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news.BTG has initiated multicentre phase IIa study of Pleneva (formerly BGC20-0134), an orally administered compound under development as a potential treatment for multiple sclerosis (MS). Pleneva is designed to restore the balance between pro-inflammatory and anti-inflammatory cytokines in patients with MS.
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The study conducted in 166 patients with the relapsing-remitting (RRMS) form of the disease, comprises an initial 24 week double-blind, placebo-controlled dosing period followed by a 24 week open-label extension.
Reportedly, the primary endpoint of the study is a reduction in the number of new T1 gadolinium enhanced lesions on MRI at weeks 12, 16, 20 and 24, when compared to placebo. A number of MRI and clinical secondary endpoints will further evaluate the safety and efficacy of the drug candidate.
The company said that Pleneva has completed a phase I pharmacodynamic multiple ascending dose study in healthy volunteers, which demonstrated that it was very well tolerated at all doses.
Louise Makin, CEO of BTG, said: “We are pleased to initiate the first study of Pleneva in MS patients. As a novel, oral compound designed to rebalance the levels of pro- and anti-inflammatory cytokines implicated in MS, Pleneva offers the potential of a new treatment option for this chronic, often debilitating condition.”