Abivax soars in Paris as new data on the drug Obefazimod provide reassurance
Positive indications for patients with refractory ulcerative colitis. The application for marketing authorisation is expected to be submitted in the fourth quarter
(Il Sole 24 Ore Radiocor) - Abivax soars on the Paris Stock Exchange, thanks to reassuring safety data on Obefazimod, a drug for ulcerative colitis. Shares in the French biopharmaceutical company rose by 34% to over €111, by far the biggest gainer on the SBF 120 index and the Stoxx Europe 600. Abivax has released the results of Part 2 of a Phase III trial, which is the final stage of clinical trials prior to a potential application for marketing authorisation.
The first part, published in early June, had raised serious concerns about the drug’s safety and caused the share price to plummet by 43.6 per cent, as it had been reported that a number of cancer cases had occurred at the highest dose of 50 milligrams. In the new publication, Abivax presented highly positive data for patients with refractory ulcerative colitis (UC) treated with the drug.
Obefazimod provided “a significant clinical benefit” in a population of patients with highly refractory UC, with 37.2% of patients who had not responded to induction therapy achieving clinical remission and 34.5% who achieved endoscopic remission at week 44 following continued treatment with 50 mg of Obefazimod. Furthermore, increasing the dose of Obefazimod from 25 to 50 mg restored clinical remission in 45.5% of patients who had relapsed during the first part of the study’s maintenance phase, "supporting a practical strategy of dose escalation to regain and maintain disease control over time".
Abivax also highlighted that the additional safety data from this Part 2 expand the safety database and “provide an important context for interpreting the oncological safety data reported in the Part 1 analysis of the maintenance study”. As stated in the press release, “as part of the integrated Phase 2 and Phase 3 programme for ulcerative colitis (1,704 patient-years of exposure), the exposure-adjusted incidence rates for neoplasms, excluding non-melanoma skin cancer (NMSC), were 0.35 and 0.64 events per 100 patient-years (‘PY’), whilst for NMSC they were 0.59 and 0.64 events per 100 PY respectively in the cohorts receiving the combined active drugs (50 mg + 25 mg) and 50 mg, all consistent with the expected baseline rates for ulcerative colitis”.
Analysts at Stifel comment that the safety data provided are “reassuring”, with the incidence of malignant tumours within expected limits, and they also highlight the potential for further efficacy in patients with treatment-refractory ulcerative colitis. The published data therefore provide important clinical validation of the efficacy of Obefazimod in a population with highly refractory ulcerative colitis, particularly in patients who did not achieve a clinical response following the initial 8-week induction period.
