Drug firm Zydus Cadila on Monday said it has received approval to commence Phase II clinical study of its upcoming product with patients suffering from Cryopyrin-Associated Periodic Syndrome (CAPS) in Australia.
The company has received permission to initiate the Phase II clinical study of its NLRP3 inhibitor 'ZYIL1' in patients with CAPS in Australia.
The clinical trial in Australia will study the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with CAPS, Zydus Cadila said in a statement.
CAPS is a rare life-long auto-inflammatory condition, and is classified under orphan diseases. CAPS patients also experience multiple neurological complications like sensorineural hearing loss, migraine, headache, aseptic meningitis and myalgia.
"The CAPS patient community has very limited treatment options and there is a huge unmet medical need. We are committed to develop novel therapies, and ZYIL1 has potential to treat several autoimmune diseases," Cadila Healthcare Chairman Pankaj R Patel noted.
Cadila Healthcare is the listed entity of the Ahmedabad-based drug maker.
ZYIL1 is a novel oral small molecule NLRP3 inhibitor. It was found to be safe and well-tolerated in Phase I trials.
Earlier in January this year, the Drugs Controller General of India (DCGI) had approved conducting phase III trials of the country's first DNA vaccine candidate against Covid-19 being developed by Zydus Cadila, the Department of Biotechnology had then said.
The vaccine candidate had been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the DBT.
“The nation's first indigenously developed DNA vaccine candidate against Covid-19, ZyCoV-D, by M/s Zydus Cadila, has been approved by Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials," the DBT had said.
Zydus Cadila completed Phase-I/II clinical trials of this DNA vaccine candidate in more than 1,000 participants and "interim data indicated that the vaccine is safe and immunogenic when three doses were administered intradermally", the DBT had added.
