Mitotech S.A., a Luxembourg-based clinical-stage biotechnology company developing novel small molecules targeting mitochondria, today announced initiation of a U.S. Phase 2b/3 clinical trial of SkQ1 compound in patients with moderate to severe Dry Eye Disease (DED). SkQ1 was engineered specifically for reducing oxidative stress within the mitochondria. Visomitin, a topical ophthalmic formulation of this innovative molecule, is the most advanced product from company's line-up of products developed for treatment of a variety of age-related eye disorders, including DED.
"Very few drugs with truly innovative mechanisms of action reach this stage of clinical development in dry eye”, said Natalia Perekhvatova, Chief Executive Officer of Mitotech S.A.. “We are delighted to release the drug to clinical sites today and we are looking forward to the first visit of our first patient that is planned for this coming weekend. Dry Eye Disease is a significantly underserved indication and our company is hoping that this particular study will help deliver a break-through product to patients suffering from moderate to severe DED. Dry eye is a multifactorial disease that requires treatment featuring multifactorial mechanism of action, which Visomitin has potential to provide.”
Mitotech's previous US clinical study was a Phase 2 trial of Visomitin with 90 patients enrolled at a single center. In that study SkQ1 demonstrated statistically significant superiority over placebo for several endpoints such as fluorescein staining, ocular discomfort and grittiness. SkQ1 was comfortable, well tolerated and there were no unexpected or serious ocular adverse events.
The upcoming Phase 2b/3 study is a multi-center, randomized, double-blind, placebo-controlled clinical study involving three treatment arms: two concentrations of SkQ1 and placebo administered BID. Top line results are expected to be released in the second quarter of 2019.
Mitotech S.A. initiated this pivotal study as part of its co-development partnership with Essex Bio-Technology.
“We share the excitement with Mitotech in initiating the first Phase III clinical trial for both companies in the United States, with both teams putting in hard work in making the trial possible” said Malcolm Ngiam, President of Essex Bio-Investment, “An important milestone for both companies, in particular for Essex Bio-Technology as we are one step closer to operating beyond our main market in China, in the field of Ophthalmology.”
About Mitotech S.A
Mitotech S.A. is a Luxembourg-based biotechnology company developing novel drugs for 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.
About Essex Bio-Technology
Essex Bio-Technology Limited is a bio-pharmaceutical company, started in early 90's, a pioneer in bio-pharmaceutical industry in China, that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF, a basic fibroblast growth factor, with established mechanism of action in cellular proliferation, differentiation and migration. The Company maintains a pipeline of multi-project in R&D and on various stages of clinical programs, of which several projects involving growth factors and antibody and a handful of projects are on unit dose for Ophthalmic and Respiratory disease.