MZE829 Well-tolerated with Dose-proportional Pharmacokinetics Supporting Once Daily Dosing
Data Support Advancement of MZE829 into Planned Phase 2 Clinical Trial in Patients with AKD
Data Presented Today at the American Society of Nephrology Kidney Week 2024
SOUTH SAN FRANCISCO, CA, USA I October 25, 2024 I Maze Therapeutics, a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, today announced positive results from the Phase 1 clinical trial of MZE829 in healthy volunteers. MZE829 is an oral, small molecule inhibitor of APOL1 that Maze is advancing as a potential treatment for people living with APOL1 kidney disease (AKD), a subset of chronic kidney disease estimated to affect over one million patients in the United States alone. APOL1 is a protein encoded by the APOL1 gene in humans. Genetic variants of the gene (G1 and G2) are associated with increased risk for a spectrum of progressive kidney diseases in people of West African ancestry. MZE829 was identified through insights generated from Maze’s proprietary, purpose-built platform, Maze Compass™.
The first-in-human Phase 1 randomized, placebo-controlled, single and multiple ascending dose trial was designed to evaluate the safety, pharmacokinetics (PK), food effect, and potential drug interactions of orally administered MZE829 in healthy volunteers and enrolled 111 participants. Results demonstrated that MZE829 was well tolerated at single doses up to 480 mg and multiple doses up to 350 mg, with all treatment-related adverse events reported as mild and no severe or serious adverse events reported. Dose-proportional PK was observed with low variability across doses. The observed half-life of approximately 15 hours supported that MZE829 can be dosed once daily. Evaluation of potential drug interactions demonstrated that MZE829 has the potential to be administered together with standard of care medicines used in patients with AKD, including cyclosporine and tacrolimus.
“We are very pleased with the positive outcome of our Phase 1 trial of MZE829, demonstrating its tolerability and establishing the dosing regimen that we plan to take into our Phase 2 trial in patients with AKD,” said Harold Bernstein, M.D., Ph.D., president, R&D, and chief medical officer of Maze. “Based on its mechanism targeting APOL1, as well as genetics data derived through our Compass platform, we believe that MZE829 has the potential to address a large population of patients with AKD. As such, we intend to enroll patients with a wide array of characteristics into our Phase 2 trial to reflect the full spectrum of AKD patients and determine which patients may benefit from treatment with MZE829.”
The company anticipates that the Phase 2 clinical trial will employ an open-label basket design to include a range of clinical phenotypes and moderate to severe forms of disease as determined by level of proteinuria. The Phase 2 trial will include AKD patients carrying two copies of the high-risk APOL1 alleles (G1 and G2) and evaluate efficacy using uACR reduction across a broad AKD population. The company expects to initiate the Phase 2 trial in the first quarter of 2025.
About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, with a focus on renal, cardiovascular and related metabolic, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. For more information, please visit mazetx.com, or follow us on LinkedIn and X (formerly Twitter).
SOURCE: Maze Therapeutics
Post Views: 2,468
MZE829 Well-tolerated with Dose-proportional Pharmacokinetics Supporting Once Daily Dosing
Data Support Advancement of MZE829 into Planned Phase 2 Clinical Trial in Patients with AKD
Data Presented Today at the American Society of Nephrology Kidney Week 2024
SOUTH SAN FRANCISCO, CA, USA I October 25, 2024 I Maze Therapeutics, a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, today announced positive results from the Phase 1 clinical trial of MZE829 in healthy volunteers. MZE829 is an oral, small molecule inhibitor of APOL1 that Maze is advancing as a potential treatment for people living with APOL1 kidney disease (AKD), a subset of chronic kidney disease estimated to affect over one million patients in the United States alone. APOL1 is a protein encoded by the APOL1 gene in humans. Genetic variants of the gene (G1 and G2) are associated with increased risk for a spectrum of progressive kidney diseases in people of West African ancestry. MZE829 was identified through insights generated from Maze’s proprietary, purpose-built platform, Maze Compass™.
The first-in-human Phase 1 randomized, placebo-controlled, single and multiple ascending dose trial was designed to evaluate the safety, pharmacokinetics (PK), food effect, and potential drug interactions of orally administered MZE829 in healthy volunteers and enrolled 111 participants. Results demonstrated that MZE829 was well tolerated at single doses up to 480 mg and multiple doses up to 350 mg, with all treatment-related adverse events reported as mild and no severe or serious adverse events reported. Dose-proportional PK was observed with low variability across doses. The observed half-life of approximately 15 hours supported that MZE829 can be dosed once daily. Evaluation of potential drug interactions demonstrated that MZE829 has the potential to be administered together with standard of care medicines used in patients with AKD, including cyclosporine and tacrolimus.
“We are very pleased with the positive outcome of our Phase 1 trial of MZE829, demonstrating its tolerability and establishing the dosing regimen that we plan to take into our Phase 2 trial in patients with AKD,” said Harold Bernstein, M.D., Ph.D., president, R&D, and chief medical officer of Maze. “Based on its mechanism targeting APOL1, as well as genetics data derived through our Compass platform, we believe that MZE829 has the potential to address a large population of patients with AKD. As such, we intend to enroll patients with a wide array of characteristics into our Phase 2 trial to reflect the full spectrum of AKD patients and determine which patients may benefit from treatment with MZE829.”
The company anticipates that the Phase 2 clinical trial will employ an open-label basket design to include a range of clinical phenotypes and moderate to severe forms of disease as determined by level of proteinuria. The Phase 2 trial will include AKD patients carrying two copies of the high-risk APOL1 alleles (G1 and G2) and evaluate efficacy using uACR reduction across a broad AKD population. The company expects to initiate the Phase 2 trial in the first quarter of 2025.
About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, with a focus on renal, cardiovascular and related metabolic, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. For more information, please visit mazetx.com, or follow us on LinkedIn and X (formerly Twitter).
SOURCE: Maze Therapeutics
Post Views: 2,468
