IMR-261 / Enliven Therapeutics - LARVOL DELTA

Nitro-oleic acid (CXA-10) prevents cerebral aneurysm formation via endothelial PPARδ activation (AHA 2025) - "CXA-10 demonstrated a dose-dependent effect against CA formation, likely through the endothelial-protective effect of PPARδ receptor activation. Further research is warranted to provide insights into its mechanism of action and optimize clinical applications."

Cardiovascular • Hematological Disorders • Inflammation • Subarachnoid Hemorrhage • Vascular Neurology • ELANE

ALMA: Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Jan 2029 ➔ Jan 2030 | Trial primary completion date: Nov 2028 ➔ Nov 2029

Trial completion date • Trial primary completion date • Asthma • Genetic Disorders • Immunology • Obesity • Pulmonary Disease • Respiratory Diseases

ALMA: Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Colorado, Denver | Active, not recruiting ➔ Recruiting

Enrollment open • Asthma • Genetic Disorders • Immunology • Obesity • Pulmonary Disease • Respiratory Diseases

ALMA: Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: University of Colorado, Denver | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Jan 2029 | Trial primary completion date: Aug 2024 ➔ Nov 2028

Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Genetic Disorders • Immunology • Obesity • Pulmonary Disease • Respiratory Diseases

IMR-261, A NOVEL, ORAL NRF2 ACTIVATOR, REDUCES IRON OVERLOAD IN AN EXPERIMENTAL MOUSE MODEL BY ACTIVATING BMP6-MEDIATED HEPCIDIN SYNTHESIS (EHA 2022) - "IMR-261 also showed significant reductions in TSAT, ferritin, GDF15 and erythropoietin, which further support its role in iron homeostasis. Induction of hepcidin synthesis via Nrf2 activation is a novel therapeutic approach, and these results support further clinical development of IMR-261 as a treatment for conditions associated with iron dysregulation, including hereditary hemochromatosis."

Preclinical • Beta-Thalassemia • Genetic Disorders • Hematological Disorders • Hepatology • Sickle Cell Disease • GDF15 • SMAD7

IMR-261, a Novel Oral Nrf2 Activator, Induces Fetal Hemoglobin in Human Erythroblasts, Reduces VOCs, and Ameliorates Ineffective Erythropoiesis in Experimental Mouse Models of Sickle Cell Disease and Beta-Thalassemia (ASH 2021) - "IMR-261 also increased Hb and improved ineffective erythropoiesis in a beta-thalassemia in-vivo model. Together these data suggest that IMR-261 is a promising, novel, oral therapy that warrants clinical testing in SCD and beta-thalassemia."

Preclinical • Beta-Thalassemia • Genetic Disorders • Hematological Disorders • Immunology • Inflammation • Pain • Sickle Cell Disease • CD14 • CD34 • HMOX1 • HSP90AA1 • IL1B • IL6 • NFE2L2 • TFRC • TNFA

Oral CXA-10 in Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=2; Terminated; Sponsor: Gladwin, Mark, MD; N=30 ➔ 2; Trial completion date: Dec 2023 ➔ Dec 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Jun 2023 ➔ Dec 2020; negative study outcome from Complexa's multicenter clinical trial; no safety concerns

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

CXA-10 Study in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=33; Terminated; Sponsor: Complexa, Inc.; N=96 ➔ 33; Trial completion date: Feb 2021 ➔ Aug 2020; Recruiting ➔ Terminated; LOE

Enrollment change • Trial completion date • Trial termination • Hypertension • Pulmonary Arterial Hypertension

PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2; N=69; Terminated; Sponsor: Complexa, Inc.; Trial completion date: Dec 2020 ➔ Aug 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Dec 2020 ➔ Aug 2020; LOE

Clinical • Trial completion date • Trial primary completion date • Trial termination • Hypertension • Pulmonary Arterial Hypertension • MRI

FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2; N=33; Completed; Sponsor: Complexa, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Jul 2020; Trial primary completion date: Dec 2021 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Renal Disease

PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2; N=96; Active, not recruiting; Sponsor: Complexa, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hypertension • Pulmonary Arterial Hypertension • MRI

FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2; N=30; Active, not recruiting; Sponsor: Complexa, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Apr 2021 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Diabetic Nephropathy • Focal Segmental Glomerulosclerosis • Renal Disease

Complexa completes patient enrollment in phase 2 FIRSTx trial evaluating CXA-10 in focal segmental glomerulosclerosis, a rare and severe form of kidney disease (Businesswire) - "Complexa Inc. today announced the completion of patient enrollment in the FIRSTx study, a Phase 2 clinical trial evaluating the safety and efficacy of the company’s lead candidate, CXA-10, to treat primary focal segmental glomerulosclerosis (FSGS)....The results of the initial 90-day dosing treatment phase are expected in the second half of 2020 with an open-label extension continuing into 2021."

Enrollment closed • New trial • P2 data • Focal Segmental Glomerulosclerosis

Study of CXA-10 in healthy volunteers (clinicaltrials.gov) - P1, N=57; Sponsor: Complexa; Recruiting; New P1 trial.

New P1 trial • Acute Kidney Injury • Renal Disease

Oral CXA-10 in Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=30; Active, not recruiting; Sponsor: Gladwin, Mark, MD; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Complexa, Inc.; Trial completion date: Nov 2019 ➔ Apr 2021; Trial primary completion date: Nov 2019 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date

Oral CXA-10 in Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Gladwin, Mark, MD; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Phase 2 Multicenter, Open-Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS): FIRSTx (KIDNEY WEEK 2019) - P2; "Planned statistical analysis includes testing of pooled within-subject changes in proteinuria, as well as comparison of UPC and eGFR in study subjects to historical controls. Additional information can be found at www.FIRSTx-trial.com."

Clinical • P2 data

CXA-10 Study in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Complexa, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open

CXA-10 Study in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=96; Not yet recruiting; Sponsor: Complexa, Inc.

Clinical • New P2 trial

PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Complexa, Inc.; Trial completion date: Aug 2019 ➔ Dec 2020; Trial primary completion date: Aug 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Complexa, Inc.; Trial completion date: Jul 2019 ➔ Nov 2019; Trial primary completion date: Jul 2019 ➔ Nov 2019

Clinical • Trial completion date • Trial primary completion date