isuzinaxib (APX-115) / AptaBio - LARVOL DELTA

PROMISS-DKD: Efficacy and Safety Study of Isuzinaxib in Subjects With DKD (clinicaltrials.gov) - P2 | N=186 | Not yet recruiting | Sponsor: Aptabio Therapeutics, Inc.

New P2 trial • Diabetic Nephropathy • Nephrology • Renal Disease

Targeting NADPH Oxidase with APX-115: Suppression of Platelet Activation and Thrombotic Response. (PubMed, Antioxid Redox Signal) - "00, 000-000. [Figure: see text]."

Journal • Cardiovascular • Hematological Disorders • Thrombosis • PLCG2 • SYK • VAV1

Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Aptabio Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Kidney Injury • Nephrology • Renal Disease • KIM1

A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19. (clinicaltrials.gov) - P2 | N=16 | Terminated | Sponsor: Aptabio Therapeutics, Inc. | N=80 ➔ 16 | Recruiting ➔ Terminated; Enrollment Challenges

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease

Angiotensin II acts through Rac1 to upregulate pendrin: Role of NADPH oxidase. (PubMed, Am J Physiol Renal Physiol) - "However, NADPH oxidase inhibition with APX 115 reduced apical pendrin abundance in vivo in ang II-treated mice...Rac1 may stimulate pendrin, at least partly, through NADPH oxidase. This increase in pendrin abundance contributes to the increment in blood pressure and kidney superoxide content seen in angiotensin II-treated mice."

Journal • Cardiovascular • Hypertension • RAC1 • SLC26A4

Pan-Nox inhibitor treatment improves renal function in aging murine diabetic kidneys. (PubMed, Kidney Res Clin Pract) - "Furthermore, Klotho expression was significantly decreased in diabetic aging kidneys, and APX-115 restored Klotho level. Our results provide evidence that pan-Nox inhibition may improve systemic insulin resistance and decrease oxidative stress, inflammation, and fibrosis in aging diabetic status and may have potential protective effects on aging diabetic kidney."

Journal • Preclinical • Chronic Kidney Disease • Diabetic Nephropathy • Fibrosis • Immunology • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • KL • NOX4 • TGFB1

A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19. (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Aptabio Therapeutics, Inc. | Trial completion date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Feb 2023 ➔ Sep 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

Effect of Isuzinaxib, Pan NOX Inhibitor in Patients With Type 2 Diabetes and CKD in a Randomized, Double Blind, Placebo Controlled Phase 2 Trial (KIDNEY WEEK 2022) - P2 | "Funding Commercial Support Background Isuzinaxib (APX-115), a novel inhibitor of pan NOX; oxidative stress modulator was investigated a kidney outcome in patients with type 2 diabetes (T2DM) and chronic kidney disease (CKD) compared with Placebo...Conclusion Isuzinaxib resulted in anti-albuminuric effect and was safe and well tolerable in patients with T2DM and CKD. The results demonstrate first clinical evidence by NADPH oxidase (NOX) inhibitors contributing to oxidative stress in patients with T2DM and CKD."

Clinical • P2 data • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • KIM1

A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19. (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: Aptabio Therapeutics, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: Mar 2022 ➔ Mar 2023; Trial primary completion date: Feb 2022 ➔ Feb 2023

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP • IFNG • IL6

Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy (clinicaltrials.gov) - P2; N=140; Completed; Sponsor: Aptabio Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

[VIRTUAL] APX-115 against diabetic kidney disease: from bench to phase II clinical trial (KSN 2021) - No abstract available

Clinical • P2 data • Diabetic Nephropathy • Nephrology • Renal Disease

A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19. (clinicaltrials.gov) - P2; N=80; Not yet recruiting; Sponsor: Aptabio Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy (clinicaltrials.gov) - P2; N=140; Active, not recruiting; Sponsor: Aptabio Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Aptabio, US FDA approved COVID-19 treatment phase 2 clinical IND [Google translation] (Pharm News) - "Aptabio announced on the 24th that it has received approval for the phase 2 clinical trial IND from the US FDA for APX-115, a treatment for COVID-19....According to the company, this clinical trial is a Phase 2, double-blind, placebo-controlled, efficacy and safety study of APX-115 in inpatients with confirmed mild to moderate COVID 19 in 12 hospitals in the U.S. It is administered in a 14-day dosing system for 80 people in the country....The company said, 'It includes patients within 14 days of being diagnosed with COVID-19, and a wider range of patients than antiviral and antibody treatments approved for emergency use were selected.'"

IND • Infectious Disease • Novel Coronavirus Disease

Will Aptabio's new drug substance lead to Big Pharma and L/O? [Google translation] (thebell) - "The fastest progress is the diabetic nephropathy treatment (APX-115) using the Knox platform. Currently, Phase 2 is in progress in Europe, and the interim results of Phase 2 will be confirmed during the first quarter of this year."

P2 data • Type 2 Diabetes Mellitus

Aptabio, is there a cure for Corona 19? 'APX-115' Submitted IND for Phase 2 clinical trial to the US FDA [Google translation] (Pax Economic TV) - "Aptabio...has submitted a phase 2 clinical trial plan (IND) of the US Food and Drug Administration (FDA) for 'APX-115', a candidate for COVID-19 treatment....Company plans to begin testing on 80 patients at 12 hospitals in the U.S. when the phase 2 clinical trial plan submitted to the US FDA is approved. Unlike the test on a small number of patients, 'APX-115' revealed that it will test a wider range of patients, including patients within 14 days after diagnosis....It announced that it plans to develop the Corona 19 treatment as an oral treatment in the form of a capsule..."

IND • New P2 trial • Infectious Disease • Novel Coronavirus Disease

APX-115, a pan-NADPH oxidase inhibitor, protects development of diabetic nephropathy in podocyte specific NOX5 transgenic mice. (PubMed, Free Radic Biol Med) - "Moreover, APX-115 inhibited the expression of inflammation-related proteins such as TRAF6. Collectively, these data suggest that APX-115 might be a promising therapeutic agent for the treatment of DN because of its pan-NOX inhibitory activity, including its NOX5 inhibitory activity, and also owing to its anti-inflammatory effects."

Journal • Preclinical • Diabetes • Diabetic Nephropathy • Immunology • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy (clinicaltrials.gov) - P2; N=140; Recruiting; Sponsor: Aptabio Therapeutics, Inc.

Clinical • New P2 trial • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Renal Disease • Type 2 Diabetes Mellitus