Exploratory Phase 2 Results of Combination Oral Therapy for Alzheimer’s Justify Further Study

Exploratory Phase 2 Results of Combination Oral Therapy for Alzheimer’s Justify Further Study
Pharnext  is reporting positive Phase 2 results from its investigative pleodrug PXT-864, a new oral combination of existing therapies, for the treatment of Alzheimer’s disease. Results from the exploratory study were presented at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) meeting, held recently in San Diego. PLEODIAL-I (NCT02361424) was a Phase 2, 12-week preliminary efficacy study of several doses of PXT-864 (a fixed combination of acamprosate and baclofen at low dose) in 45 treatment-naive patients with mild AD, accessing the drug's safety and possible effects on cognitive impairment. Patients received the active drug for four weeks, followed by four weeks of placebo, and, finally, another four weeks with PXT-864. Patients then moved to PLEODIAL-II (NCT02361242) for another 24 weeks, and continued on their prior PXT-864 dose. During the last 12 weeks of this study, they were co-treated with donepezil 5 mg. Results presented showed that treatment with PXT-864 was safe and well-tolerated, with no serious adverse reactions observed. Data also suggested that the drug may slow progression of cognitive disability in mild AD patients, as measured by decline in the AD Assessment Scale Cognitive Subscale test (ADAS-Cog-11). Researchers reported that pooled data from PXT864-treated patients, as compared to historical placebo, appeared to show lesser decline. PXT-864 use alongside donepe
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *