getagozumab (GMA301) / Gmax Biopharm - LARVOL DELTA

Next-generation therapeutics and renaissance of legacy drugs targeting the endothelin system. (PubMed, Can J Physiol Pharmacol) - "Endothelin-1 (ET-1) was discovered in 1988, followed by identification of ETA and ETB receptors in 1990, enabling rapid development of the first endothelin receptor antagonists (bosentan, ambrisentan, and macitentan) for pulmonary arterial hypertension, a condition marked by elevated ET-1. Nearly a decade later, a new therapeutic wave began with the ETB agonist sovateltide (2021) for cerebral ischemic stroke, demonstrating the benefits of ETB activation...Clazosentan (ETA) for cerebral vasospasm and aprocitentan (ETA/ETB) for resistant hypertension extended endothelin-targeted therapy into more common diseases. In kidney disease, sparsentan (AT1/ETA) and atrasentan (ETA) have both been approved for IgA nephropathy, with atrasentan succeeding after earlier failed trials...This review outlines approaches for identifying legacy endothelin compounds suitable for new indications, using zibotentan, now combined with dapagliflozin to reduce fluid retention as an example. Kidney..."

Journal • Review • Cardiovascular • Glomerulonephritis • Hypertension • IgA Nephropathy • Ischemic stroke • Nephrology • Pulmonary Arterial Hypertension • Pulmonary Disease • Renal Disease • Respiratory Diseases • EDN1

Emerging biologics for the treatment of pulmonary arterial hypertension. (PubMed, J Drug Target) - "Here, we have discussed sotatercept, a TGF-β ligand trap, which is reported to reverse vascular remodeling and reduce PVR with an improved 6-minute walk distance (6-MWDT). We also elaborated on other biologics including BMP9 ligand and anti-gremlin1 antibody, anti-OPG antibody, and getagozumab monoclonal antibody and cell-based therapies. Overall, recent literature suggests that biologics hold excellent promise as a safe and effective alternative to currently used PAH therapeutics."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • TGFB1

A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Gmax Biopharm LLC.; N=36 ➔ 48; Trial completion date: Jun 2022 ➔ Jun 2023; Trial primary completion date: Sep 2021 ➔ Oct 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Gmax Biopharm Australia Pty Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers (clinicaltrials.gov) - P1; N=16; Active, not recruiting; Sponsor: Gmax Biopharm Australia Pty Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hypertension • Pulmonary Arterial Hypertension

A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Gmax Biopharm Australia Pty Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hypertension • Pulmonary Arterial Hypertension

A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Gmax Biopharm Australia Pty Ltd.

Clinical • New P1 trial • Hypertension • Pulmonary Arterial Hypertension

A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Gmax Biopharm LLC.

Clinical • New P1 trial • Hypertension • Pulmonary Arterial Hypertension