Product
BGC20-0134
Indication
Multiple sclerosis
Phase
Phase I
Description
BGC20-0134 is an orally administered structured lipid 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 BGC20-0134 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, BGC20-0134 showed three-fold higher potency than the prototype compound. Hence BGC20-0134 has potential to show greater therapeutic benefit and potential for disease modification than the prototype.
This compound has entered Phase I with a combined single and repeat, rising dose study in healthy male and female subjects. It is scheduled to be progressed to a proof-of-concept Phase IIa study in MS patients.
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.
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