Mitotech S.A, a Luxembourg-based clinical-stage biotechnology company developing novel small molecules targeting mitochondria, today announced completion of first patient visit in VISTA-1 - its U.S. Phase 2b/3 clinical trial of SkQ1 compound in patients with moderate to severe Dry Eye Disease (DED). SkQ1 - company's lead compound – belongs to the class of cardiolipin peroxidation inhibitors that Mitotech is developing for treatment of age-related disorders. This is a unique and novel class of molecules targeting mitochondria and designed to protect cells from oxidative stress caused by mtROS. Company's most clinically advanced formulation is Visomitin® – ophthalmic solution of the lead compound developed for several age-related eye disorders, including DED.
"We are very excited to open this new chapter of clinical development for our lead drug candidate”, said Natalia Perekhvatova, Chief Executive Officer of Mitotech S.A.. “Development of a drug platform with innovative mechanism of action is certainly a challenging process, and I am happy that our team reached this important milestone. We are looking forward to receiving results of the study in the second quarter of 2019 and if the study is successful, Visomitin may become a significant first in class treatment option for patients suffering from DED.”
VISTA-1 is a multi-center, randomized, double-blind, placebo-controlled clinical study involving three treatment arms: two concentrations of SkQ1 and placebo, administered BID. Approximately 450 patients will be enrolled in the study across multiple centers in the U.S. and will receive treatment over a 2-month period. VISTA-1 aims at confirming positive effect of SkQ1 on both signs and symptoms of DED observed in previous clinical studies conducted by Mitotech. The study is also designed to confirm excellent safety, tolerability and comfort profile of the drug observed during previous studies and during patient experience in Russia, where the drug has been marketed since 2012.
Mitotech S.A. initiated VISTA-1 as part of its co-development partnership with Essex Bio-Investment, a wholly owned subsidiary of Essex Bio-Technology – a company listed in Hong Kong (Stock code: 1061.HK) with a research and development centre and production plants in China.
"We are truly delighted to be part of this exciting journey and the celebrations of VISTA-1 achieving an important milestone of First Patient First Visit”, said Malcolm Ngiam, President of Essex Bio-Investment. “We look forward to SkQ1 demonstrating its novel mechanism of action and efficacy as a first-in-class ophthalmic solution for DED patients."
More information about VISTA-1 clinical trial will be available at www.clinicaltrials.gov soon.
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.