FDA Clears Pre-IND Meeting For RTX-NP As Oddifact And Mabion Advance ITP Program

(RTTNews) - Mabion S.A. (MAB) and Oddifact SAS, announced that the U.S. FDA has granted a Type B pre-IND meeting for RTX-NP (MabionCD20), a jointly developed rituximab product.

The product is being advanced for adult patients with persistent or chronic primary immune thrombocytopenia (ITP) who have had an insufficient response, relapse or dependence following first-line therapy.

The FDA opened a Pre-IND file under Oddifact's name and classified the request as a Type B meeting with the Division of Nonmalignant Hematology, providing the companies an opportunity to align with the Agency on key development and regulatory questions for RTX-NP.

ITP is a rare autoimmune disorder characterized by abnormally low platelet counts. Although rituximab has demonstrated clinical activity in ITP, it has not received formal FDA approval for this indication.

RTX-NP has received FDA Orphan Drug Designation and is being developed with the goal of establishing a regulatory-backed treatment option for ITP patients who require additional treatment following first-line therapy.

MabionCD20 completed its Phase 3 clinical trials in January and February 2023, while RTX-NP has received FDA Orphan Drug Designation.

The companies said the FDA meeting represents an important milestone toward finalizing the development strategy and potential Biologics License Application (BLA) submission for RTX-NP.

The collaboration combines Mabion's expertise in monoclonal antibody development and manufacturing with Oddifact's experience in rare diseases and indication repurposing, with the companies aiming to advance RTX-NP toward clinical development and potential commercialization in the U.S.

MAB.WA has traded between $6.70 and $10.00 over the past year. Currently, MAB.WA is trading at $8.04, up 4.12%.