epeleuton (DS102) / Afimmune - LARVOL DELTA

Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Afimmune | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Mar 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Afimmune | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • VCAM1

Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Afimmune | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • VCAM1

TRIAGE: Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes (clinicaltrials.gov) - P2b | N=233 | Terminated | Sponsor: Afimmune | Completed ➔ Terminated; Trial prematurely terminated on 03 May 2022 due to the results from an interim analysis indicating a lack of efficacy in the study population.

Trial termination • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Afimmune

New P2 trial • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Cardiometabolic risk in young adults with Down syndrome. (PubMed, Am J Med Genet A) - "The group with DS had higher NonHDL-C (mean DS 131.9 mg/dL; NHANES 126.1 p < 0.001), lower HDL-C (DS 47.5 mg/dL; NHANES 52.2 p < 0.001), higher LDL-C (DS 109.3 mg/dL; NHANES 105.4 p < 0.001), higher triglycerides (DS 102.9 mg/dL; NHANES 86.9 p < 0.001), but lower fasting glucose (DS 85.8 mg/dL; NHANES 95.2 p < 0.0001), lower HOMA-IR (DS 2.17; NHANES 2.24 p = 0.0006), lower systolic (DS 109.7 mmHg; NHANES 114.6 p < 0.0001) and lower diastolic (DS 60.9 mmHg; NHANES 67.8 p < 0.0001) blood pressures. There was relationship of higher HDL-C, triglycerides, glucose, systolic, and diastolic blood pressure with increasing BMI in the NHANES cohort which was dampened in the group with DS. These results indicate that more information is needed to guide clinicians in screening for CMR in individuals with DS."

Journal • Developmental Disorders • Dyslipidemia • Genetic Disorders • Metabolic Disorders

Periviscerokinin (Cap; CAPA) receptor silencing in females of Rhipicephalus microplus reduces survival, weight and reproductive output. (PubMed, Parasit Vectors) - "CAP/PVKs appear to be associated with the regulation of female feeding, reproduction and survival. Since the Rhimi-CAPR loss of function was detrimental to females, the discovery of antagonistic molecules of the CAP/PVK signaling system should cause similar effects. Our results point to this signaling system as a promising target for tick control."

Journal

TRIAGE: TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients (clinicaltrials.gov) - P2b | N=233 | Completed | Sponsor: Afimmune | Recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ May 2022 | Trial primary completion date: Aug 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis (clinicaltrials.gov) - P2 | N=9 | Terminated | Sponsor: Afimmune | N=120 ➔ 9 | Suspended ➔ Terminated; Company Decision

Enrollment change • Trial termination • Hepatology • Inflammation

Levothyroxine Variations by Process Analytical Technology. (PubMed, Contact Context) - "Intra-lot and inter-lot variability in the spectra of levothyroxine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Two vials of 12 vials sampled from Athenex lot AFN102 appeared 10.1 and 9.1 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 108 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material."

Journal

TRIAGE: TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients (clinicaltrials.gov) - P2b; N=240; Recruiting; Sponsor: Afimmune; Trial completion date: Dec 2021 ➔ Sep 2022; Trial primary completion date: Oct 2021 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis (clinicaltrials.gov) - P2; N=120; Suspended; Sponsor: Afimmune; Trial completion date: Feb 2020 ➔ Feb 2022; Not yet recruiting ➔ Suspended

Clinical • Trial completion date • Trial suspension • Hepatology

TRIAGE: TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients (clinicaltrials.gov) - P2b; N=240; Recruiting; Sponsor: Afimmune; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers. (PubMed, J Am Heart Assoc) - P2a | "Background Epeleuton is 15-hydroxy eicosapentaenoic acid ethyl ester, a second-generation synthetic n-3 fatty acid derivative of eicosapentaenoic acid...Further trials are planned. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02941549."

Journal • Addiction (Opioid and Alcohol) • Cardiovascular • Diabetes • Dyslipidemia • Hepatology • Hypertriglyceridemia • Immunology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

TRIAGE: TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients (clinicaltrials.gov) - P2b; N=240; Not yet recruiting; Sponsor: Afimmune

Clinical • New P2b trial • Cardiovascular • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2a; N=49; Completed; Sponsor: Afimmune; Recruiting ➔ Completed

Clinical • Trial completion

Safety And Efficacy Study Of Orally Administered DS102 In Patients With NAFLD (clinicaltrials.gov) - P2a; N=96; Completed; Sponsor: Afimmune; Recruiting ➔ Completed; N=69 ➔ 96

Enrollment change • Trial completion

A Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis. Efficacité et tolérance du DS102 administré par voie orale chez des patients atteints d’hépatite alcoolique aiguë sévère (clinicaltrialsregister.eu) - P2; N=126; Ongoing; Sponsor: Afimmune

Clinical • New P2 trial