Disappointing results for its lead product candidate CaPre have led Mackie research capital analyst André Uddin to place Acasti Pharma (Acasti Pharma Stock Quote, Chart, News TSXV:ACST) under review.
This morning, Acasti reported topline results for Trilogy 1 Phase Three trail of CaPre that saw the company miss the primary endpoint due to an unexplained high placebo effect.
“First, we wish to thank the physicians, study professionals, and of course the 242 patients who dedicated their time to participate in this trial,” CEO Jan D’Alvise said. “While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic OM3 hypertriglyceridemia trials. Several hypotheses are being investigated now by our clinical team, and by our CRO and Dr. Mozaffarian. These avenues of investigation are being carefully and rigorously pursued, and we are moving as quickly as possible to try to gain understanding and insight into the large and unexpected placebo response seen in Trilogy 1. The company will continue to provide updates on this investigation, as well as top-line results for Trilogy 2 as we get them, to be followed by all secondary and exploratory end points for Trilogy 1 and 2 once the Trilogy 2 study is completed and fully analyzed.”
Uddin today gave his take on the top-line results.
“The high placebo response in TRILOGY-1 came as a surprise to us as cardiovascular trials normally do not usually have this issue (based on our historical experience),” the analyst said. “Comparing absolute TG reduction numbers, we noticed CaPre (30.5%) should be noninferior to Vascepa (27%), Epanova (31%), Omtryg (24.7%) while Lovaza (44.9%) seems to be slightly better. Investors should note that all other Omega-3 trials used oil (potentially negative on TG) as a placebo while TRILOGY-1 used cornstarch (neutral on TG). It is a shame that the high placebo response in TRILOGY-1 made the difference between CaPre and placebo non-significant. We are expecting ACST’s full audit of the trial and TRILOGY-2 results to provide better clarity as to what caused such a high placebo effect. ACST could possibly run a third Phase 3 study, which should not take long, to support an NDA filing if TRILOGY-2 (2nd Phase III trial) results are positive.”
In a research update to clients today, Uddin changed his rating on Acasti Pharma from “Speculative Buy” to “Under Review” and removed his previous target of $2.85.
The analyst did leave the door open a crack on the future of the drug.
“We believe there are still reasons to argue the negative TRILOGY-1 results were not due to CaPre per se, as it demonstrated decent efficacy in TG reduction,” he said. “There is still a chance that CaPre could make it through to a regulatory application if another Phase 3 trial is run – if the TRILOGY 2 trial is successful. For these reasons, we are currently putting ACST Under Review until we see a new path forward for CaPre. We are not recommending a target price at this time.”