July 19, 2018
Mitotech S.A, a Luxembourg based clinical stage biotechnology company, announced entering a partnership agreement with Essex Bio-Investment for Phase 3 clinical program in Dry Eye Disease. Under the agreement Essex Bio-Investment will fund U.S. clinical program for Mitotech's lead compound SkQ1 with approximately $17m allocated towards the first Phase 3 study starting as early as Fall 2018.
“We are excited to have established a strategic partnership with Mitotech to co- develop SkQ1 on the global stage, through a Phase 3 clinical study in the United States,” said Malcolm Ngiam, President of Essex Bio-Investment, “Mitotech recog nizes Essex Bio-Technology's strong presence in China and the region, with stren gths in research, clinical development and sales, by entrusting us to develop th e product, and we look forward to SkQ1 cementing our position as a leader in Dry Eye Disease and Ophthalmology.”
Mitotech's molecule SkQ1, has been shown to relieve inflammation, tissue degener ation, and tear quality deficit. Unlike the current standards of care, SkQ1 deal s with Dry Eye Disease on a cellular level by protecting the eye from oxidative stress. Oxidative stress – a phenomenon widely evident in patients suffering fro m Dry Eye – happens when the amount of ROS produced inside cells and tissues gro ws beyond normal levels. One of the primary sources of ROS inside cells is an or ganelle called the mitochondria, and SkQ1 has been proven to target and neutrali ze mitochondrial ROS to restore cellular function.
In Russia Mitotech has already won regulatory approval for its eye drop formulat ion of SkQ1, called Visomitin – and about 1 million units of Visomitin have been sold in the Russian market since it was commercially launched.
“We are delighted to enter this collaboration with Essex Bio-Technology, this pa rtnership is a great strategic fit for us as Essex Bio-Technology specializes in ophthalmology, and specifically in treatments for Dry Eye”, said Natalia Perekh vatova, CEO of Mitotech S.A. “Our previous clinical studies in Dry Eye showed th at our drug protected cornea from damage, improved quality of the tear and made patients feel better at the same time. We are getting very positive feedback fro m the Russian market, both from physicians and patients. This new partnership wi ll allow us to jump-start late-stage SkQ1 development in the U.S. If successful in Phase 3 studies, SkQ1 will be the first molecule in the class of mitochondria targeted cardiolipin protectors to reach approval stage in the U.S. We believe this novel approach may provide a safe and effective treatment for Dry Eye by co untering not just one, but several factors of the disease simultaneously.”
Mitotech has previously conducted a 28-day U.S. Phase 2 study of SkQ1 ophthalmic solution in patients with Dry Eye Disease with statistically significant respon se against placebo in several signs and symptoms. The first planned Phase 3 stud y will be designed to confirm those results and the results of Mitotech's clinic al studies in Russia.
Essex Bio-Technology Limited is a bio-pharmaceutical company, started in early 9 0's, a pioneer in bio-pharmaceutical industry in China, that develops, manufactu res and commercialises genetically engineered therapeutic rb-bFGF, a basic fibro blast growth factor, with established mechanism of action in cellular proliferat ion, differentiation and migration.
The Company currently has five commercialised bio-pharmaceutical products, formu lated with rb-bFGF, in China, out of which 3 are approved by CFDA as Category I drugs. The products are being marketed & sold as Beifushu, Beifuji & Beifuxin, f or treatment of ocular surface wounds and topical (skin) surface wounds respecti vely. Beifuji is the first in the world to have obtained approval from CFDA for commercialisation in 1998.
The Company focuses on two main therapeutics; Ophthalmology and Surgical arena o f topical (skin) surface wounds, which primarily covers Dermatology, Stomatology and Obstetrics & Gynaecology, while selectively pursuing therapeutics in Neurol ogy, Oncology and Orthopaedics. The Company maintains a pipeline of multi-projec t in R&D and on various stages of clinical programs, of which several projects i nvolving growth factors and antibody and a handful of projects are on unit dose for Ophthalmic and Respiratory disease.
The Company's products and its 3rd party products are marketed and sold through more than 5,400 hospitals in China and are managed directly by its 39 regional s ales offices with about 1,410 sales and marketing people. Its 3rd party products ; notably are inclusive of Xalacom eye drops and Xalatan eye drops of Pfizer (fo r Ophthalmology), Iodized Lecithin Capsules (for Ophthalmology), Yi Xue An Granu les (for Obstetrics & Gynaecology) and Carisolv Products (for Stomatology).
About Mitotech S.A
Mitotech S.A. is a clinical-stage Luxembourg-based biotechnology company develop ing novel drugs for the treatment of predominantly age-related disorders. The co re technology behind Mitotech products is based on a novel class of small molecu les – mitochondria targeting cardiolipin peroxidation inhibitors. Company's lead compound SkQ1 is being developed in several drug formulations covering a variet y of therapeutic areas with major focus on ophthalmology and neurodegenerative d iseases. Mitotech successfully completed Phase II clinical study for Dry Eye Dis ease in the U.S. with other indications also approaching clinical stage of devel opment.