drugset / Press release

XyloCor Therapeutics Presents Phase 2 Data Highlighting Safety and Efficacy of XC001 at the European Society of Cardiology (ESC) Congress 2023 Wayne, PA, August 25, 2023 — XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the European Society of Cardiology (ESC) Congress 2023. During the ESC Congress poster session, Dr. Thomas Povsic, Principal Investigator of the EXACT trial, presented the primary six‑month outcome data from the recently completed EXACT trial, which demonstrated that treatment with XC001 resulted in improvements across all key efficacy endpoints. The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.

2023-08-25 · XyloCor Therapeutics, Inc. · original xylocor.com ↗

• Thirty-two patients included (3 from final dosing cohort Ph 1, 29 Ph 2) • Mean/median ages of 64/64, 34% female) were enrolled at 13 sites between March 2021 and July 2022. Median anti- anginal use was 3, 75% had prior revascularization with CABG and 88% with PCI. • Fifty-five serious adverse events (SAEs) were observed in 21 patients (66%). None were attributed to study drug. Twenty- one SAEs in 14 patients were related to the surgical procedure, all of which were expected. One non-CV death occurred in month 3 following respiratory infection (Covid) deemed unrelated to surgery or study drug. • Compared to baseline: • ∆ total exercise time 85.5 seconds (95% CI 31.3-139.7) at 6-months • total myocardial ischemic deficit in the treated region on PET decreased by 14.4% (95% CI, 3.01–25.73) • Angina frequency and nitroglycerin use measured during a two-week diary decreased by 6.6 episodes (95% CI, 3.5–9.7) and 4.1 doses (95% CI, 1.3–6.9), respectively. • Canadian Cardiovascular Society angina grade decreased from 3.1 to 1.8, mean difference 1.3 classes (95% CI, 1.0–1.6) • Seattle Angina Questionnaire Frequency score improved from 41.3 to 67.4, mean difference of 26.1 (95% CI, 16.3–35.9). ANGIOGENIC GENE THERAPY FOR REFRACTORY ANGINA: RESULTS OF THE EPICARDIAL DELIVERY OF XC001 GENE THERAPY FOR REFRACTORY ANGINA CORONARY TREATMENT (EXACT) PHASE 2 TRIAL Thomas J. Povsic, MD, PhD1; Kenta Nakamura MD2; Timothy D. Henry MD3; Jay H. Traverse MD4; R. D. Anderson MD,5; F. Bakaeen MD6; David A. Latter MD7; E. Magnus Ohman MD1; Mark W. Peterson B8; Dawn Byrnes8; Carl J. Pepine MD9; Ronald G. Crystal MD10; Todd K Rosengart MD11; Nahush A. Mokadam MD12; Howard C. Dittrich MD8 1Duke Clinical Research Institute, Department of Medicine, Duke University, Durham, NC; 2University of Washington, Department of Medicine, Seattle, WA; 3The Christ Hospital, The Carl and Edith Lindner Center of Research and Education, Cincinnati, OH; 4Abbott Northwestern Hospital, Minneapolis Heart Institute Foundation , Minneapolis, MN; 5University of Florida, Heart and Vascular Center, Gainesville, FL; 6Cleveland Clinic Foundation, Department of Thoracic and Cardiovascular Surgery, Cleveland, OH; 7University of Toronto, Department of Cardiovascular Surgery, St. Michael's Hospital, Toronto, Canada 8Xylocor Therapeutics, Malvern, PA; 9University of Florida, Department of Cardiovascular Medicine, Gainesville, FL; 10Weill Cornell Medical College, Department of Genetic Medicine, New York, NY; 11Baylor College of Medicine, Department of Surgery, Houston, TX; 12Ohio State University Wexner Medical Center, Department of Cardiac Surgery, Columbus, OH Conclusions • Refractory or "no option" angina (RA) is a debilitating condition with increasing global prevalence. • Exogenous transduction of vascular endothelial growth factor (VEGF) induces angiogenesis and improves perfusion of ischemic myocardium in preclinical studies. • XC001 (AdVEGFXC1) is a novel adenoviral-5 vector expressing the three major isoforms of VEGF (-121, - 165, -189) in ratios shown to enhance potency and improve safety by increasing expression of heparin binding isoforms. • EXACT (NCT04125732) is a single-arm, multicenter, open-label, phase 2 trial to explore the safety, tolerability, and preliminary efficacy of trans- epicardial delivery of XC001 to improve exercise capacity and ischemic burden in RA patients. Patients: • Stable CCS class II-IV angina • No recent ACS/stroke • Maximally tolerated medical therapy • Anginal limited 90s < ETT < 540s (modified Bruce) • Ischemia on stress PET • Lack revascularization options. Treatment: • XC001 (1x1011 viral particles) injected IM via surgical transthoracic epicardial access in 15 0.1 ml injections Background and Purpose Methods VEGF gene therapy with XC001 administered via minimally invasive transepicardial delivery appears: • Generally well tolerated • No IP related SAEs • SAEs related to surgical procedure all expected and resolved • Improvements in objective and subjective measures including total exercise time, myocardial perfusion, angina frequency and quality of life support a clinically meaningful biologic effect. This therapy warrants study in larger randomized studies. Results

The release as fetched from its publisher. xylocor.com ↗