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Biocon receives approval from Drug Controller General of India for the first ever clinical trial of a siRNA therapy



Biocon – one of the largest emerging global biopharmaceutical enterprise (has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin analog) announced (more here) that the company in partnership with Quark Pharmaceuticals – which majorly is involved in discovery and development of novel RNA interference (RNAi) – have received approval from the Drug Controller General of India (DCGI) to proceed with the study, the first ever clinical trial of a siRNA therapy in India.

As per the statement released by the company “The QRK207 study will determine the effect of QPI-1007 (read below on what is 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.”

Commenting on this approval, here is what the company’s Chairperson & Managing Director Kiran Mazumdar-Shaw 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.

Commenting on this approval, here is Dr. Daniel Zurr, Chairman and CEO of Quark said:

siRNA therapeutics is a new class of breakthrough medicines, with the potential to revolutionize 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.
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.
It takes strong partnerships to translate novel science into commercial therapies to help people and we are extremely pleased to have partnered with Biocon, an innovative company best positioned to lead the siRNA based drug class development in India.

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.

About QPI-1007
QPI-1007 is a double stranded RNA molecule chemically modified by Quark’s proprietary technology. The drug is designed to temporarily inhibit the expression of caspase 2 and thereby block the apoptotic death of retinal ganglion cells. QPI-1007 is being developed as a neuroprotectant for the treatment of NAION and in the future other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells (RGCs). QPI-1007 has been evaluated in a human, dose escalation, Phase I/IIa Study (Protocol QRK007), delivered by single intravitreal injection to Optic Nerve Atrophy patients with low visual acuity and thereafter in acute NAION patients. This study was conducted at 22 sites in the US and 6 sites in Israel. This study showed that a single intravitreal injection of QPI-1007 was well tolerated in subjects with long-standing low vision or acute NAION. The drug has also demonstrated protective activity compared to historical data. QPI-1007 was also studied in a Phase IIa clinical trial in acute angle closure glaucoma patients in the United States, Vietnam and Singapore.

About the Study
This study is a pivotal Phase II/III, randomized, double masked, sham-controlled trial of QPI-1007 delivered by multi-dose intravitreal injections to subjects with acute non-arteritic anterior ischemic optic neuropathy (NAION) to compare the safety and efficacy of two doses of QPI-1007 along with the sham group. This multi-national, multi-centric trial is being conducted across 95 hospitals in several countries including India, US, Israel, Germany, Australia, Italy and China. Approximately 465 patients will be enrolled globally. The treatment for each patient will be 12 months.



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