GEN-3026 / Gencia, Takeda - LARVOL DELTA

HU6 REDUCES LIVER FAT IN SUBJECTS WITH HIGH BMI NAFLD: TOP-LINE RESULTS FROM A PHASE 2a TRIAL (AASLD 2022) - "HU6 dosing was associated with significant improvements across primary and secondary endpoints important for NAFLD/NASH. The safety and tolerability of HU6 combined with the ability to reduce hepatic and whole-body adiposity and the enhanced treatment effect in subjects with and without elevated HbA1c suggest the potential to improve patient outcomes by improving NASH parameters and potentially reduce the progression to end stage liver disease."

Clinical • P2a data • Fibrosis • Hepatology • Immunology • Inflammation • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity

Complications of left ventricular assist devices causing high urgency status on waiting list: impact on outcome after heart transplantation. (PubMed, ESC Heart Fail) - "Left ventricular assist device therapy can impair the outcome after HTx. However, the occurrence of LVAD complications may not impact on outcome after HTx. Thus, we cannot support the prioritization or discrimination of HTx candidates according to distinct mechanical circulatory support-associated complications. Future allocation strategies have to respect that device-related complications may define urgency but do not impact on the outcome after HTx."

Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Thrombosis • Transplantation

Multiple Ascending Dose Study of HU6 in High BMI Volunteers (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Rivus Pharmaceuticals, Inc.

Clinical • New P1 trial • Hepatology • Non-alcoholic Steatohepatitis

Sex Differences in Time-Series Changes in Pseudo-R Values Regarding Hyperuricemia in Relation to the Kidney Prognosis. (PubMed, J Pers Med) - "The pseudo-R values for HU6 in women showed an increasing pattern, with a 6Y-End Change of 11.4%/year. Thus, it may be clinically meaningful to consider sex differences in the time-series pseudo-R values regarding HU and kidney outcomes."

Journal • Chronic Kidney Disease • Nephrology • Renal Disease

Global plasma protein profiling reveals DCM characteristic protein signatures. (PubMed, J Proteomics) - "After plasma depletion using a MARS Hu-6 column, global proteome profiling was performed using a LTQ-Orbitrap Velos mass spectrometer...PON1 levels were also determined by an ELISA. These data highlight PON1 as a potential marker for differentiating DCM patients not only from patients with normal LVEF, but also from heart failure patients with preserved ejection fraction."

Biomarker • Clinical • Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Inflammation • Metabolic Disorders

Ascending Dose Study of HU6 in Healthy Volunteers (clinicaltrials.gov) - P1; N=74; Recruiting; Sponsor: Rivus Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatology • Non-alcoholic Steatohepatitis

Ascending Dose Study of HU6 in Healthy Volunteers (clinicaltrials.gov) - P1; N=103; Not yet recruiting; Sponsor: Rivus Pharmaceuticals, Inc.

Clinical • New P1 trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis