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26 Jul 2015

Biocon’s first time ophthalmology molecule, QPI-1007, entered in clinical trial

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Biocon’s novel drug pipeline which has an ophthalmology molecule, QPI-1007, is entering clinical trial phase. QPI-1007 is for ocular neuroprotection in NAION and acute angle closure glaucoma. So long the company has been engaged in the development of therapies for diabetes, oncology and immunosuppressant space.

In mid-December 2013, the company entered into a licensing and collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeutics with Quark Pharmaceuticals which was researching on QPI-1007.

The collaboration with Quark was to enable Biocon to co-develop, manufacture and commercialize QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets.

In April 2014, the Ophthalmology Times had reported that “Quark Pharmaceuticals one intravitreal injection of QPI-1007 to treat non-arteritic anterior ischemic optic neuropathy (NAION) was safe with no serious adverse events in a phase I trial.

“Quark is the world leader in this technology and our joint development efforts on QPI-1007, targeting ocular neuroprotection aims at providing relief to several patients suffering from serious ophthalmic conditions. This collaboration reinforces our commitment to develop and introduce innovative therapeutics to India to meet the unmet medical needs. We hope to use this technology for developing several other novel therapeutics, said Shaw in an earlier communication.

“We will have access to Quark’s innovative and proprietary siRNA technology platform that can be leveraged for the development of novel therapeutics for various unmet medical needs,” she added.

QPI-1007 completed a phase I/IIa first in human, open label, single-dose, dose escalation, safety, tolerability and pharmacokinetic study conducted at 16 centres in the USA and five centres in Israel.

Glaucoma is a slowly progressing optic neuropathy characterized by the progressive loss of retinal ganglion cells (RGCs) and is the leading cause of blindness worldwide. The nerve damage and visual loss from glaucoma is usually irreversible. Neuroprotection has been proposed as a therapeutic strategy in glaucoma to promote survival of retinal ganglion cells.

In India, it is estimated that glaucoma affects 12 million people accounting for 12.8 per cent of the country’s blindness and by 2020, this is expected to reach 16 million.

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