Corgentech 4975 trial data shows no significant pain relief in hernia patients

By Elaine Rigoli

Tampa, Fla., March 24 - Corgentech, Inc. said clinical results from a phase 2 trial of 4975, a long-acting, non-opioid drug candidate being developed in multiple mid-stage clinical trials for site-specific, moderate to severe pain, showed no significant pain relief in patients.

While 4975 was well tolerated at all time points during the study, there was no significant difference in pain score in the drug versus control arm, according to a company news release.

The 41-patient, randomized, double-blind, parallel-group, placebo-controlled European study was designed to measure the effectiveness of 4975 in treating pain induced by surgical repair of an inguinal (groin) hernia as measured one and four weeks after surgery, according to a news release.

Patients were given either a single dose of 4975 or a placebo, which was instilled (dripped by syringe) into the wound over approximately one minute prior to wound closure.

All patients in both the treatment and placebo arms received paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs for one week following surgery, a mandated standard of care in Denmark where the trial was conducted.

"We believe that concomitant administration of pain-killing drugs may have confounded the results of this trial since the results are inconsistent with data obtained from multiple previous phase 2 trials of 4975 that demonstrated significant, sustained pain reduction versus placebo in other indications," said Daniel J. Gennevois, vice president of medical affairs, in the release.

Corgentech, based in South San Francisco, is a biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain management and inflammation.

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