Orchestra BioMed (Nasdaq:OBIO) today announced the first patient enrollments in a study of its Virtue Sirolimus AngioInfusion Balloon (SAB).
The FDA investigational device exemption (IDE) trial compares the Virtue SAB to the Boston Scientific Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated balloon (DCB) for coronary indication, picking up approval in March.
New Hope, Pennsylvania-based Orchestra BioMed won FDA IDE in April. IDE enabled the company to initiate an updated design of its planned Virtue SAB in the Treatment of Coronary ISR Trial. The company also continues to advance its atrioventricular interval modulation (AVIM) therapy.
Orchestra said the initial cases successfully took place at The Christ Hospital Heart & Vascular Institute in Cincinnati, Ohio, and St. Francis Hospital & Heart Center in Roslyn, New York. The company expects to enroll up to 740 patients across up to 75 centers in the U.S. It expects to complete enrollment in mid-2027.
Virtue SAB delivers a large liquid dose of a proprietary extended-release sirolimus formulation, called SirolimusEFR. It’s delivered through a non-coated, microporous AngioInfusion balloon that protects the drug in transit. Orchestra says this helps overcome certain limitations of existing DCBs.
SirolimusEFR aims to enable enhanced tissue uptake and extended sirolimus release through the critical healing period. This exceeds previously published target tissue concentrations of proven drug-eluting stents. A pilot study previously demonstrated promising clinical results for treating single-layer coronary in-stent restenosis (ISR).
Orchestra plans to use results from the Virtue trial to support regulatory approval in the U.S.
“We believe the future of arterial disease treatment will be driven by optimized delivery and extended tissue release of therapeutic doses of sirolimus, the proven antiproliferative drug with well-established safety and effectiveness,” said Darren R. Sherman, president and COO of Orchestra BioMed. “Balloon surface-coating drug delivery has challenges and limitations, including dosing constraints, drug-loss that requires rapid device navigation, and the release of large embolic particulates. We designed Virtue SAB and its key enabling technology, our proprietary SirolimusEFR, to overcome these limitations and realize the full potential of arterial drug delivery during angioplasty. With the launch of the Virtue Trial, we’re taking a major step toward realizing our vision of improving patient outcomes.”
