Biotechnology company BioTheryX Inc reported on Thursday the receipt of US Food and Drug Administration (FDA) clearance for the investigational new drug application (IND) for BTX-A51 for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

In the third quarter of 2019, the company plans dosing of first patients with relapsed/refractory AML or high-risk MDS.

According to the company, BTX-A51 is a small molecule, oral multi-kinase inhibitor that appears to block a specific leukemic stem cell target (CK1-alpha) as well as super-enhancer targets (CDK7/CDK9) preventing transcription of key oncogenic genes.

Additionally, the company's pre-clinical assets include a library of novel small molecule, cereblon-binding targeted protein degraders, Protein Homeostatic Modulators (PHM). These IP-protected compounds are biologically active against a number of high value therapeutic targets in oncology, inflammation and other diseases.