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news.Savient Pharmaceuticals has announced that is to terminate its dose-ranging phase II trial of Prosaptide in HIV/AIDS patients as the drug is unlikely to meet the trial's primary endpoint.
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The trial was designed to test the safety and analgesic efficacy of Prosaptide in HIV/AIDS patients with peripheral neuropathic pain.
Following a formal interim analysis, the Data and Safety Monitoring Board (DSMB) recommended that Savient terminate the trial as the analysis indicated, that even if the trial were to continue to its planned end, there would be little chance of attaining statistical significance at the analgesia efficacy endpoint.
“The termination of the Prosaptide phase II study for lack of analgesic efficacy is clearly a disappointment,” said Dr Zeb Horowitz, chief medical officer of Savient. “We now need some time to understand the basis for this outcome and to determine the next potential steps.”
Over the next few months Savient will analyze all the available data from this study and from recently completed preclinical pharmacology studies. When all of the Prosaptide data set has been thoroughly reviewed, Savient will determine whether or not to pursue alternative analgesia indications, or further explore the potential of Prosaptide to treat peripheral neuropathy in HIV/AIDS and other diseases.