Advanced NanoTherapies Provides Updates on Early Studies of SirPlux Duo DCB

November 4, 2024—Advanced NanoTherapies (ANT), a member of the T45 Labs portfolio that is developing a nanoparticle technology-based platform for drug delivery, recently announced findings from ADVANCE-DCB, its first-in-human (FIH) trial evaluating the next-generation SirPlux Duo drug-coated balloon (DCB) outside the United States.

The company also announced plans to proceed toward initiating its DYNAMIC DUO I United States early feasibility study (EFS) to evaluate the safety and performance of the SirPlux Duo DCB in de novo coronary lesions. The commencement of enrollment in the ADVANCE-DCB FIH trial was announced August 2023.

According to the company, the ADVANCE-DCB FIH trial reported 4% symptomatic target lesion failure, with an average late lumen loss of 0.24 (± 0.30) at 6-month follow-up. Longer-term follow-up continues. ANT plans to submit the data for presentation at the EuroPCR 2025 conference that will be held May 20-23 in Paris, France.

ANT stated that the DYNAMIC DUO I EFS is a prospective, multicenter, nonrandomized study that will enroll and treat patients experiencing symptomatic stable angina, unstable angina, or non–ST‐segment elevation myocardial infarction with de novo coronary lesions with reference vessel diameters of 2 to 4 mm.

The results from DYNAMIC DUO I will inform the company on how to advance its clinical programs to broader commercialization plans in the United States and global markets, advised ANT.

The SirPlux Duo DCB, which delivers a dual-drug therapy of sirolimus and paclitaxel, is intended for vessel patency and restenosis prevention, noted ANT.

“The innovative drug delivery platform of the SirPlux Duo DCB is poised to redefine how coronary disease is treated,” commented Bernardo Cortese, MD, in the company’s press release. “By combining two proven drugs with the novel nanoparticle technology, SirPlux Duo DCB aims to minimize drug flaking, deliver sustained drug therapy at therapeutic levels, and get the best characteristics of the two drugs, theoretically making it a strong front-line device alternative to current DCBs or drug-eluting stents.”

Dr. Cortese is Director, Interventional Coronary Center, University Hospitals and Professor of Medicine, Case Western Reserve University in Cleveland, Ohio.