Bangalore-based biotech Biocon and RNAi firm Quark Pharmaceuticals said the first patient has received a randomized dose in a clinical trial for ocular neuroprotection siRNA (small interfering RNA) candidate QPI-1007--a first in the country.
The Drug Controller General of India approved a pivotal Phase II/III clinical trial earlier this year to determine the impact on visual function in subjects with acute non-arteritic ischemic optic neuropathy (NAION).
The NAION study with QPI-1007 is being conducted at approximately 66 hospitals in the U.S., Europe, Israel, India and China, Quark said in March. Quark, headquartered in Freemont, CA, partnered with Biocon in India through a 2013 licensing and collaboration pact to manufacture and commercialize QPI-1007 in India and elsewhere.
"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," Biocon managing director and chairwoman Kiran Mazumdar-Shaw said in a statement.
"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."
Quark also has a joint venture there with Suzhou Ribo Life Science called Kunshan RiboQuark Pharmaceutical Technology that was launched two years ago and is in work on QPI-1007 and QPI-1002 for prevention and amelioration of the severity of Delayed Graft Function (DGF) in kidney transplant patients.
Kunshan RiboQuark Pharma holds China rights for QPI-1007.
- here's the release
U.S. biotech Quark's siRNA trials include China, India legs