First siRNA drug trial approved by DCG(I) in India for rare eye disease
Biocon and Quark Pharmaceuticals announced the randomisation of the first patient in India in the pivotal global Phase II/III study of QPI-1007, a novel siRNA (small interfering RNA) drug candidate for ocular neuroprotection. Both the companies have received approval from the Drug Controller General (India) DCG(I) to proceed with the study, the first ever clinical trial of a siRNA therapy in India.
The QRK207 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. 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.
Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon said, “Biocon is committed to develop innovative therapies that address unmet medical needs and the initiation of the Phase II/III study investigating QPI-1007 in NAION in India is an important step towards this goal. India has a significant NAION patient population and we are pleased to be 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.”
“siRNA therapeutics is a new class of breakthrough medicines, with the potential to revolutionise drug development and offer therapeutic precision and widespread applicability and we are delighted to initiate QRK207 in India in this multi-national study to seek a treatment for NAION, a debilitating condition,” stated Dr Daniel Zurr, Chairman and Chief Executive Officer, Quark. “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.”
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.