DCGI grants permission for India's first siRNA drug trial

Biocon Ltd and Quark Pharmaceuticals Inc, the US-based company focusing on discovery and development of novel RNA interference (RNAi) based therapeutics, has enrolled 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.
 
Drug Controller General of India (DCGI) has granted permission to Biocon and Quark Pharmaceuticals to proceed with the study, the first ever clinical trial of a siRNA 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. 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/II 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.”
 
Bioon and Quark Pharma had entered into a licencing and collaboration agreement in 2013 to co-develop, manufacture and commercialise QPI-1007 in India and other key markets.
 
Dr Daniel Zurr, chairman and CEO, Quark, added, “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 characterised by the death of retinal ganglion cells.”