Canadian biotech to discontinue omega-3 program after second PhIII fails on significant triglyceride reduction
It’s been an eventful 12 months or so for the omega-3 market, but one company’s latest attempt to use the approach for severe hypertriglyceridemia came up short.
Canadian biotech Acasti Pharma $ACST reported a second Phase III flop for its omega-3 phospholipid candidate CaPre on Monday, as the trial did not reach statistical significance for its primary endpoint. The company stated that, as a result, it will not file for an NDA in the US nor conduct additional trials for the program.
“We are very disappointed in the outcome of the Trilogy 2 study,” Acasti CEO Jan D’Alvise said in a statement. “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.”
Acasti shares, which were already in penny-stock territory, fell 65% Monday following the news.
The company had been conducting two Phase III trials in parallel, and after Acasti reported that the first study didn’t hit statistical significance in January, a path forward might still have remained had Monday’s results proved more promising. However, that didn’t happen, as both studies saw “unusual” triglyceride reductions in their placebo arms.
Monday’s results (“Trilogy 2”) showed a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks, as compared to 27.5% in the first Phase III (“Trilogy 1”). Also, Acasti reported a 30.4% median reduction in triglyceride levels among all patients receiving CaPre, as compared to the earlier trial’s 30.5% rate.
That led to a p-value of 0.19 for the unadjusted, placebo-corrected triglyceride reduction of 12.4%. Ergo, not statistically significant.
The unusual triglyceride reduction in the first Phase III spurred an audit of five testing sites which Acasti said in February disproportionately contributed to the placebo response. But in the second Phase III, the company believes the trial “was likely not affected by the same ‘Pre-Randomization Triglyceride Normalization’ effect that we saw in Trilogy 1,” D’Alvise said.
Fish oil omega-3 drugs have had their fair share of the spotlight recently thanks to a patent fight between the biotech Amarin and generic drugmakers. After Amarin received a blockbuster FDA approval last December for expanding the use of Vascepa into patients with elevated triglyceride levels, a US District Court invalidated the company’s IP in March.
Soon thereafter, the FDA approved the first Vascepa generic in May, a copy of pure EPA from Hikma Pharmaceuticals. But analysts at the time noted that a Hikma launch was not likely to take place any time soon given the risks of a potential successful appeal by Amarin.