The company said that almost 80 percent of the patients in the Phase 3 TRILOGY trial have completed randomization in the studies.
Acasti Pharma (NASDAQ:ACST, TSXV:ACST) has announced additional Phase 3 milestones of its TRILOGY trial.
As quoted in the press release:
Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, “Our TRILOGY Phase 3 trials in patients with severe hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to 1500 mg/dL) continue to progress, and we remain on track to report topline TRILOGY 1 results in December 2019, and topline TRILOGY 2 results in January 2020. Importantly, both of our TRILOGY studies have achieved 100% patient randomization, and nearly 80% of the patients in both studies combined have now completed their 6-month plan. It is important to note that data clean up is approximately 90% complete in TRILOGY 1, bringing us closer to database lock. We have also progressed TRILOGY 2 and anticipate database lock as planned in January 2020.”
Jan D’Alvise, president and CEO of Acasti, further noted, “Given the positive results we saw from our Phase 2 trials in a total of 675 patients, we eagerly await the completion of the results from our two TRILOGY clinical studies. It is also important to note:
- patients enrolled in the Phase 3 TRILOGY trials have higher baseline triglyceride levels (above 500 mg/dl) versus our Phase 2 studies, where most had baseline triglycerides significantly below 500 mg/dl;
- patients randomized to CaPre in the Phase 3 TRILOGY trials all received 4 grams per day and will remain on drug for 6 months, while our Phase 2 studies included patients receiving a range of doses from 1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks with a favorable dose response;
- the Phase 2 trials also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C, as well as HbA1c in patients with diabetes.”