ASP8731 / Astellas - LARVOL DELTA

The BACH1 inhibitor ASP8731 inhibits inflammation and vaso-occlusion and induces fetal hemoglobin in sickle cell disease. (PubMed, Front Med (Lausanne)) - "Townes-SS mice were gavaged once per day for 4 weeks with ASP8731, hydroxyurea (HU) or vehicle. ASP8731 and HU also increased HBG and HBA, but not HBB mRNA in erythroid differentiated CD34+ cells derived from SCD patients. These data indicate that BACH1 may offer a new therapeutic target to treat SCD."

Journal • Genetic Disorders • Hematological Disorders • Inflammation • Sickle Cell Disease • BACH1 • BRIP1 • CD34 • HMOX1 • ICAM1 • RELA • VCAM1

A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults (clinicaltrials.gov) - P1 | N=36 | Terminated | Sponsor: Astellas Pharma Global Development, Inc. | N=160 ➔ 36 | Trial completion date: Mar 2023 ➔ Nov 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2023 ➔ Nov 2022; The study was terminated due to protocol defined stopping criteria being met.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Enrollment open • Trial completion date • Trial primary completion date

ML-0207/ASP8731: A Novel BACH1 Inhibitor That Induces Fetal Hemoglobin in Treatment of Sickle Cell Disease (ASH 2021) - "The increases in F-cells were accompanied by increases in blood A-gamma globin and erythrocytes and decreases in leukocytes. Taken together, these data support BACH1 inhibitors as potential novel and effective treatments for SCD patients."

Genetic Disorders • Hematological Disorders • Immunology • Inflammation • Pain • Reperfusion Injury • Sickle Cell Disease • BACH1 • BRIP1 • CD34 • HMOX1 • ICAM1 • NQO1 • SLC7A11 • TFRC • VCAM1

A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults (clinicaltrials.gov) - P1; N=124; Not yet recruiting; Sponsor: Astellas Pharma Global Development, Inc.

Clinical • New P1 trial