April 21, 2014
Mitotech S.A., a Luxembourg-based clinical-stage biotechnology company today announced that it has initiated Phase II clinical trial of SkQ1 compound evaluating safety and efficacy of the molecule in patients with moderate to severe dry eye disease. SkQ1 is a small molecule engineered specifically for reducing oxidative stress inside mitochondria. Previous dry eye preclinical research utilizing Ora, Inc.'s Scopolamine-CAE Murine Model, presented at last year's International Symposium on Ocular Pharmacology and Therapeutics meeting, provided proof of efficacy and guidance on moving into clinical trials.
“This is a significant development step for Mitotech,” said Natalia Perekhvatova, Chief Executive Officer of Mitotech S.A. “SkQ1 is the first mitochondria-targeted antioxidant to reach clinical phase of development for an ophthalmic indication. Results of our animal studies were remarkably positive, suggesting that SkQ1 can be successful in treating several ocular diseases such as dry eye and uveitis, and this Phase II study is our first step in validating those efficacy results at clinical level. Ora's support in regulatory strategy, manufacturing, and preclinical has been invaluable in our development program and we are excited to be using Ora's Dry Eye System including the Controlled Adverse Environment (“CAE”) in the Phase II study.”
Ophthalmic formulation of SkQ1, called Visomitin, already made its way to the Russian pharmaceutical market in 2012 as treatment for dry eye syndrome. SkQ1 is the lead molecule of Mitotech, a Russian drug-development project based at the Moscow State University. Preclinical tests showed very promising results in several animal models of age-related ophthalmic diseases with inflammatory component.
“We are excited to have started our first clinical study in the U.S,” said Dr. Maxim Skulachev, Chief Scientific Officer of Mitotech S.A. “The key idea of the project is the attempt to prevent or treat various age-related diseases by controlling oxidative stress at the level of mitochondria. We have designed a series of new small molecules – mitochondrially targeted SkQ-type antioxidants. We hope that soon new SkQ1 formulations will enter human trials in other age-related indications such as Age-related Macular Degeneration and Alzheimer's.”
More than 25 million American suffer from dry eye, a condition where insufficient tears are produced to lubricated and nourish the eye. It is a chronic and progressive disease that is estimated to continue to grow substantially over the next decade.
About Ora, Inc. Ora is the world's leading independent, full-service ophthalmic CRO and product development firm with offices in the United States and Japan. Over the past 30 years, we helped our clients earn 37 FDA approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects both in the US and internationally. We bring together the world's most extensive and experienced network of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.
About Mitotech S.A
Mitotech S.A. is a Luxembourg-based biotechnology company developing novel drugs for the treatment of age-related disorders. Mitotech S.A. was founded as a spinoff from the bioengineering department of the Moscow State University. The core technology behind Mitotech products is based on the world-renowned work by Professor Vladimir Skulachev in designing mitochondrially addressed antioxidants. Company's lead compound SkQ1 is being developed into several drugs covering a variety of therapeutic areas and methods of administration. Mitotech S.A. designed an extensive preclinical program involving several independent U.S. and European laboratories to support SkQ1 development. Company's IND application for SkQ1 was approved in 2013.