By Randall Osborne
Reporting data from a Phase II study that showed HP 228, the company¿s drug for post-surgical pain, statistically reduced morphine use by patients who had hip replacements, Trega Biosciences Inc. is looking for a partner to advance the drug.
Trega¿s stock (NASDAQ:TRGA) reacted to the news, closing Wednesday at $2.375, up $0.812, or 52 percent.
¿We¿re at a stage when we think it would be best to move forward with a partner, and we think we can do that very rapidly ¿ such that the progression can be seamless, basically,¿ said Michael Grey, president and CEO of San Diego-based Trega, adding that potential collaborators have shown ¿significant interest.¿
Eighty-one patients in the double-blind, placebo-controlled study were given placebo or one of three doses of HP 228, which interacts with melanocortin receptors. Patients given the two higher doses used significantly less morphine, compared to patients given placebo.
The study had been designed to evaluate the placebo against five intravenous HP 228 doses in groups who had hip and knee replacements. But the study was stopped at the lower dose range, after an examination of preclinical results. Not enough knee-replacement subjects had been enrolled to determine the drug¿s effect in that group.
Adverse events were consistent with those to be expected after joint replacement and pain management with morphine. Those include respiratory depression and constipation ¿ side effects that may be avoided with HP 228, Grey said.
¿We don¿t have a large enough sample yet to look at that, in any extensive way,¿ he said.
More than 60,000 joint replacements ¿ about half of them hips ¿ are performed annually in the U.S., and the number is expected to rise as the population ages.
HP 228 is the first drug candidate from Trega¿s melanocortin research program to reach the clinical-trial level, but the research has netted major collaborations. Last May, Trega signed a potentially $75 million deal with Novartis AG, of Basel, Switzerland, to use Trega¿s combinatorial chemistry libraries, confirm activity and function of drug candidates, and collaborate with Novartis on preclinical testing. In 1997, Trega entered a $25 million deal with Ono Pharmaceutical Co., of Osaka, Japan, to develop treatments for inflammatory diseases. (See BioWorld Today, May 27, 1998, p. 1, and June 20, 1997, p. 1.)
With Novartis, Trega is exploring the MC-4 receptor¿s role in diabetes and obesity. The agreement with Ono is related to the MC-1 receptor, and the news about HP 228 (which also involves the MC-1 receptor) is particularly encouraging with regard to the Ono deal, Grey said.
¿We¿ve made good progress with [the Novartis and Ono partnerships],¿ he said. ¿We have promising leads. We have good animal data that show, if you have an agonist at MC-4, that can result in weight loss.¿