Synergen will stop Phase III testing of its Trofak wound healerin diabetic leg ulcers because the drug shows no significantbenefit in an interim analysis of the number of healed vs. non-healed wounds, the company announced Tuesday.
The company's stock (NASDAQ:SYGN) dropped $2 on the news,to $66.
Treated patients in Synergen's second Phase III trial showedthe same benefits from Trofak as patients in the company'sfirst Phase III trial. However, placebo patients in the secondtrial had a higher rate of wound healing than placebo patientsin the first trial. "That's where the statistical significancedisappeared," said Synergen spokeswoman Debra Bannister.
Synergen doesn't yet have data on a second clinical end point,wound closure, but Bannister said it was unlikely that thecompany would file for marketing approval based on that. Ifthe data look good, the company might set up a Phase III trialto study the number of days it takes to heal, Bannister said.
Analyst Margaret McGeorge of Sutro & Co. called the failure a"minor setback" that won't offset "the excitement" over thecompany's Antril drug to treat septic shock.
Trials of Trofak in healing other types of wounds, such asburns, surgical incisions and pressure sores, are still beingconsidered.
Synergen will continue development of the drug's activemolecule as a neurotrophic growth factor for repairing braindamage in a collaboration with Syntex Corp., Bannister said.
The Boulder, Colo., company expects to start clinical testing ofthe active molecule in Parkinson's disease and stroke by thefirst half of 1992, she said.
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