mometasone furoate oral (ESO-101) / EsoCap AG - LARVOL DELTA

EsoCap announces publication of comprehensive Phase II results demonstrating ESO-101’s effectiveness in eosinophilic esophagitis (GlobeNewswire) - P2 | N=43 | ACESO (NCT04849390) | Sponsor: EsoCap AG | "The data demonstrate that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in adults with active eosinophilic esophagitis...The ACESO trial met its primary endpoint with a statistically significant reduction of the peak eosinophil count from baseline in histology samples. In the ESO-101 group, the mean reduction was 49.1 ± 88.4 eosinophils/hpf (p=0.0318). In addition, while none of the patients from the placebo group achieved histological remission, 48% and 44% of patients achieved <15 and <6 eosinophils/hpf, respectively, when treated with ESO-101 (p=0.0028 and p=0.0035, respectively)."

P2 data • Eosinophilic Esophagitis

A NOVEL DELIVERY-SYSTEM FOR TOPICAL EOSINOPHILIC ESOPHAGITIS TREATMENT WITH MOMETASONE FUROATE: RESULTS OF THE PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACESO-TRIAL (UEGW 2024) - P2 | "ESO-101 resulted in statistically significant histologic and endoscopic improvements compared with placebo, even with the 4-week treatment duration. ESO-101 was well tolerated. The ACESO study underscores the promise of topical drug delivery to the esophagus using the ESO-101 drug delivery system and provides a robust foundation for future ESO-101 development for EoE therapy."

Clinical • P2 data • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

EsoCap reports positive topline results from ACESO Phase II trial investigating ESO-101 in eosinophilic esophagitis (GlobeNewswire) - P2 | N=43 | NCT04849390 | Sponsor: EsoCap AG | "EsoCap AG...announced today that the ACESO Phase II study comparing ESO-101 to placebo for the treatment of eosinophilic esophagitis has met its primary endpoint by significantly reducing the peak eosinophil count in the histological assessment of esophageal biopsies....The study also showed that ESO-101 demonstrated a highly favorable safety and tolerability profile. 7.1 % (n=2) of patients who received ESO-101 treatment and 26.7 % (n=4) in the placebo group reported mild to moderate adverse events related to the investigational product; no drug related serious adverse events were reported....'Following the successful results of this Phase II study, we now plan to initiate a Phase III program in eosinophilic esophagitis,'...The detailed results from the ACESO study, including secondary endpoint data, will be submitted for presentation at a future scientific conference."

P2 data • Eosinophilic Esophagitis

A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: EsoCap AG | Active, not recruiting ➔ Completed

Trial completion • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: EsoCap AG | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Oct 2023 | Trial primary completion date: Dec 2021 ➔ Oct 2023

Enrollment closed • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

EsoCap completes patient recruitment in ACESO Phase II trial in eosinophilic esophagitis (GlobeNewswire) - "Topline results from ACESO study expected in late 2023....EsoCap AG...reports the completion of patient recruitment in the Phase II ACESO trial. The randomized, placebo-controlled, double-blind study is evaluating the efficacy, tolerability and safety of ESO-101 in 43 adult patients with active eosinophilic esophagitis (EoE) in five European countries....The objectives of the ACESO Phase II trial are to evaluate the efficacy of ESO-101 based on histological response and clinical symptoms."

Enrollment closed • P2 data • Eosinophilic Esophagitis

A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - P2; N=42; Recruiting; Sponsor: EsoCap AG; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - P2; N=42; Not yet recruiting; Sponsor: EsoCap AG

New P2 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology