Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) is on track to report topline results from two Phase 3 trials of its lead drug candidate in December 2019 and January 2020.
The company is undergoing trials of its lead drug candidate CaPre, an omega-3 phospholipid derived from krill oil used to treat severe hypertriglyceridemia. The trials, TRILOGY 1 and TRILOGY 2, have achieved the necessary milestones to give Chief Operating and Chief Science Officer Pierre Lemieux confidence that topline results will arrive on schedule.
“Importantly, both of our TRILOGY studies have achieved 100% patient randomization, and nearly 80% of the patients in both studies combined have now completed their 6-month plan,” Lemieux said.
READ: Acasti Pharma awarded $750K by Canadian government to help develop flagship drug candidate CaPre
The results will include a readout of the primary endpoint of the trials: the ability of CaPre to lower triglycerides after 12 weeks compared to a cornstarch placebo. The data will also include safety and tolerability figures, such as adverse events and any discontinuation.
“Given the positive results we saw from our Phase 2 trials in a total of 675 patients, we eagerly await the completion of the results from our two TRILOGY clinical studies,” CEO Jan D’Alvise said. “Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to provide an attractive alternative to current therapies, and thus improve the lives of the millions of patients with cardiometabolic disease.”
In contrast with its Phase 2 trials, patients in the TRILOGY trials had higher baseline triglyceride levels. All patients received 4 grams of the drug per day, as opposed to prior trials, which varied dosage by patient.
Following the second batch of topline results in January, the Laval, Quebec-based company plans to report secondary endpoints of the study. These include reduction of triglyceride levels after 26 weeks, a measure of CaPre’s persistence of effect, and reduction of triglyceride levels across subgroups, a measure of its consistency of effect.
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