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Biopharmaceutical firm Biocon and its partner Quark Pharmaceuticals have received approval from the Drug Controller General of India (DCGI) to proceed with clinical trials on humans for a new drug that is aimed at treating nerve damages in the eyes.
This trial will be for the global Phase II or III study of QPI-1007, a novel siRNA (small interfering RNA) drug candidate used to treat ocular neuro protection, medical terminology for nerve damages in the eyes, which results in blindness.
siRNA-based therapy involves suppressing specific disease-related genes, an area which the scientific community considers as a breakthrough in biology in this decade.
Further, 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 eye disorder that is caused due to loss of blood flow to the optic nerve. This is part of a global Phase II and III studies run by Quark with Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC).
Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw said: “This is an unmet medical need and the initiation of the Phase II or III study investigating QPI-1007 in NAION in India is an important step towards this goal. Biocon and Quark Pharma had entered into an agreement, in 2013, to co-develop, manufacture and commercialise QPI-1007 in India and other key markets”.
To put it in perspective, India has a significant NAION patient population and a siRNA-based therapy can benefit thousands of patients who either have no access to treatment or cannot afford it, she added.
Industry watchers pointed out that there have been many clinical trials that have been conducted to study more than a dozen therapies but none have convincingly improved the visual outcome in patients with NAION.
“Some studies have investigated the use of corticosteroids which have resulted in a mild improvement, but these studies did not use rigorous scientific methods and it remains unknown if steroids are actually helpful,” said an eye doctor from a leading hospital chain.
Biocon shares closed at ₹718, marginally up by 0.44 per cent.
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