DCGI approves trials for Biocon, Quark new eye drug
The Dollar Business Bureau
India’s leading Biopharmaceutical firm Biocon Ltd on Thursday said that the Drug Controller General of India (DCGI) has given approval to it and its partner Israel-based Quark Pharmaceuticals Inc to go on with the clinical trials on human subjects for their new drug candidate, 'QPI-1007', which is aimed to treat ocular neuroprotection.
Both the companies also informed the randomisation of first patient in the country in the Phase II/III global study of the latest drug candidate, Biocon said in a statement.
Randomisation is referred to as providing subjects to treatment groups to check selection and accidental bias.
“Biocon and Quark Pharmaceuticals have got the approval from DCGI to go on with the study, the first ever clinical trial of a small interfering RNA (siRNA) therapy in the country,” the company said.
The study is aimed to know the effect of QPI-1007 on eye’s visual function in patients having severe non-arteritic ischemic optic neuropathy (NAION), a rare eye disorder with an unmet need worldwide, it added.
"This is part of Phase II/III global study, conducted by Quark Pharmaceuticals in association with 'Neuro-Ophthalmology Research Disease Investigator Consortium' (NORDIC) and is already registering in the US and several other countries," the statement said.
Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, said, “India has lots of NAION patients and we are glad to be the first bio-pharmaceutical firm to offer siRNA-based therapy in the country. Thousands of patients are will be benefitted, who have either no access to treatment or can’t afford it.”
Daniel Zurr, Chairman and CEO, Quark said that in India it is part of a multi-national study to find a cure for NAION, a debilitating condition.
"QPI-1007 signifies a novel therapeutic approach to treat NAION and future strategy is to make it for extra optic neuropathies, such as glaucoma, which are similar to NAION and characterised by the death of retinal ganglion cells," Zurr said.
In 2013, Biocon Ltd and Quark Pharmaceuticals Inc had signed a licensing and collaboration agreement to co-create, manufacture and market the QPI-1007 in India and other major markets.