NatureWise’s new drug, NBM-BMX, received USFDA approval on January 4th, 2023 to proceed in Phase Ib/II clinical trials in newly diagnosed GBM. Glioblastoma multiforme is one of the most aggressive, invasive, and deadly malignancies. More than 60% of newly diagnosed GBM patients do not respond to standard treatment. Our studies demonstrated that NBM-BMX is a new therapeutic approach with the potential for addressing this need for safer, more effective treatment options for GBM.

In 2018, in a letter approving the initiation of phase 1 clinical trials, the USFDA requested NatureWise schedule an end of phase 1 (EOP1) meeting with the FDA when NatureWise completed the phase 1 clinical program. In September 2021, NatureWise completed a phase 1 clinical trial in the USA, submitted the trial results to the USFDA along with a draft of the phase 2 study protocol for glioblastoma multiforme, and requested an EOP1 meeting. In December 2021, in the response letter for the EOP1 meeting, the USFDA commented on the trial results and suggested changes for the phase 2 clinical study [...]

NatureWise’s new chemical entity, NBM-MBX, received US Food and Drug Administration (FDA) approval on July 24th to proceed Phase I clinical trial. NBM-MBX is an isoform-selective histone deacetylase 8 (HDAC 8) inhibitor. The high specificity produces less side effects than those of non-selective HDAC inhibitors. […]