The Hindu Business Line : Lupin gets DCGI nod for skin drug clinical trials

LUPIN Ltd said on Thursday that it has received clearance from the Drug Controller-General of India (DCGI) to commence phase I clinical trial for its investigational new drug (IND) candidate, LLL-3348 (Desoris), indicated for the treatment of a chronic skin condition called psoriasis.

The global market for this indication is estimated over $3 billion, the company said in a communiqué on Thursday.

Psoriasis is recognised by its peculiar clinical symptoms characterised by red patches covered with white scales resulting in itchy flaky skin. It ranges from a few spots to large areas all over body. Although psoriasis manifests as a skin disorder, it is believed to be a disease of impaired or defective cell mediated immunity, the note said.

Desoris is a herbal aqueous extract that acts through a mechanism that effectively modulates the cellular function leading to a marked psoriatic lesion improvement without any toxic effect. Lupin has developed this product in the form of capsules.

Lupin has already completed the therapeutic evaluation and safety profiling of the herbal extract and will start the Phase I clinical trials shortly. Based on animal data, Desoris has been found to be efficacious and safe, besides being applicable once a day.

This is Lupin's second IND based on herbal research that has been approved. Prior to this, Lupin's IND for the treatment of migraine was approved by the DCGI in December 2003.

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