Synnerva Ltd is a privately held, early stage pharmaceutical company focused on the development and commercialization of proprietary CNS drugs composition allowing significant reduction of the effective doses and elimination of side effects.
Nearly all CNS medications cause side effects that vary in their severity: depression, increased anxiety, uncontrolled movements of the body, dizziness, hallucinations, extreme pain, orthostatic hypotension and syncope and in some cases loss of sight. These side effects are sometimes more harmful than the condition the patients for treated for. Furthermore, many CNS medications lead to medication tolerance requiring continuing increased doses that lead to worsening side effects.
We at Synnerva have developed a new technological platform for the concurrent increase of CNS efficacy while dramatically reducing their side effects. RVX’s method is based on a combination of generic, FDA approved API's with stimulators of vagal afferents.
Our proprietary compositions of CNS drug (Levodopa for Parkinson’s disease, Morphine, Amitriptyline for pain, Valproate for epilepsy, etc) in low or sub-therapeutic doses with sub-therapeutic doses of glutamate antagonists and/or adrenomimetics leads to unusual synergistic enhancement of a therapeutic effects of CNS drug that is not accompanied with side effects.
PROOF OF CONCEPT
Our concept has been proven in animal models validated for appropriate clinical indications. Some of examples of the drugs improvement include:
COMPANY’S PORTFOLIO OF DRUGS IMPROVED BY OUR COMPOSITIONS IN VIVO
• SODIUM VALPROATE,
• SIGNIFICANT DECREASE OR ELIMINATION OF SIDE EFFECTS ;
• CLEAR SYNERGISTIC EFFECT;
• LOWERING THE MINIMAL EFFECTIVE DOSE OF EXISTED DRUGS BY 2-250 TIMES.
Each composition is a new therapeutic entity and is unique for each of drugs and clinical indication.
Two PCT applications have been filed, protecting methods and compositions for potentiating of a number of CNS drugs. Three additional applications are in preparation.
The technology utilizes FDA approved API's, thus the company is exploring registration via the 505(b)(2) new drug application, which relies in part on data from existing reference drugs. This route will enable Synnerva to achieve FDA approval significantly shorter than a new molecule based-drug entity with fewer required number of clinical trials and at a much lower cost.
NEW PRODUCTS DEVELOPMENT PROGRAM INCLUDES:
Regulatory status confirmation - FDA;
Formulation design and manufacturing;
Prototype creation and feasibility testing;
PK, PD tests;
Toxicity study - FDA agreed program;
Vladimir Ritter, Ph.D – CEO, CTO - Brings more than 20 years of experience in all areas of pharm product development. Inventor of the concept and technology for two products for wound healing, Polyhealtm and Polyheal Micro. Vladimir was founder and CTO of company Polyheal from the inception up to a big pharma company worldwide licensing deal. Founder of Synnerva ltd and Pharmapea ltd.
Mrs. Valeria Rukhman, Ph D - R&D manager - Graduated from the chemistry department of Technion - Israel institute of technology. 15 years of experience in pharmaceutical QC laboratory. Experience of working in CGMP environment under international regulatory guidelines including management of laboratory staff, contacts with suppliers, internal and external customers, experimental design, writing analytical methods, protocols and reports.
Scientific advisory board
Prof. Peter A. Lewitt, MD - Directs the Parkinson’s Disease and Movement Disorders Program at Henry Ford Hospital in West Bloomfield, Michigan and is professor of neurology at Wayne State University School of Medicine. In addition to extensive experience in conducting clinical trials for Parkinson’s disease and other neurological disorders, his research interests have included pre-clinical models and biomarkers of neurological disease, pharmacokinetic analysis of neurological drugs, and gene therapy. He is the author of more than 300 publications in basic and clinical neuroscience.
Prof. Tanya Gurevich, MD - Director of parkinson's disease and neuroautonomic service at the movement disorders unit, tel aviv sourasky medical center, faculty member at the sackler school of medicine, tel aviv university. Reviewer of various scientific journals, and a member of the tel aviv sourasky medical center ethics committee.
Prof. Jacob Giris, MD, Phd – Director of internal medicine f and head of the autonomic research center at tel aviv sourasky medical center (“ichilov”). He is also professor of medicine and physiology of the faculty of medicine at tel aviv university. His areas of research include regulatory mechanisms of the cardiovascular system in health and disease, the autonomic nervous system.
Vladimir Ritter, CEO
E mail : firstname.lastname@example.org
P.O. Box 1252, Nazareth Illit 17111, Israel