Lupin has received approval for conducting phase II clinical trials of its Investigational New Drug candidate, the LLL-3348 (Desoris) from the Drug Controller General of India (DCGI).
Desoris is proposed for the treatment of moderate to severe chronic stable plaque-type psoriasis. Desoris is a 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.
About the commencement of clinical trials of the drug, Lupin Chairman DB Gupta said that there is an imperative need of effective and safe drugs to be made available in the global pharmaceutical market for psoriasis and the company is very excited that the regulatory authorities found its data promising enough to give the permission for further trials.
The candidate has been developed conforming to guidelines laid down by the US FDA for botanicals as well as DCGI guidelines on new drug development. The project is being developed in collaboration with the Centre for Scientific and Industrial Research (CSIR).
The most common form of psoriasis is plaque-psoriasis which is a chronic, immune-mediated disease. 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 patients.
Currently, there are several treatment modalities available for psoriasis including phototherapy and systemic therapies. But most of these are associated with significant cutaneous and systemic adverse effects. The side effect profile of existing drug therapies itself leads to marked reduction in patient's compliance.
The approval comes on Lupin's successful completion of the therapeutic evaluation and safety profiling of Desoris in a phase I single and multiple dose study in healthy volunteers.
