Omeros terminates development of kidney disease therapy after study failure

[October 17, 2023]  By Sriparna Roy

(Reuters) -Omeros Corp said on Monday it will discontinue development of an experimental therapy to treat a type of kidney disease after a late-stage study failure and allocate its resources to other research studies.

Shares of Omeros fell 58% to hit an all-time low of 92 cents, and could lose more than half or about $80 million in market capitalization if losses hold.

An interim analysis of the study data showed the therapy failed to demonstrate a statistically significant improvement in reducing elevated levels of protein in patients' urine, a symptom called proteinuria, compared to placebo.

The company was studying the therapy, narsoplimab, to treat immunoglobulin A nephropathy (IgAN) or Berger's disease, in which germ-fighting proteins build up in the kidneys, damaging tissues and resulting in blood and protein leaking into urine.

Proteinuria reduction in the placebo group was substantially greater than that reported in other studies for IgAN, the company said.

Omeros said it will investigate the unexpected placebo reaction, which was not immediately obvious from the interim data.

"We are left at this point scratching our heads", said CEO Gregory Demopulos on a call with analysts.

Based on the results of the narsoplimab trial, Omeros said it will not submit a marketing application to the U.S. health regulator seeking approval for the therapy.

The decision will help Omeros reduce its cash burn, the drug developer said without disclosing details.

Omeros had reported cash and equivalents of $341.3 million at the end of the second quarter.

The company plans to use the funds earmarked for the commercialization of the therapy in IgAN, for other programs, including ongoing and planned studies for its experimental blood disease therapy, OMS906.

Other studies testing nasoplimab as a treatment for COVID-19 and thrombotic microangiopathy, a complication in patients undergoing bone marrow transplant, will not be impacted, Omeros said.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)

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