Lupin gets DCGI nod for phase II and III clinical trials of herbal psoriasis drug

19 Jul 2007

Mumbai: Lupin Ltd has received approval from the Drugs Controller General of India (DCGI) to conduct a combined phase-IIb and phase III clinical trial for its herbal anti-psoriasis compound LLL-3348 (Desoris).

The botanical drug product LLL-3348 is a once-daily oral formulation for treatment of chronic stable plaque type psoriasis. The approval comes after the company successfully completed an initial phase II clinical trial in which it evaluated the oral drug product in different lower doses. The study was a multicentric, placebo-controlled, randomised, double blind, parallel group study Lupin said in a filing with the Bombay Stock Exchange (BSE).

The results of the study showed that LLL 3348 administered for 16 weeks is effective in the treatment of psoriasis LLL 3348 produced significant reduction in the psoriatic area and severity in patients with moderate to severe stable plaque type psoriasis. Sixty-two per cent of patients responded to the highest dose in comparison with 21 per cent response in the placebo arm. The safety evaluation demonstrated that the drug was very safe and well tolerated, Lupin said in the statement.

"We are delighted with the approval and look forward to taking LLL-3348 through phase III clinical trials now and bring it to the market. This is a very important product for a highly unmet need and we look forward to addressing it effectively and safely," company''s chairman, D B Gupta said in the filing.

Lupin said it intends to immediately begin a combined phase IIb and III clinical trials with higher doses in close to 10 centers across the country. The total market for psoriasis drugs is estimated to be more than $2 billion. The company also has three other new chemical entities in various stages of clinical trials, the statement added.