Vedanta Biosciences has dosed the first patient in the Phase II COLLECTiVE202 clinical trial of VE202 to treat ulcerative colitis (UC).
The placebo-controlled, double-blind, randomised study is being carried out at sites in Europe and the US.
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It is enrolling 100 patients aged between 18 and 75 years with mild-to-moderate UC to assess two different regimens.
They will receive either the defined bacterial consortium candidate VE202 or placebo as an add-on to their background therapy.
Safety and endoscopic response are the primary endpoints, while clinical response and remission are the secondary endpoints of the study.
Other secondary endpoints include quality-of-life measures along with additional endoscopic, histologic, colonisation, inflammatory and immune biomarkers.
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By GlobalDataVedanta Biosciences chief medical officer Jeffrey Silber said: “Although new therapies for ulcerative colitis are efficacious for many, they are often accompanied by potential safety concerns, including the risk of infection.
“We are pleased that the FDA has granted Fast Track designation for VE202. We believe this candidate could offer patients with ulcerative colitis an alternative approach to treatment with a favourable safety profile.
“We look forward to advancing this programme as we work to address an important unmet medical need.”
VE202 is a live biotherapeutic product that consists of 16 bacteria strains that help in reversing gut microbiota abnormalities, inducing immune tolerance in the gut and strengthening the epithelial barrier.
In a Phase I study conducted in healthy volunteers, strains of VE202 were colonised following pretreatment with vancomycin in both a dose and duration-dependent fashion.
VE202 also converted primary bile acids into immunomodulating secondary bile acids that offer protection against intestinal inflammation in comparison to placebo.
No treatment-related serious adverse effects were observed and VE202 was found to be well tolerated.
