Inclusion of the first patient in Abivax's Phase 2b (ABX464-103) clinical trial for the treatment of hemorrhagic rectocolitis
The main evaluation criterion is the reduction of Mayo's score to 8 weeks. Secondary endpoints will include clinical remission, improvement by endoscopy and measurement of the fecal biomarker ""calprotectin"". The first results of the induction phase are expected around the end of 2020.
"The main evaluation criterion is the reduction of Mayo's score to 8 weeks. Secondary endpoints will include clinical remission, improvement by endoscopy and measurement of the fecal biomarker ""calprotectin"". The first results of the induction phase are expected around the end of 2020.
""Given the good safety profile of ABX464, as well as the magnitude and duration of its therapeutic efficacy observed in the Phase 2a proof-of-concept study in patients refractory to available treatments, including anti-TNF monoclonal antibodies, we are pleased to enter the next phase of clinical development of this promising drug candidate. This Phase 2b study aims to confirm the long-term efficacy of the anti-inflammatory response of the new mechanism of action of ABX464 in a significantly larger patient population, and to define the optimal dose for future Phase 3 trials. We aim to develop and commercialize ABX464 as an oral treatment with high tolerance and efficacy to meet the needs of the many patients suffering from hemorrhagic rectocolitis who currently have very few therapeutic alternatives,"" said Professor Hartmut J. Ehrlich, General Manager of Abivax."
