9 Meters Biopharma, Inc. announced receipt of a written response from the U.S. Food and Drug Administration (FDA) on the request for a Type B pre-IND (Investigational New Drug) meeting on the planned pre-clinical development of NM-136 for the treatment of obesity. Based on the response, the Company currently plans to submit an IND to the FDA for this indication in the second half of 2023 based on the completion of the preclinical program. An approved IND is a prerequisite for conducting Phase 1 clinical studies of NM-136 in the U.S. Completion of this interaction with the FDA represents an important milestone and provides greater regulatory clarity and direction on the data needed to support an IND submission including input on the nonclinical plans and a proposed design of the Phase 1 study.

NM-136 is a novel humanized monoclonal antibody antagonist targeting glucose-dependent insulinotropic polypeptide (GIP). The Company believes NM-136 is a first-in-class humanized monoclonal antibody specifically targeting and binding GIP in the systemic circulation. GIP plays a critical role in promoting nutrient uptake and storage and has been shown to promote fat accumulation in humans.

Pre-clinical data has demonstrated that anti-GIP monoclonal antibodies can effectively produce weight loss in obese mice without affecting food consumption.