Update on Status of Phase II Clinical Trials: Patient recruitment for COLT trial completed
Acasti continues to make good progress on its two Phase II clinical trials, designed to evaluate the effect of different daily doses of CaPre ® on patients with high to very high triglyceride levels. Patient recruitment for the open-label, dose ranging study (COLT) has now been completed and a final report is projected for this summer. Results for the double blind, placebo controlled study (TRIFECTA) are expected to be available during the first half of 2014.
Fiscal Year Milestones
- Made significant progress in the clinical development of Acasti's drug candidate CaPre ®. To date, interim results of the COLT study confirm Acasti's confidence in CaPre's ® potential success, including an important and statistically significant triglyceride reduction as compared to standard of care. In addition to lowering triglycerides, Acasti's longer term objective is to also see the ability of CaPre ® to lower LDL (bad cholesterol) levels, while elevating HDL (good cholesterol), all of which are key in the management of chronic cardiovascular diseases. Moreover, a blind interim analysis in the TRIFECTA trial reported no safety concerns, indicating that CaPre ® is a safe product.
- Continued to move forward to finalize plans for an Investigational New Drug filing with the U.S. Food and Drug Administration (FDA) for a Phase III clinical study in the USA.
- Expanded the commercialization of Acasti's medical food product Onemia™. Voluntary surveys conducted with the medical community have shown encouraging information regarding Onemia's™ efficacy in treating various cardiovascular conditions.
- Invested strategically, announcing intention to make Acasti royalty free. Being royalty free under the license granted by Neptune would allow Acasti to preserve cash of at least $700,000 annually during the term of the licence, which is the current minimum royalty payment. It should also bring more flexibility and strength in negotiating deals with potential business partners and remove a valuation overhang.
- Extended investor base and international presence by listing on the NASDAQ Capital Market.
"As we build on past successes and lay the groundwork for future growth, Acasti's position grows stronger and more promising each year," said Harlan Waksal, Executive Vice-President, Business & Scientific Affairs. "Going forward, we will continue to expand our presence in the biopharmaceutical market by investing strategically in R&D, protecting our intellectual property and building out our business to cement Acasti as a leader of pharmaceutical omega-3 phospholipids."