Ulcerative Colitis Treatment Prepares for Phase 3 Study

A clinical-stage biotechnology company announced the progression of its development program for its lead drug candidate, ABX464, into phase 3 preparation for the treatment of moderate-to-severe ulcerative colitis (UC).

According to Abivax’s press statement, ABX464 has already shown a good safety profile in previous trials, these new studies will provide additional data required to support Abivax in seeking recommendations and agreement of the regulatory agencies in Europe and the US Food and Drug Administration(FDA) for the phase 3 development plan in UC, scheduled to be initiated during the second half of 2021.

And, Abivax announced it will complete the induction phase of its ongoing phase 2b trial in UC, its ongoing phase 2b/3 study in COVID-19 patients, as well as the planned pivotal phase 2b/3 study in Crohn’s disease (CD) during 2021.

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, commented: “I am confident that the results of the ulcerative colitis phase 2b and of the complementary phase 1 studies will contribute positively to a fruitful exchange with the regulators and enable us to progress our lead drug candidate smoothly towards phase 3 and market access.”

“As inflammatory bowel diseases, including ulcerative colitis, are also very common in parts of Asia, which have different clinical requirements, the initiation of the clinical testing of ABX464 in Japan is an important step for Abivax and will broaden partnering options.” 

“There is a worldwide high unmet medical need in inflammatory bowel diseases and, despite the promising progress for an effective COVID-19 vaccine, a potent treatment to prevent severe COVID-19 disease remains a global priority.”

“We are putting significant efforts into ABX464 development and potential commercialization, to make ABX464 and its unique properties available to patients in need of novel treatment approaches worldwide.”

Complementing the ongoing clinical and regulatory activities, manufacturing scale-up and process optimization for the development of ABX464 tablets are currently being conducted in order to add to the existing oral capsule a user-friendly tablet form.

At present, the 2021 planned ABX464 production capacities are amounting to 12 million doses.

Paris-based Abivax is a clinical-stage biotechnology company mobilizing the body’s natural immune machinery to treat patients with chronic inflammatory diseases, viral infections, and cancer. 

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