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