Shares of Acasti Pharma Inc ACST, which closed at $2.18 Friday, have entered penny stock territory after a negative data readout.
Placebo Effect Impacts Acasti's Results
Acasti released topline results Monday from a Phase 3 study dubbed TRILOGY 1 that evaluated its lead candidate CaPre, or omega-3 phospholipid, for the treatment of hypertriglyceridemia.
The experimental drug did not achieve statistical significance in meeting the primary endpoint.
This was due to unusually large placebo effect, according to the company.
CaPre reduced triglyceride by 30% from the baseline at 12 weeks and by 36.7% at 26 weeks, the company said.
The control arm receiving placebo showed a 27.5% mean reduction in triglyceride levels at 12 weeks and a 28% mean reduction at week 26.
Patients receiving CaPre while on background statin therapy showed a 42.2% mean reduction in triglyceride at 12 weeks compared to 31.5% for the control arm.
Acasti said it is investigating several scenarios to understand the unexpected placebo response in the TRILOGY 1 study.
The company is scheduled to report results of all of the secondary and exploratory endpoints by the end of the first quarter.
Updating on the TRILOGY 2 study, Acasti said the last patient completed their final visit last week. It now expects a delay in the release of topline results of the trial, with the data readout rescheduled for mid-February.
Amarin Gains As Rivals Fail
Acasti's CaPre is a rival drug to Amarin Corporation plc AMRN's Vascepa, which was approved for hypertriglyceridemia in 2012.
Shares of Amarin, which received a label expansion for Vascepa in December, were moving in sympathy Monday.
Amarin's rally is also partly attributable to an announcement from AstraZeneca plc AZN that it is ending a Phase 3 study dubbed STRENGTH that evaluated its Epanova, or omega-3 carboxylic acids, following recommendation from an independent Data Monitoring Committee that concluded the experimental drug has a low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease.
Acasti shares were down 65.14% at 76 cents at the time of publication Monday,
At last check, Acasti shares were plunging 73.22% to 58 cents, while Amarin shares were adding 5.33% to $19.96.
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