Mitotech and Essex Bio-Technology Announce Enrollment in VISTA-2 - a Pivotal Phase 3 Clinical Study of SkQ1 for Dry Eye Disease
Mitotech S.A., a Luxembourg-based clinical-stage biotechnology company developing novel pharmaceuticals targeting mitochondria, announced enrollment of first patients in its U.S. Phase 3 study VISTA-2 building on positive results of VISTA-1 clinical study (a U.S. Phase 2b/3 study) of SkQ1 compound in patients with moderate to severe Dry Eye Disease (DED). SkQ1 belongs to the class of cardiolipin peroxidation inhibitors that Mitotech is developing for treatment of a spectrum of age-related disorders, including DED.
“In a rare case for Dry Eye Disease data that came out of VISTA-1 delivered a clear message”, said Natalia Perekhvatova, Chief Executive Officer of Mitotech S.A. “VISTA-1 results revealed early onset of action of SkQ1 for a spectrum of clinically relevant symptoms and signs such as Ocular Discomfort and Fluorescein Staining. Combined with excellent drug tolerability profile this positions SkQ1 as an important potential treatment option for Dry Eye Disease patients worldwide.”
VISTA-1 was a multi-center, randomized, double-blind, placebo-controlled clinical study involving three treatment arms: two concentrations of SkQ1 and vehicle, administered BID. Approximately 450 patients were enrolled in the study across multiple centers in the U.S. and received treatment over a 2-month period. Nominal co-primary endpoints of the study (fluorescein staining in central corneal zone and grittiness) were not met, but multiple predetermined secondary endpoints demonstrated broad action of SkQ1 in the intent to treat (ITT) population. Relative to the vehicle (an artificial tear) SkQ1 demonstrated statistically significant reduction of Ocular Discomfort (p<0.05) as early as after 4 weeks of treatment with multiple symptoms in 4-Symptom Questionnaire also demonstrating statistically significant reduction (p<0.05), all in ITT population. A global clinical sign - conjunctival fluorescein staining - demonstrated statistically significant improvement vs. vehicle (p<0.05), also in ITT population. At the same time the study highlighted excellent safety profile of the drug with tolerability being statistically similar to that of an artificial tear.
“We are very encouraged by the positive outcome in VISTA-1, supporting our decision to proceed with VISTA-2,” said Malcolm Ngiam, President of Essex Bio-Investment Limited, “We are excited to be able to continue our collaboration with Mitotech S.A. and to move one step closer to making SkQ1 available for the world-wide DED market.”
VISTA-2 is a multi-center, randomized, double-blind, placebo-controlled clinical study, similar in its design to VISTA-1, but involving two treatment arms (SkQ1 solution and vehicle) with twice as many (300) patients per arm.
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.
100% Mitotech S.A. owned by Russian Mitotech LLC, a portfolio company of RUSNANO.
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Essex Bio-Technology is a bio-pharmaceutical company that develops, manufactures and commercializes genetically engineered therapeutic rb-bFGF (FGF-2), having five commercialized biologics marketed in China since 1998. The products of the Company and its 3rd party products are prescribed for wound healing and diseases in Ophthalmology & Dermatology, which are marketed and sold through more than 6,300 hospitals and managed directly by its 42 regional sales offices in China. Leveraging its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects at various clinical stages, covering a wide range of fields of indication.
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SkQ1 addresses DED through a novel mechanism of action, acting on the mitochondria at a cellular level. Unlike current standards of care, which act primarily as anti-inflammatory agents, SkQ1 has been shown to not only relieve inflammation but also improve tissue degeneration and tear quality deficit by targeting oxidative stress within the eye. In VISTA-1 – a Phase 2b/3 clinical study in the United States (NCT03764735) - SkQ1 showed evidence of efficacy in reducing both the signs and symptoms in dry eye subjects.