Thomas Povsic, MD, PhD, on EXACT Clinical Trial: Investigating Gene Therapy for Refractory Angina

“Everything we saw in phase 1 was very encouraging and suggested to us that we had a dose that might be efficacious. While there was some risk with surgical delivery, the adverse events that were observed were all expected and related to the actual surgery. We didn't see anything safety wise that was related to the therapy itself. So that was very encouraging that we could go forward with the highest dose as well as the fact that we saw a dose response and improvement in exercise times, angina frequency, CCS and angina class, was all very reassuring. We look forward to presenting the phase 2 results.”

XC001 (encoberminogene rezmadenovec; XyloCor Therapeutics) gene therapy administered via epicardial delivery was well-tolerated and has demonstrated clinical benefit in patients with refractory angina, including improvements in total exercise duration and reductions in ischemic burden and ischemic symptoms, according to updated data from the phase 1/2 EXACT clinical trial (NCT04125732).

CGTLive spoke with principal investigator Thoams Povsic, MD, PhD, professor of medicine, cardiology, Duke University School of Medicine, to learn more about XC001 and the EXACT trial. He discussed the trial design and noted that the surgical delivery of the gene therapy was well-tolerated with expected adverse events. He noted that updated results from the phase 2 portion of the trial will be presented at a scientific meeting in August. He shared that dose-dependent responses were seen in treated patients and that initial results from the trial are encouraging.

REFERENCE

XyloCor Therapeutics Reports Sustained Results in 12‑Month Extension of Phase 2 EXACT Clinical Trial of XC001 Novel Gene Therapy for Refractory Angina. News release. XlyoCor Therapeutics. July 18, 2023. http://www.xylocor.com/news.html