Acasti Pharma Inc., a Neptune Technologies & Bioressources Inc. NEPT
subsidiary, announces a clinical study update and announces the first ever
human data of safety and efficacy of its patented prescription drug candidate
CaPre®.
Acasti has achieved significant progress in the two presently ongoing clinical
studies. The registrational phase II double blind placebo controlled clinical
study has completed its first of two interim analysis. The review committee
assembled to evaluate the progress of the study reviewed the interim analysis
relative to drug safety and efficacy, and agreed, unanimously, that the study
should continue as planned. All committee members were convinced that there
are no concerning toxicity issues and that the signals of possible CaPre^®
therapeutic effect, noted as reduction of triglyceride in the groups
evaluated, were reassuring and clinically significant to allow the further
continuation of the study. As it is customary, the data was provided to the
committee members blind, meaning that the identity of the three groups was not
revealed. Since the data showed no safety concerns and a strong clinical
signal the decision was made, by the committee, that it is safe to continue
the study and that there is no need to unblind the data.
The second phase II open label clinical study should be completed by the end
of the first quarter of 2013. It has been delayed due to the need for further
patient recruitment after the approved clinical trial amendment to add an
additional 4g/day CaPre® treatment group, following a FDA recommendation to
evaluate the effect of a 4g dose. Acasti was able to obtain completed clinical
data from a cohort of patients that completed an eight-week treatment with 2g
CaPre® per day, which will not be included in the primary analysis under the
amended protocol. Test results of 23 patients were analysed of whom 19 had
baseline triglyceride levels between 204 and 476mg/dl. The data showed a
statistically significant 25% (p<0.05) reduction in triglycerides after eight
weeks of treatment. Besides the important decrease in triglycerides, CaPre®
also decreased Low Density Lipoprotein (LDL), Very Low Density Lipoprotein
(VLDL) and non-HDL lipids and increased High Density Lipoprotein (HDL).
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