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Lupin receives DCGI approval to conduct phase II trials for Psoriasis NCE
Our Bureau, Mumbai | Wednesday, July 26, 2006, 08:00 Hrs  [IST]

Lupin Ltd has received approval from Drugs Controller General (India) (DCGI) to conduct phase - II clinical trials for its Psoriasis pure compound LL-42 18 (Desoside-P).

The DCC has found clinical phase I data of LL-4218 (Desoside-P) satisfactory and has granted the company permission to continue phase II clinical trials on the molecule. The company intends to begin clinical trials at 5-6 centres immediately.

LL-4218 is a pure molecule and is obtained from a plant source. It is orally bio-available and is intended for the treatment of chronic stable plaque type psoriasis. This molecule's novel mechanism of action leads to marked psoriatic lesion improvement without any toxic effects. There is an imperative need of effective and safe drugs to be made available in global pharmaceutical market as also the side effect profile of existing drugs leads to marked reduction in patient's compliance. The total market for Psoriasis is estimated to be more than $ 2bn.

Commenting on the approval, Dr Desh Bandhu Gupta chairman, stated, "We are delighted that our phase I data has been found to be satisfactory for us to proceed with further clinical trials. We are very excited with taking the molecule forward and look forward to meeting this otherwise unmet market need".

The company also has three other New Chemical Entities in various stages of clinical trials.

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