Lupin gets DCGI nod for phase-II trials of Psoriasis NCE

Mumbai, July 26 (UNI) Pharma major Lupin has received approval from Drugs Controller General, India (DCGI) to conduct phase-II clinical trials of its Psoriasis pure compound LL-42 18 (Desoside-P).

The DCGI 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, which the company intends to begin at 5-6 centres immediately, Lupin said in a release issued here.

LL-4218 is a pure molecule and is obtained from a plant source. It is orally bioavailable 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 US dollar 2 billion.

On the approval, company's Chairman Dr Desh Bandhu Gupta said, ''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.'' It also has three other new chemical entities in various stages of clinical trials.

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