US-based biopharmaceutical company Ventyx Biosciences has reported positive data from a Phase II clinical trial of VTX002 for the treatment of active ulcerative colitis (UC).
The placebo-controlled, double-blind trial assessed the safety and efficacy of two oral doses of the S1P1 receptor modulator, VTX002.
Patients with moderate-to-severely active UC received 30mg and 60mg of VTX002 orally once a day for 13 weeks.
The proportion of patients achieving clinical remission at week 13, as defined by the modified Mayo Clinic Score, was the trial’s primary endpoint.
Its secondary endpoints included histologic, symptomatic and endoscopic outcome measures.
The primary endpoint of clinical remission was achieved in 28% of patients who received the 60mg dosage of VTX002 and 24% of patients given the 30mg dose, against 11% of patients treated with placebo.
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Ventyx Biosciences founder and CEO Raju Mohan said: “We are very excited to share the positive Phase II results for VTX002, which we believe establish VTX002 as a potential best-in-disease oral therapy for UC based on its combined efficacy and safety profile.”
No instances of atrioventricular block or bradycardia, treatment-related serious adverse events or cases of macular oedema were observed in the trial.
VTX002 was found to be well-tolerated in both dose cohorts, with a greater mean reduction in absolute lymphocyte count observed in patients treated with the 60mg dose than those in the 30mg dose group.
Ventyx Biosciences president and chief medical officer William Sandborn said: “The positive Phase II data for VTX002 establish a highly attractive profile for an oral agent in moderate-to-severely active UC, with the 60mg dose achieving a compelling clinical remission rate, an unprecedented rate of complete endoscopic remission, and an excellent safety and tolerability profile.
“I would like to thank all of the patients and investigators for their participation in this trial.”