Studies of Lancovutide in Dry Eye Disease

Pre-Clinical Tear Fluid Secretion and Safety Studies in Rabbits

Initial safety of lancovutide in rabbits was demonstrated in single dosing and over seven days of dosing, with six instillations of the dosing solution per day.

Phase I Clinical Trial Results in Healthy Volunteers

A safety study was conducted in Europe in healthy volunteers to assess the ocular and systemic safety and the tear secretion after a single instillation of lancovutide ophthalmic solution. No clinically significant adverse events were reported, demonstrating local ocular tolerance of a single instillation of lancovutide.

Phase I Clinical Trial in Healthy Volunteers

A single center Phase I study was completed in the US to evaluate the safety of two concentrations of lancovutide ophthalmic solution and its matching vehicle placebo formulation. The study, featuring up to 14 days of dosing, with 14 days of follow-up, indicated that multiple doses of lancovutide ophthalmic solution are safe.

Phase II Clinical Trial in Subjects with Dry Eye

A multiple center, vehicle-controlled Phase II study was completed in the US to evaluate the safety of two dosing regimens of lancovutide ophthalmic solution in subjects with mild to moderate dry eye disease.  The study, featuring 28 days of dosing, assessed the safety, tolerability, and efficacy of the two regimens of Mol1901 Ophthalmic Solution.  Review of  these data is ongoing.

Complementary Animal and Human Data

Data acquired from animal studies to date show that administration of lancovutide as an opthalmic solution is an effective way to deliver the drug to the affected organ.  Additionally, data acquired from animal and human studies of a solution of lancovutide for the treatment of cystic fibrosis show that inhalation of lancovutide binds tightly to the cells of the lung lining, offering the possibility of a prolonged duration of action.  Animal studies evaluating both methods of drug delivery show little or no systemic absorption. This profile suggests that the drug will be safe to other organs and body systems, while offering direct benefit to the target organ, the eye and its mucosa.