Orchestra BioMed, a biomedical innovation company, announced results from its MODERATO II double-blind, randomised study of BackBeat Cardiac Neuromodulation Therapy (CNT). In a press release, the company states that it demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in hypertensive patients also indicated for a pacemaker.
The results, which were presented at a late-breaking session at the Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2019; 24-29 September, San Francisco, USA) by Karl-Heinz Kuck (Lans Medicum, Hamburg, Germany), showed the study met its primary efficacy endpoint, with patients randomised to BackBeat CNT experiencing an 11.1 mmHg (p<0.001) reduction in mean 24-hour ambulatory systolic blood pressure (ASBP) at six months follow-up, resulting in a significant difference of 8.1mmHg compared to control patients who were managed only with antihypertensive medications (p=0.01). The study also met its primary safety endpoint with no statistical difference in rate of major cardiac adverse events (MACE) between the two groups at six months follow-up.
All patients enrolled in the MODERATO II study, a European prospective, multicentre, double-blind, randomised study of BackBeat CNT versus control in 47 patients with persistent hypertension (ASBP ≥130mmHg and office systolic blood pressure (OSBP) ≥140 mmHg) despite one or more antihypertensive medications and a pacemaker indication, were implanted with Orchestra BioMed’s Moderato System, an implantable pulse generator that delivers BackBeat CNT, as well as standard rhythm management functions, that recently received CE mark approval. Following a 30-day run-in period, during which patients received only standard pacing along with antihypertensive medications, patients who met follow-up screening criteria for daytime ASBP, were randomised to BackBeat CNT or control groups. Prior to randomisation, mean ASBP for both groups were 136.3mmHg with patients, on average, treated with more than three prescribed antihypertensive drugs. After six months, mean ASBP was reduced by 11.1mmHg (p<0.001) in the BackBeat CNT group as compared to a reduction of 3.1mmHg in the control group (p=0.17). The treatment group saw an overall response rate of 85%, with approximately 54% of the BackBeat CNT-treated patients experiencing ASBP reduction at six months of >10mmHg, an amount associated with a clinically meaningful reduction in risk of heart attack and stroke. The BackBeat CNT group also experienced significantly greater reduction, 12.4mmHg, in OSBP over the control group (p=0.02). There were no MACE events in the BackBeat CNT group and three events in two patients in the control group. Additionally, there were no notable differences in echo parameters between the two arms. Diastolic blood pressure and heart rate did not change between groups during the study period.
“We are highly encouraged by these promising double-blind, randomised results with BackBeat CNT in the MODERATO II study,” says David Hochman, chairman and CEO of Orchestra BioMed. “We plan to use these results to help design registrational studies to support FDA [Food and Drug Administration] and other global regulatory approvals for devices delivering BackBeat CNT, and will be working to forge strategic collaborations to accelerate making this potentially high-impact therapy available to patients with known unmet needs.”
According to the press release, BackBeat CNT mimics the effects of multidrug hypertension therapy by targeting preload, afterload, and sympathetic tone. BackBeat CNT’s initial target are patients with uncontrolled hypertension who are also indicated for a pacemaker. Orchestra BioMed has a global strategic partnership with Terumo Corporation for the development and commercialisation of Virtue SEB (sirolimus eluting balloon).