Lupin Limited has received approval for the commencement of phase I clinical trial of its Investigational New Drug candidate LLL-3348 (Desoris) from the Drug Controller General of India (DCGI). Desoris is orally bioavailable and proposed for the treatment of chronic stable plaque type psoriasis.

“Lupin is one of the few companies to get an Investigational New Drug Application (INDA) approval for New Chemical Entities (NCE). The approval is a testimony to Lupin's world-class R&D. It marks a significant step in Lupin's long-term strategy towards becoming an innovation-led transnational pharmaceuticals company,” Lupin chairman Dr. Desh Bandhu Gupta said.

The global market for this indication is estimated over $3 billion.

Psoriasis is a chronic skin condition, which is recognized for its peculiar clinical symptoms characterized by circumscribed 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.

Dr. Sudershan Arora, president-NCE, Lupin Ltd. said, “There is an imperative need of effective and safe drugs to be made available in global pharmaceutical market for this chronic inflammatory skin disorder. In addition, the side effect profile of existing drugs leads to marked reduction in patient’s compliance.”

Desoris is an herbal aqueous extract that acts through a novel mechanism of action 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.