Corgentech's 4975 demonstrates significant pain reduction after knee-replacement surgeries

By E. Janene Geiss

Philadelphia, June 14 - Corgentech Inc. reported Wednesday positive, top-line clinical data from a phase 2 clinical trial in total knee-replacement surgeries showing that 4975, the company's novel, long-acting, non-opioid drug candidate being developed for site-specific, moderate-to-severe pain, demonstrated pain reduction at all pre-specified time intervals in the study, including statistically significant pain relief the first day.

The difference in average daily pain scores between the 4975-treated group and the placebo group on day one was statistically significant and showed a relative difference in pain on first ambulation of 24%, according to a company news release.

On a numerical rating scale of zero to 10, the average pain score for the treated group was 5.4 compared with the placebo group's average of 7.1, officials said.

It is noteworthy that this difference was detected despite all patients being on concomitant morphine, the company said.

On day 14, the patients' "worst pain in the previous 24-hour period" using the Brief Pain Inventory form showed a relative difference of 34% with the average pain scores being 3.9 and 5.9 for the treated group and placebo group, respectively, officials said.

The analysis of additional exploratory efficacy endpoints favored the 4975 group over the placebo group including average daily pain scores at multiple time points.

In addition, the measure of pain interference with activities favored the 4975 group over the placebo group at most of the time points measured. The preliminary data showed that 4975 was safe and well-tolerated, officials said.

The phase 2 study involved 50 knee replacement surgery patients who were randomized to receive either a single dose of 4975 or a placebo, which was dripped by syringe into the wound prior to closure. Post-operatively, patients self-administered intravenous morphine via patient controlled analgesia pump to achieve satisfactory analgesia.

The company also reported that in a phase 2 trial of 4975 in 44 patients undergoing cholecystectomy, or gall bladder removal, surgeries, the trial did not show a difference in pain scores between those receiving 4975 and those receiving a placebo.

The patients were randomized to receive either a single dose of 4975 or a placebo, which was dripped by syringe into the surgical wound prior to closure, and both treatment groups received concomitant pain medications.

Preliminary data show that 4975 was safe and well-tolerated in this study.

While both the knee and cholecystectomy trials were in surgical settings and included similar concentrations of 4975, it is possible that the extent of contact between the drug and the relevant tissues in the cholecystectomy surgeries may not have been maintained at a level sufficient to provide therapeutic benefit, officials said.

In future trials, the company said it will continue to explore additional routes of administration that will enable optimal drug distribution, including direct injection into the relevant tissues.

Corgentech is a South San Francisco, Calif., late-stage biopharmaceutical company.

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