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.
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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.”
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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.
