North Carolina, USA-based 9 Meters Biopharma (Nasdaq: NMTR) saw its shares rise nearly 22% to $0.25, after it announced positive final results from the Phase II study of vurolenatide and the outcome from its End-of-Phase II meeting with the US Food and Drug Administration (FDA).
Vurolenatide, previously known as NB 1001, is a proprietary long-acting glucagon like peptide1 (GLP-1) receptor agonist in development for adults with short bowel syndrome (SBS). Based on the outcome from the meeting and the Phase II data, 9 Meters intends to finalize the Phase III protocol in collaboration with the FDA during the fourth quarter. Clinical plans and activities are currently underway to facilitate initiation of the study upon protocol finalization.
This seems to be an encouraging result for the biotech, which earlier this year suffered a setback with what was its lead candidate CedLara (lazarotide), which failed to demonstrate a significant impact on coeliac disease symptoms in a Phase III trial, as a result of which 9 Meters has switched its attention to vurolenatide.
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