Supported by 1,500 peer-reviewed studies, bertilimumab is a novel personalized therapy that targets and lowers eotaxin-1 levels in many inflammatory conditions . It is being studied to see if it will improve outcomes in patients with diseases that do not have therapies or the therapies have severe limitations.
Bertilimumab is a first-in-class monoclonal antibody designed to block the protein eotaxin-1, which is responsible for causing inflammation in a significant number of diseases. It is currently in clinical development for bullous pemphigoid, an orphan auto-immune skin blistering disease, IBD (Crohn’s and Colitis) and atopic dermatitis.
Eotaxin-1 causes eosinophils to migrate toward sites of inflammation, where they release substances that damage tissue and enhance inflammation. By neutralizing Eotaxin-1, Bertilimumab may prevent the migration of eosinophils, thus helping to relieve inflammatory conditions associated with the protein.
It is important to note that eotaxin-1 is not only the target, but also the biomarker for treatment. Personalized therapies are designed to optimize safety-to-efficacy ratio by selecting patients with higher response rates based on specific biomarkers. Our precision medicine, bertilimumab, may enable the identification and treatment of patients with elevated eotaxin-1, as is found in some autoimmune diseases.
Bertilimumab was developed by Cambridge Antibody Technology (now part of MedImmune, the biologics division of AstraZeneca). Immune took responsibility for product supply and all non-ophthalmic indications in June 2011, while iCo Therapeutics retains the rights to develop any ophthalmic indications.
Phase 2 clinical trials in Bullous Pemphigoid and Ulcerative are currently ongoing in Israeli sites. In additional, we are considering a small Phase 2 trial in Atopic Dermatitis. We are expecting results of the clinical trials and orphan drug designation for BP following Investigational New Drug (IND) clearance from the Food and Drug Administration (FDA).
Nanocyclo is the next generation topical treatment for atopic dermatitis and psoriasis.
Cyclosporin A is a well-known small-molecule widely used to prevent organ transplant rejection. It has also been approved to treat autoimmune diseases such as rheumatoid arthritis and psoriasis, and for local use in the treatment for dry eye and some forms of keratitis.
It is an immunosuppressant drug interfering with the activity and growth of T-cells, which are key in the inflammatory cascade.
The nanoformulation enables the molecule to better penetrate into the skin layers and provide a local action on skin lesions.
The benefit for the patient is to avoid potential effects of systemic cyclosporine A including severe infections and adverse effects on the kidney function.
Immune pharmaceuticals Inc, is partnering with Yissum, Hebrew University of Jerusalem for the development developing a topical formulation of cyclosporine A, which is delivered as a nanoformulation in a cream, to treat atopic dermatitis and psoriasis.
Phase IIa clinical trials are expected to be initiated in 2017.