A Medical Device Daily
Synvista Therapeutics (Montvale, New Jersey) reported that, following a review of its clinical development portfolio and its current financial status, the board of directors and management have determined that it is in the best interest of the company to focus its resources on maximizing the value of its diagnostic assets and to terminate all ongoing clinical trials of its product candidates alagebrium and SYI-2074.
Those trials include:
• The BENEFICIAL study, a Phase II double-blind, placebo-controlled, randomized trial of alagebrium in patients with chronic systolic heart failure.
• The BREAK study, a Phase II double-blind, placebo-controlled, randomized trial of alagebrium in patients with diastolic heart failure.
• The Phase II trial of a topical formulation of SYI-2074 for the treatment of chronic, mild-to-moderate plaque psoriasis in adults.
Each of these trials will be terminated as quickly as possible.
As noted previously, the company has submitted an application for 510(k) clearance for its HaptoChek diagnostic test kit, a protein-based clinical laboratory test to identify patients with Hp2-2 diabetes. The 90-day review process of such submission is ongoing, during which time the FDA will determine whether the kit can be distributed to labs throughout the country as an in vitro diagnostic.
The company is continuing to explore strategic alternatives in order to monetize its technology assets, which may take the form of sales or licensing transactions with respect to those assets. In light of Synvista's cash position and current negative economic and capital markets conditions overall, if the company is unable to enter into such transactions in a timely manner, the company's ability to continue operations beyond 2Q09 is in doubt.