Biocon, Quark get DCGI nod for trials of new eye disease drug
New Delhi : Bio-pharmaceutical firm Biocon said the Drug Controller General of India (DCGI) has given nod to it and partner Quark Pharmaceuticals to proceed with clinical trials on human subjects for a new drug candidate, 'QPI 1007' aimed for ocular neuro-protection.
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.
Randomisation is the allocation of subjects to treatment groups to prevent selection and accidental bias.
The company further said, "Biocon and its partner, Quark Pharmaceuticals, have received approval from the Drug Controller General of India (DCGI) 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), which is a rare ocular disorder with an unmet need globally, it added.
"This is part of a global Phase II/III study run by Quark in collaboration with 'Neuro-Ophthalmology Research Disease Investigator Consortium' (NORDIC) and is already enrolling in the US and a number of other countries," the statement said.
Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "India has a significant NAION patient population and we are pleased to be the first bio-pharma 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."
Quark Chairman and CEO Daniel Zurr said the study in India is part of a multi-national study to seek a treatment for NAION, a debilitating condition.
"QPI-1007 represents a novel therapeutic strategy for treating NAION and future plans are to develop it for additional optic neuropathies, including glaucoma, which, similar to NAION, are characterized by the death of retinal ganglion cells," Zurr said.
Biocon and Quark Pharma had entered into a licensing and collaboration agreement in 2013 to co-develop, manufacture and commercialize QPI-1007 in India and other key markets.