 "Biocon begins clinical trials for drug to treat rare eye disorder")
India's drug controller cleared the phase-II and -III trials to be done locally on patients with acute non-arteritic ischmetic optic neuropathy (NAION), a condition that causes vision loss due to reduced blood suply to the optic nerve. India has a large number of patients who go blind due to this condition.
Biocon said this is the first time the Drug Controller General of India (DCGI) has approved siRNA therapy, a targeted and safer category of drugs, for clinical trials in India.
"India has a significant NAION patient population and we are pleased to be the first biopharma company in the country to provide a siRNA-based therapy that is likely to benefit thousands of patients who either have no access to treatment or cannot afford it," Biocon chairperson and managing director Kiran Mazumdar-Shaw said in the statement.
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. Around 465 patiennts in US, Israel, Australia, Italy and China will be enrolled in the trials to be completed over 12 months.
"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," said Dr. Daniel Zurr, chairman and chief executive officer of Quark.
Both firms also plan to develop this drug for other eye disorders that is similar to NAION, they said.
Biocon's stock closed Rs 3.15 or 0.44 per cent to Rs 718.35 on the Bombay Stock Exchange on Thursday.
