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news.Avicena Group, a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, has reported that its novel Huntington's disease treatment candidate HD-02 demonstrated positive results in a clinical study.
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The open-label, dose escalation study, which evaluated daily administration of HD-02 in doses ranging from 10 to 40 grams, showed that a 30 gram dose provided the optimal levels of efficacy, safety, and tolerability.
The researchers also observed a slower cognitive decline and a sustained reduction in brain atrophy at the 30 gram dose level. These findings demonstrate the disease-modifying potential of HD-02 and provided the rationale for a Phase III study to further evaluate its efficacy at the 30 gram dose, the company said.
Based on these findings, a double-blind, placebo-controlled Phase III clinical trial has been designed to evaluate the 30 gram dose and its ability to slow functional decline. The trial will be sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH). Enrollment is anticipated to begin in the second half of 2008.
HD-02 is a novel drug candidate for the treatment of Huntington’s disease.
Belinda Tsao Nivaggioli, chairman and CEO of Avicena, said: “We are excited about the results of this HD-02 study in Huntington’s disease and are pleased to have identified the optimal dose for further evaluation in next-year’s Phase III trial. We are also pleased to further strengthen our relationship with the NIH via their sponsorship of this trial and look forward to working with the NCCAM within this organization to advance HD-02.”