Lupin Ltd has received approval from the Drugs Controller General India (DCGI) to conduct a combined phase-IIb/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, randomized, double blind, parallel group study.

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 Index (PASI score) in patients with moderate to severe stable plaque type psoriasis. 62 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.

Commenting on the approval, Lupin chairman, Dr D B Gupta stated, "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". The company intends to immediately begin a combined phase IIb / III clinical trial with higher doses in close to 10 centers across the nation. The total market for Psoriasis is estimated to be more than US$ 2 Billion. The company also has three other New Chemical Entities in various stages of Clinical trials.