Enzymotec begins 24-month clinical trial of Vayacog in MCI patients

Vayacog is a proprietary prescription medical food that offers phosphatidylserine enriched with DHA, a lipid composition essential to manage key biochemical modifications underlying losses in brain function.

The drug is designed for the dietary management of lipid imbalances associated with early memory impairment.

Enzymotec division VAYA Pharma CEO Robert Crim said: "The initiation of this long term study is another critical step in building the pyramid of evidence to validate the use of Vayacog for the dietary management of MCI, which affects over 10% of adults over 65 and is often debilitating to their families as well.

"Vayacog is already considered an important option to manage MCI. We expect this clinical study will provide further learnings on its impact over an extended period."

The 24-month, multi-center, randomized, double-blind, placebo-controlled trial has enrolled 360 patients in the US and Israel.

The trial is designed to study the effect of Vayacog versus placebo on cognitive abilities, using the selective reminding test as the primary outcome.

Enzymotec head of VAYA Pharma Research Center Dr Yael Richter said: "Vayacog’s safety and short term efficacy in non-demented subjects with memory complaints was demonstrated in an earlier clinical study.

"By extending the timeframe of the current study over a two-year period, we expect to uncover important complementary perceptions related to the long term efficacy of Vayacog in managing MCI.

"Currently there is no formal approach for managing MCI and we hope to be able to deliver statistical data that result in Vayacog becoming the standard protocol."