidate for older adults, which is awaiting regulatory review in the U.S., E.U. and Japan.

GSK Braces for FDA Decision on CKD Drug

As announced in its full-year financial results, GSK is anticipating four approvals in 2023:

  • Respiratory syncytial virus vaccine for older adults. The vaccine hit the primary endpoint in a pivotal trial, showing a 94.1% reduction in severe disease.
  • Jemperli (dostarlimab) in endometrial cancer
  • Momelotinib in myelofibrosis
  • Daprodustat in anemia from CKD

In October 2022, the Agency’s Cardiovascular and Renal Drugs Advisory Committee delivered a mixed vote on daprodustat, but leaned toward approving the drug only in CKD patients with anemia who are on dialysis. In particular, committee members flagged potential safety concerns, which may outweigh the candidate’s benefit in patients not on dialysis. The FDA is not required to follow the vote of the Committee, but it often does.

GSK submitted data from five studies under the Phase III ASCEND program to support daprodustat’s FDA bid. While the candidate met its primary efficacy endpoints in all trials, it also aggravated the risks of heart failure, bleeding gastric erosions, heart attack and stroke in patients who not dependent on dialysis.

BioSpace will update this story accordingly.

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