The Drug Controller General of India (DCGI) has given its nod to biopharmaceutical firm Biocon and its Israeli partner Quark Pharmaceuticals to proceed with human clinical trials for a new drug candidate, 'QPI-1007' targeting orphan eye disease.
Orphan eye disease is a condition that affects fewer than 200,000 people nationwide.
‘India's first siRNA therapy will benefit thousands of patients with acute non-arteritic ischemic optic neuropathy who either have no access to treatment or cannot afford it.’
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.
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.
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 randomization of the first patient in India in the global Phase II/III study of the new drug candidate, the company said in a statement.