Micro-cap biopharma Acasti Pharma Inc (NASDAQ: ACST) issued an update regarding a delay in a clinical readout.
Shares came under significant selling pressure mid-session Monday, losing roughly 60% at one point.
Acasti said late Monday it's postponing the release of top-line results for the TRILOGY 1 pivotal Phase 3 study of CaPre to January, citing an unexpected delay in data processing and transfer from the central testing laboratory to the statistical consultants for independent and external validation.
Earlier, the company had a December timeframe for the readout, while results from the second Phase 3 study dubbed TRILOGY 2 was due in January.
CaPre, a highly purified omega-3 phospholipid concentrate derived from krill oil, is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis.
Company Underplays The Delay
Acasti is a single-trick pony, having only one drug in its pipeline.
The company also said it has "no material update to provide at this time beyond the above timing update and independent and external validation exercise that is underway."
The last patient enrolled in the study is expected to complete the final visit in early January 2020, it added.
Acasti said the top-line results will include a primary endpoint, showing the overall impact of CaPre on lowering triglycerides after 12 weeks compared to placebo, as well as safety and tolerability data.
"As previously disclosed, subgroup analyses of certain key secondary (LDL) and exploratory markers (HbA1c) will be dependent on combining results from both studies,and would be expected sometime later in the first quarter of 2020," the company added.
Acasti's stock traded lower by 3.4% to $2.10 per share at time of publication.