Navigation Links
Mitotech and Essex Bio-Technology Complete Enrollment in VISTA-2 – a pivotal Phase 3 Clinical Study of SkQ1 for Dry Eye Disease
Date:8/26/2020

Mitotech S.A, a Luxembourg-based clinical-stage biotechnology company developing novel pharmaceuticals targeting mitochondria, in partnership with Essex Bio-Technology, a bio-pharmaceutical company specializing in Ophthalmology and Dermatology, announced completion of enrolment in its pivotal U.S. Phase 3 VISTA-2 study of SkQ1 ophthalmic solution in patients with moderate to severe Dry Eye Disease (DED). SkQ1 belongs to the class of cardiolipin peroxidation inhibitors developed for treatment of a spectrum of age-related disorders, including Dry Eye Disease (DED).

VISTA-2 is a multi-centre, randomized, double-blind, placebo-controlled clinical study involving two treatment arms: SkQ1 ophthalmic solution and vehicle solution, administered BID. 610 patients have been enrolled in the study across multiple centres in the U.S. to receive treatment over a 2-month period.

“We are proud to have reached full enrollment in our pivotal study”, said Natalia Perekhvatova, Chief Executive Officer of Mitotech S.A.” At the same time, we recognize that COVID-19 pandemic is a challenging environment for patients and healthcare industry worldwide. Mitotech and Essex Bio-Technology remain in close contact with medical centres and investigators to ensure the safety of trial participants as well as medical professionals involved in the study. With multiple layers of safeguards in place we are looking forward to completing the study in Q4 2020.”

VISTA-2 is Mitotech’s first pivotal study in Dry Eye Disease designed to confirm outcome of its VISTA-1 study conducted back in 2019. VISTA-1 facilitated dose and primary endpoint selection for VISTA-2 having demonstrated statistically significant SkQ1 impact against vehicle on multiple signs and symptoms of Dry Eye Disease over the 2-month course of treatment. At the same time the study highlighted excellent safety profile of the drug with tolerability being statistically similar to that of an artificial tear.

“Our appreciation to everyone involved for their ongoing efforts in supporting timely completion of study enrolment,” said Malcolm Ngiam, President of Essex Bio-Investment Limited. “We look forward to evaluating the study read-out and to moving one step closer to making SkQ1 available for the world-wide DED market.”

About SkQ1
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.

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.

About Essex Bio-Technology
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 are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology & Dermatology, which are marketed and sold through more than 8,880 hospitals and managed directly by its 43 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 and indications.

Read the full story at https://www.prweb.com/releases/mitotech_and_essex_bio_technology_complete_enrollment_in_vista_2_a_pivotal_phase_3_clinical_study_of_skq1_for_dry_eye_disease/prweb17338977.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related biology news :

1. Mitotech Initiates Phase 3 Clinical Trial of SkQ1 Ophthalmic Solution in Patients with Dry Eye Disease in a Co-Development Effort with Essex Bio-Technology
2. Mitotech and Essex Bio-Technology Announce Enrollment in VISTA-2 – a pivotal Phase 3 Clinical Study of SkQ1 for Dry Eye Disease
3. Teaching complete evolutionary stories increases learning
4. Frost & Sullivan Recognizes TATAA Biocenters Complete, Best-in-Class Services for Analyzing Genetic Material
5. Addiction: Can you ever really completely leave it behind?
6. First look at complete sorghum genome may usher in new uses for food and fuel
7. Biochemists find incomplete protein digestion is a useful thing for some bacteria
8. Treadmill step training promotes motor function after incomplete spinal cord injury
9. Baxter Completes Enrollment In Phase III Clinical Trial Of BAX 855, Extended Half-life Recombinant FVIII For Hemophilia A
10. OU professor receives national fellowship to complete biography on Ancel Keys and the American diet
11. International team completes systematic, genomic study of cervical cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2020)... ... July 08, 2020 , ... Overcoming Comparability ... Regulation, An FDAnews Webinar, Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT, ... is the most effective way to complete one? Will the study comply with ...
(Date:7/2/2020)... ... July 01, 2020 , ... AltruBio Inc. ... of Neihulizumab, a biologic for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD), ... Dr. Paul J Martin of the Fred Hutchinson Cancer Research Center, this single-arm, ...
(Date:7/1/2020)... VENICE, Calif. (PRWEB) , ... July 01, 2020 ... ... focused on building awareness and solutions for glioblastoma—the most common and aggressive adult ... and Lisa Haile, JD, PhD. Senior Fellows are charged with supporting the organization’s ...
Breaking Biology News(10 mins):
(Date:7/31/2020)... SAN FRANCISCO (PRWEB) , ... ... ... fast-growing provider of cloud-based software for the life sciences industry, today announced ... and presentation platform designed specifically for Medical Science Liaisons (MSLs) and other ...
(Date:7/18/2020)... ... July 17, 2020 , ... ... firm for the life sciences and food industries, is pleased to announce that ... Clinical Research – Business Development. , Charles is an accomplished and results-driven sales ...
(Date:7/7/2020)... SAN DIEGO (PRWEB) , ... July 06, 2020 , ... ... a new program featuring up to 200 million stem cells. Depending on the patient's ... of seniors in the US will die having some form of Alzheimers dementia, and ...
(Date:6/28/2020)... (PRWEB) , ... June 25, 2020 , ... The Indoor ... launch of Safe Space™ for businesses of all types to ensure cleanliness, distancing and ... , A Safe Space™ enabled business will provide a health performance index ...
Breaking Biology Technology: