Lupin receives IND approval from DCGI for Desoris LLL-3348

By Our Corporate Bureau | 28 Nov 2005

Lupin Ltd has received the Drug Controller General of India''s (DGCI) approval for conducting phase II clinical trials of its investigation new drug candidate LLL-3348 (Desoris). Desoris is proposed for the treatment of moderate to severe chronic stable plaque-type psoriasis.

The most common form of psoriasis is plaque-psoriasis which is a chronic, immune-mediated disease, which can cause severe physical discomfort and have a significant impact on a persons quality of life. The disease manifests itself as lesions that are classically well circumscribed, circular, red papules or plaques with a grey or silvery-white, dry scale. Psoriasis can have a significant negative impact on the physical, emotional, and psychosocial well-being of affected patients.

Several modes of treatment are currently available for psoriasis including phototherapy and systemic therapies, but most of these are associated with significant cutaneous (relating to or affecting the skin) and systematic adverse effects. The side effect of existing drugs itself often leads to reduction in patient''s compliance.

Speaking on the DGCI''s approval the nod to go ahead for further clinical trials, Dr D B Gupta, chairman, Lupin Ltd, said, "There is an imperative need of effective and safe drugs to be made available in the global pharmaceutical market for psoriasis and we are very excited that the regulatory authorities found out data promising enough to give us permission for further trials."

The approval comes in the wake of Lupin''s successful completion of the therapeutic evaluation and safety profiling of Desoris in phase I single and multiple dose study in healthy volunteers. Desoris will now be evaluated for efficacy in patients in a phase II clinical trial by the company across 10 sites.

According to Lupin, Desoris is herbal aqueous extract of a single plant that has a novel mechanism of action and effectively modulates the cellular function leading to marked psoriatic lesion improvement without any toxic effects. The drug candidates have been developed conforming to guidelines laid down by the US FDA for botanicals as well as DCGI guidelines on new drug development.

The Desoris project is being developed in collaboration with the CSIR''S ''new millennium Indian technology leadership initiative (NMITLI), a unique private-public partnership, under the aegis of the ministry of science and technology.