NEW DELHI – Glenmark Pharmaceuticals SA, a Swiss subsidiary of Mumbai, India-based Glenmark Pharmaceuticals Ltd., completed phase I trials in the Netherlands of BBR 830, a monoclonal antibody (MAb) that targets a class of activated immune cells that are involved in several autoimmune disorders.

The company now expects to launch phase II trials over the next few months in the U.S. and Europe to test the antibody in atopic dermatitis (AD) and celiac disease.

AD, characterized by itching, scratching and relapsing lesions, is prevalent in as many as 1 percent to 3 percent of adults and up to 20 percent of children. Applying skin ointments or lotions mostly fails to control the disease. To date, there are only two approved treatments for AD. One is prednisone, a synthetic steroid used to treat allergic disorders like colitis, psoriasis and arthritis. The other is the immune system-suppressing drug cyclosporine used for rheumatoid arthritis and psoriasis.

Celiac disease affects between 1 percent and 2 percent of the population worldwide. Apart from a life-long gluten-free diet, no other medical treatment is available.

Activation of T cells leads to the onset of autoimmune disorders. A specific cell receptor, OX40, activates the T cells and GBR 830 blocks its action.

GBR 830 is a first in this class of drugs, Micheal Buschle, president, biologics, and chief scientific officer, of Glenmark Pharmaceuticals Ltd., told BioWorld Today.

"This makes it difficult to assess the value of the drug since no benchmarks are available," he said. Clinical trials could eventually help evaluate its market potential.

"We are excited about the progress of GBR 830, the first OX40 antagonist globally to successfully complete phase 1 studies. OX40 is a very well validated target with the potential to treat a wide array of autoimmune diseases. However, discovering antibodies that inhibit OX40 and do not have agonistic properties which would lead to unwanted side effects has been challenging for the industry. Based on our data GBR 830 is the best in class OX40 antagonistic antibody," said Glenn Saldanha, chairman and managing director of Glenmark.

GBR 830 is one of four MAbs in Glenmark's pipeline, with three in active clinical development programs.

The company also has seven molecules in various stages of preclinical and clinical development, including three new chemical entities (NCEs) and four new biological entities.

The other MAbs include GBR 500 (vatelizumab), a potential first-in-class candidate to treat multiple sclerosis and other autoimmune diseases. GBR 500 has been licensed to Sanofi AG and is in phase II trials in the U.S.

The second is GBR 900, which targets a specific receptor TrkA receptor for chronic pain management and is currently in phase I trials. TrkA receptors or tropomyosin receptor kinase receptors are proteins involved in the development of the nervous system. The project is developed under license from Lay Line Genomics SpA, of Trieste, Italy.

"Monoclonal antibodies specific for TrkA represent a first-in-class opportunity for the treatment of chronic pain, which has a high level of unmet medical need," Buschle said.

Glenmark is also moving forward on trials for its first cancer drug. Last week, the company applied to move forward on phase I trials for GBR 1302, a bispecific antibody for HER2-positive cancers.

GBR 1302 is Glenmark's first clinical candidate targeting cancer. It is a bi-specific antibody – an artificial protein that is composed of fragments of two different monoclonal antibodies and consequently binds to two different types of antigen. It is the first clinical candidate to be based on Glenmark's BEAT platform that facilitates the efficient development and manufacturing of antibodies with dual specificities.