Acasti strengthens IP position for krill-derived rival to GSK's Lovaza
The Canada-based company will add Australia and Taiwan to its patent portfolio, which currently includes the US, China, Mexico, Saudi Arabia, Panama and South Africa. The granted patents are valid until 2030.
CaPre is a highly purified omega-3 phospholipid concentrate derived from krill oil. The candidate is being developed to treat severe hypertriglyceridemia, a condition that contributes to enhanced risk of pancreatitis and cardiovascular disease.
It has successfully completed two Phase I and two Phase II (here and here) clinical trials and Acasti is preparing to undertake a Phase III trial in late 2017.
“Unmet medical need”
“Market research…suggests there is a significant unmet medical need for an effective, safe and well-absorbing omega-3 therapeutic that demonstrates a positive impact on the major blood lipids associated with cardiovascular disease risk,” Acasti told In-PharmaTechnologist.
Unlike approved therapies GSK’s Lovaza and AstraZeneca’s Epanova, which can increase LDL-C (‘bad’ cholesterol) in patients with severe hypertriglyceridemia, CaPre’s Phase II trials demonstrated no deleterious effect on LDL-C. “…The Phase II data indicated that CaPre may potentially reduce LDL-C”, said Acasti.
Enhanced Bioavailability
According to the firm, CaPre’s omega-3s (EPA and DHA) encourage easy absorption into the body. These omega-3s are either ‘free’ or bound to phospholipids, which enhance bioavailability and EPA and DHA blood levels, when compared to esterified fish-oil omega-3 options.
In a bioavailability comparison study, CaPre demonstrated better bioavailability than Lovaza, as measured by blood levels of omega-3 fatty acids. “The bioavailability of CaPre is not significantly reduced when taken with a low-fat meal versus a high-fat meal. This could represent a significant clinical advantage for CaPre because many physicians recommend patients with hypertriglyceridemia follow a low-fat diet,” Acasti told us.
While Acasti is working to develop and commercialize CaPre for the US market, the company hopes to sell it elsewhere and is pursuing patent applications with similar claim sets globally.
A new drug application (NDA) is dependent upon the successful completion of the Phase III trial. A timeline for the NDA has not yet been fixed.
Acasti is seeking a partner for late-stage development and commercialization of CaPre.
