I guess it is finished Acasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyceridemia
CaPre achieved a 30.4% median reduction in triglycerides at 12 weeks and 38.4% at 26 weeks, but did not achieve statistical significance for the primary endpoint
LAVAL, Qubec, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.
The Company reported a 30.4% median reduction in triglyceride levels among all patients receiving CaPre, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks (the Primary Endpoint), as compared to 27.5% in TRILOGY 1. The unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a “p” value of 0.19, which was not statistically significant, and therefore the TRILOGY 2 study did not meet its primary endpoint. As a result, the company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.
CaPre was well tolerated in TRILOGY 2, with a safety profile similar to placebo, and consistent with the Company’s previously conducted Phase 2 and 3 studies.
“Compared to their baseline levels, the observed triglyceride reductions among patients taking CaPre were similar or larger than seen with prior omega-3 therapies,” said Dr. Dariush Mozaffarian, Professor at Tufts University and academic PI of the trial. “However, an unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved. We plan to now pool together the results from the two studies to see if we can better understand this phenomenon in post-hoc explorations. We want to thank all of the investigators for their participation, and Acasti for sponsoring the Trilogy program.”
Jan D’Alvise, Chief Executive Officer of Acasti, stated, “We are very disappointed in the outcome of the Trilogy 2 study. Based on what we have seen in the preliminary topline data, we believe TRILOGY 2 was likely not affected by the same “Pre-Randomization Triglyceride Normalization” effect that we saw in TRILOGY 1. While the triglyceride reduction observed in the control arm was less than what was observed in the Trilogy 1 Study, it still remains one of the highest seen amongst the previously conducted triglyceride reduction studies, and may be explained by the excellent background standard of care that is being provided to these patients today.”
D’Alvise continued, “We extend our sincere gratitude to all of the patients and their families, as well as the investigators who participated in this important trial, and to our employees who have worked tirelessly to develop and evaluate CaPre as a therapeutic for this indication. We especially want to thank Dr. Dariush Mozaffarian, our Principal Investigator, for his expert counsel and support throughout this program. The Acasti team and our clinical advisors will review the full dataset once it is available, and will complete the full data analyses as contemplated in the Statistical Analysis Plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2. Taking into consideration all of the analyses from TRILOGY once completed, we will seek to maximize the value of the CaPre® asset by continuing to explore a range of options available to us.”
The Company has decided not to host a conference call today as previously disclosed, as there is no additional material information at this time that can be shared beyond what is contained in this press release. The Company and its board of directors has been and will continue to evaluate all strategic options and will provide updates on this process as warranted.