October 24, 2017

Mitotech Ltd, a UK-based biotechnology company marketing its Dry Eye drug Visomitin® in Russia, announced positive data from their recent study involving a novel Dry Eye model. Dry Eye Disease has been associated with several biological factors including inflammation, decrease in tear quality and corneal damage. Only two active treatments have been approved by the FDA for this disease, both acting as anti-inflammatory agents. Currently there is clear need for a drug that would address other aspects of Dry Eye Disease in its underlying mechanism of action. Throughout several experiments including clinical studies and post-marketing studies Mitotech's lead molecule SkQ1 demonstrated multifactorial effect on signs and symptoms of Dry Eye. In the latest series of studies in rabbits SkQ1 – a small molecule engineered to reduce oxidative stress inside mitochondria – showed versatile effect of SkQ1: corneal staining, tear break-up time (TBUT) and corneal healing rate were significantly improved compared to placebo treatment.

"We have data from clinical studies that demonstrated effect of SkQ1 on a variety of signs and symptoms of Dry Eye Disease. We have very positive feedback from the market in Russia having sold roughly 1 million units to date.", said Natalia Perekhvatova, CEO of Mitotech Ltd "But we always look for new ways to get a deeper insight into biological processes behind this complex disorder so that we could help patients better. Main challenge of this particular work was rooted in developing a new large species model with reliable and natural progression of major signs of Dry Eye Disease over a short time frame. We are glad that the team behind this project selected SkQ1 for their studies and that their work produced positive results. This research project gave us additional confidence in commercialization path we are pursuing in the U.S."

The project was a collaborative effort between several research institutes in Russia including laboratories of the Moscow State University. In one of the studies rabbits were subjected to general anesthesia with a follow-up recovery period. Dry Eye and associated corneal abrasions are typical side effects of such medical procedure. In this experimental model animals developed typical signs of Dry Eye reflecting multifactorial nature of the disease and they were topically treated either with placebo (an artificial tear) or SkQ1 ophthalmic solution. Statistical analysis showed significant benefit of SkQ1 in how quickly animals recover in terms of both corneal staining and TBUT with difference from placebo treatment evident as quickly as hours after the procedure (p-values as low as 0.0005). In a separate series of experiments rabbits were subjected to UV light-induced corneal damage and SkQ1 again was superior to placebo judging by the healing rate of corneal tissue over a course of just one week. Initial results produced by the project were recently published in Oxidative Medicine and Cellular Longevity Journal.

"Developing a drug with innovative mechanism of action that affects a spectrum of pathways at cellular level can be challenging", said Dr. Anton Petrov, COO of the company "We think such research work can be very important in terms of future market positioning as we progress towards pivotal clinical study in the U.S.".

About Mitotech Ltd

Mitotech Ltd is a UK-based biotechnology company developing novel drugs for the treatment of predominantly age-related disorders. The core technology behind Mitotech products is based on a novel class of small molecules – mitochondria targeting cardiolipin peroxidation inhibitors. Company's lead compound SkQ1 is being developed in several drug formulations covering a variety of therapeutic areas with major focus on ophthalmology and neurodegenerative diseases. Mitotech successfully completed Phase 2 clinical study for Dry Eye indication in the U.S. with other indications also approaching clinical stage of development.