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news.Neurotune, a Swiss biopharmaceutical company, has presented positive top-line results from its phase IIa, safety and tolerability, study of dimiracetam (NT-11624), for treatment-induced neuropathic pain in HIV patients receiving anti-retroviral medication.
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The eight week randomized, double-blind, placebo-controlled, parallel group trial enrolled 116 patients at six sites in South Africa and was designed to assess the safety, tolerability, and exploratory efficacy of dimiracetam in patients under polytherapy for HIV.
Dimiracetam was given twice daily, starting at a dose of 400 mg and, contingent on tolerability, doubling to 800mg b.i.d. for two weeks and then 1600mg b.i.d. for four weeks.
Dimiracetam was shown to be safe and well tolerated, with 116 patients randomised in the study and 111 patients who reached and maintained the highest dose to the end of the study with no safety concerns.
The Visual Analogue Scale (VAS) and the Total Symptom Score (TSS) were the main tools used to assess the improvement in symptoms after treatment, from baseline to week eight.
Neurotune chief medical officer Ruggero Fariello said that the data is extremely valuable, dimiracetam has demonstrated excellent safety in a patient population receiving multiple treatments and known for their frailty and susceptibility to multiple complications.
"In addition, we have obtained very useful efficacy data; despite the fact the study was specifically geared to assess tolerability. We have also gained a good insight on the proper design for the forthcoming efficacy study," Fariello said.