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Biocon and its Israeli partner Quark Pharmaceuticals said that the Drug Controller General of India (DCGI) has given its nod to it and to proceed with human clinical trials for a new drug candidate, ‘QPI-1007’ targeting orphan eye disease. Both the companies have also received approval to proceed with the study, the first ever clinical trial of a siRNA (small interfering RNA) therapy in India.
The study will determine the effect of QPI-1007 on visual function in subjects with acute non-arteritic ischemic optic neuropathy (NAION), a rare ocular disorder with an unmet need globally.
Biocon CMD Kiran Mazumdar-Shaw said, “India has a significant NAION patient population. We are the first biopharma company in the country to provide an siRNA-based therapy that is likely to benefit thousands of patients who either have no access to treatment or cannot afford it.”
Biocon and Quark Pharmaceuticals also announced the randomisation of the first patient in India in the global Phase II/III study of the new drug candidate, the company said in a statement.
