Biomedical company Orchestra BioMed has secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the Virtue ISR-US study of Virtue Sirolimus AngioInfusion Balloon (SAB).

Virtue SAB is a patented drug/device combination product candidate in the development phase to treat certain artery diseases.

The US-based Orchestra BioMed intends to evaluate the safety and efficacy of Virtue SAB in the treatment of patients with coronary in-stent restenosis (ISR).

The IDE approval was based on positive three-year follow-up results from the pilot SABRE study.

SABRE is a European multi-centre, prospective, independent core lab-adjudicated clinical trial in coronary ISR patients.

The Virtue ISR-US study will compare Virtue SAB to Plain Old Balloon Angioplasty (POBA) in the treatment of single-layer coronary ISR.

It is a randomised, prospective, double-blind, multi-centre, controlled trial that will randomly assign about 300 people in a ratio of 2:1 to Virtue SAB or POBA.

The primary efficacy and safety endpoint of the study is target lesion failure (TLF) at 12 months.

Additionally, the biomedical company intends to enrol about 100 people with double-layer coronary ISR for treatment with Virtue SAB in a non-randomised arm.

Orchestra BioMed president, COO and founder Darren Sherman said: “We believe that Virtue SAB has the potential to address a significant unmet clinical need and improve outcomes for a patient population with suboptimal treatment options.

“In a field currently dominated by paclitaxel-coated balloons, Virtue SAB is the only device that provides protected delivery of extended release sirolimus, the class of drugs used on all currently marketed coronary drug-eluting stents, to the treated artery during angioplasty without the need for a coating or a permanent implant.

“This IDE approval and forthcoming pivotal study reflect our commitment to accelerating innovation through our differentiated, partnership-enabled business model.”

The firm will commence enrolment following the completion of regular clinical trial initiation operations. The conditional approval also requires Orchestra BioMed to provide the FDA with more information.

Virtue SAB is designed to deliver SirolimusEFR to the artery during balloon angioplasty without using a balloon coating or a permanent implant.

SirolimusEFR is said to be a proprietary, investigational, extended release formulation of sirolimus.

Orchestra BioMed also has a partnership with Japan-based Terumo on the global development and commercialisation of Virtue SAB in coronary and peripheral vascular indications.