Product
Pleneva™ (formerly BGC20-0134)
Indication
Multiple sclerosis
Phase
Phase IIa
Description
Pleneva™ is an orally administered compund designed to restore the balance between pro-inflammatory (e.g. tumour necrosis factor-α TNFα) and anti-inflammatory cytokines (e.g. transforming growth factor-β1, TGFβ1) in patients with multiple sclerosis (MS).
Further Information
In a small single-centre, double-blind, placebo-controlled clinical pilot study, an experimental Pleneva™ prototype provided clinical benefits to patients with RRMS, including decreases in both relapse rate and EDSS scores*, with additional benefits seen on pain and cognitive endpoints.
In preclinical models of MS, Pleneva™ showed three-fold higher potency than the prototype compound. Hence Pleneva™ has potential to show greater therapeutic benefit and potential for disease modification than the prototype.
This compound has completed a Phase I with a combined single and repeat, rising dose study in healthy male and female subjects.
According to the World Health Organisation, multiple sclerosis affects around 2.5 million people worldwide. It is one of the most common neurological disorders and cause of disability of young adults, especially in Europe and North America. Most patients are diagnosed with the relapsing-remitting form of the disease (RRMS), however, secondary and primary progressive MS (SPMS, PPMS) represent diseases with high unmet medical need. Although there are treatments licensed for the treatment of RRMS they have limited effectiveness and are without effect in SPMS and PPMS.
The cause of MS is unknown, but there is strong evidence for the involvement of autoimmune mechanisms in the development of the disease. Dysregulation of key cytokines occurs, leading to neuronal damage and subsequently the slow onset of symptoms and disability.
Dosing of patients has commenced in a European multicentre Phase IIa study of Pleneva™. If clinical proof of principle is demonstrated in the Phase IIa study, development partners will be sought to conduct Phase IIb and subsequent studies.
Please contact our Business Development Team for more information.
*EDSS stands for Expanded Disability Status Scale and is an objective way of measuring neurological symptoms where 0 is normal and 10 is death due to MS.
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