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news.Epix Pharmaceuticals has reported compelling top-line results from a Phase IIa two-week clinical trial of its novel 5-HT4 agonist, PRX-03140, in patients with Alzheimer's disease.
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The results show that patients receiving 150mg of PRX-03140 orally once daily as monotherapy achieved a mean 5.7 point improvement on the Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS-cog) versus a 0.2 point worsening in patients on placebo. Patients on a 50mg dose of PRX-03140 showed a 1.1 point improvement on the ADAS-cog. The ADAS-cog endpoint is the current standard for evaluating drug efficacy for cognition in Alzheimer’s disease and is an established and accepted registration endpoint.
This Phase IIa clinical trial was a randomized, double-blind, placebo-controlled study to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept) in patients with mild Alzheimer’s disease. PRX-03140 appeared to be well tolerated alone and in combination with donepezil (Aricept) with no serious drug-related adverse events.
The results show that patients on PRX-03140 alone achieved a statistically significant improvement in ADAS-cog; ADAS-cog changes in the combination arms of the trial were not statistically significant.
The Phase IIa clinical trial was conducted across 17 US sites and included 80 patients who were treated for two weeks. Patients were studied on PRX-03140 alone (across three dose arms of 10 patients each: 50mg once-daily, 150mg once-daily and placebo) or in a placebo-controlled combination with 10mg donepezil (Aricept) (across five dose arms of 10 patients each: PRX-03140 at 5, 25, 50, 100 and 200mg with donepezil (Aricept) 10mg once-daily). Primary endpoints were safety, tolerability and assessment of quantitative electroencephalograms (qEEG). A battery of cognitive measures, including ADAS-cog assessment, and pharmacokinetic evaluations were measured as secondary endpoints.
Michael Kauffman, CEO of Epix Pharmaceuticals, said: “We look forward to initiating a larger Phase IIb clinical trial early next year to further explore the potential of PRX-03140.”