Therapy Areas: Inflammatory Diseases
Imago BioSciences passes US FDA's approval of IND Application of IMG-7289 for Myeloid Malignancies
2 February 2018 -

Pharmaceutical company Imago BioSciences said on Thursday that it has successfully filed its Investigational New Drug (IND) application for IMG-7289 with the US Food and Drug Administration (FDA) for myelofibrosis (MF).

Following the US FDA's clearance, the company will proceed with the clinical development of IMG-7289 in the US. The IND supports the ongoing Phase 1/2 clinical trial of IMG-7289 for myelofibrosis (MF).

According to the company, IMG-7289 is a small molecule developed by inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating gene expression in hematopoietic cells. IMG-7289 demonstrated robust in vivo activity as a single agent and in combination across malignancy models.

This Phase 1/2 open-label clinical trial is designed to assess the pharmacodynamics of the company's IMG-7289 in high-risk myelofibrosis patients aged 18 or older. Assessments include measuring changes in spleen volume, patient reported total symptom scores, mutant allele burden, inflammatory cytokines as well as bone marrow fibrosis over the course of the treatment period.

In conjunction, the trial commenced in Australia in 2017 and will add multiple sites in the US in 2018, concluded the company.