Advanced NanoTherapies (ANT) has reported positive outcomes from its first-in-human (FIH) trial of the SirPlux Duo Drug-Coated Balloon (DCB).  

The company is preparing to launch an early feasibility study in the US to further evaluate the performance and safety of this treatment for de novo coronary lesions. 

SirPlux Duo DCB is a new therapy that simultaneously delivers sirolimus and paclitaxel, two drugs known for their efficacy in inhibiting cell growth.  

This dual-drug therapy aims to enhance vessel patency and prevent restenosis. 

ANT co-founder and CEO Marwan Berrada-Sounni said: “We are thrilled to take this next step in further validating the clinical performance of SirPlux Duo DCB, a novel technology licensed from the Cleveland Clinic.” 

“Moving forward with our DYNAMIC DUO I EFS aligns with our vision of advancing nanotechnology-driven solutions that combine the power of sirolimus and paclitaxel to offer a safe and prolonged therapy without leaving a permanent implant behind.” 

ANT's nanoparticle drug encapsulation platform facilitates safe and sustained long-term bioavailability of both drugs within the tissue, without the need for a stent.  

The upcoming DYNAMIC DUO I early feasibility study (EFS) is a prospective, multi-centre, non-randomised trial targeting patients with symptomatic stable angina, unstable angina, or NSTEMI who have de novo coronary lesions with reference vessel diameters between two and four millimetres. 

The results of this study are expected to guide ANT in expanding its clinical programmes towards broader commercialisation in both the US and international markets.  

In August 2023, the company secured a $4m Series A extension from a strategic medical device company.  

Additionally, ANT successfully treated its first group of participants in the ADVANCE-DCB FIH trial, showcasing initial short-term safety data for the SirPlux Duo DCB in treating de novo coronary artery disease (CAD).