By Kamal Choudhury
March 9 (Reuters) – Vertex Pharmaceuticals said on Monday that its experimental drug sharply reduced a key sign of kidney damage in a late‑stage trial, putting the company on track to seek U.S. approval by the end of this month.
Shares of the company were up about 7% in extended trading.
The drug, povetacicept, is being developed to treat patients with IgA nephropathy, a serious autoimmune disease that can lead to kidney failure or death in a large proportion of patients within 20 years of diagnosis, Vertex said.
According to interim data from the trial, povetacicept helped reduce protein in urine, a key sign of kidney damage, by 52% after 36 weeks, compared with a 4.3% decline in patients who received placebo.
The results “firmly place povetacicept as a clear competitor and potential leader in IgAN,” BMO Capital Markets analyst Evan Seigerman said.
The drug also reduced the levels of a harmful antibody by about 79.3% and helped clear blood in the urine for over 85% of patients compared with placebo.
The data shows competitive efficacy to Otsuka’s approved treatment Voyxact and compares favorably to Vera Therapeutics’ experimental drug atacicept, Seigerman said.
Vertex said the drug, given as an injection once every four weeks, was generally safe and well-tolerated.
The interim results cover 199 patients who had completed 36 weeks of treatment.
The full 605‑patient trial will continue for two years and will measure whether the drug slows the long‑term loss of kidney function.
Vertex said it plans to complete its full application to the U.S. Food and Drug Administration by the end of March and is using a priority review voucher to cut the standard review time to six months from 10 months.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed)
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