Mimetogen Pharmaceuticals Inc. (“Mimetogen”) today announced positive top line data from a Phase II clinical trial with MIM-D3, its lead drug for the treatment of dry eye. The trial demonstrated statistically significant improvements in signs and symptoms with its low (1%) and high (5%) doses of MIM-D3, together with excellent safety and tolerability profiles. Mimetogen is in the process of completing its analysis of the data, and intends to present further details at a future medical conference.
“These preliminary results are very promising for the use of MIM-D3 for the treatment of dry eye disease” said Garth Cumberlidge, President and CEO of Mimetogen, adding: MIM-D3, a novel growth factor mimetic, represents a potential first-in-class therapy for the estimated $1 billion US market”.
The 150-patient phase II study utilized a controlled adverse environment (CAETM) chamber to measure dry eye patients' ability to withstand a stressful drying environment on the eye, and patient diaries to measure the severity of their dry eye symptoms over the course of the study. Patients were randomized to receive MIM-D3 low dose, MIM-D3 high dose or placebo twice/day over the course of a 28-day study.
Phase II Clinical Trial of MIM-D3 for Dry Eye Disease
Mimetogen’s lead drug candidate for the treatment of dry eye disease, MIM-D3, is a small molecule mimetic of nerve growth factor (NGF). NGF is a naturally occurring protein in the eyes that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production. In contrast to most other products in development or on the market, MIM-D3 is designed to quickly and directly improve the quality of the tears produced by the eyes whilst reducing clinical signs and symptoms such as chronic dryness and grittiness. Dry eye disease is estimated to be a $1 billion US market for which there is currently only one FDA-approved treatment.
The Phase II randomized, double-masked, multi-center, placebo-controlled trial was designed to evaluate the safety, tolerability and efficacy of MIM-D3 in improving both the signs and symptoms of dry eye.