MODERATO II Control Patients Crossover Extension Study Results Presented

Orchestra BioMed

NEW HOPE, PA — Orchestra BioMed™, Inc. recently announced the presentation of positive long-term clinical results from the MODERATO II Control Patients Crossover Extension Study of BackBeat Cardiac Neuromodulation Therapy™ (“BackBeat CNT”) at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual conference being held in Boston, MA. BackBeat CNT is a bioelectronic therapy candidate that is compatible with standard pacemakers and designed to lower blood pressure.

MODERATO II was a European prospective, multi-center, randomized, double-blind pilot study investigating the efficacy of BackBeat CNT in patients with an indication for a pacemaker and persistent hypertension despite one or more anti-hypertensive medications. In the study, patients were randomized to treatment (BackBeat CNT plus continued medical therapy) or control (continued medical therapy) groups. Previously reported data on the study’s primary endpoint showed a clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure (“aSBP”) at 6 months in favor of BackBeat CNT.

Following completion of the randomized period and successful achievement of the primary endpoints, 14 control patients crossed over to active BackBeat CNT. Nine of the 14 patients had isolated systolic hypertension (“ISH”), a more difficult-to-treat form of hypertension characterized by elevated systolic blood pressure paired with normal or low diastolic blood pressure. The long-term results in these patients were encouraging and consistent with the reductions in the BackBeat CNT group during the randomized portion of the study and are summarized below:

  • Statistically significant mean reductions in aSBP (-10.3±9.3 mm Hg, p<0.01) and ambulatory pulse pressure (aPP, -11.7±5.5 mmHg, p<0.01) at 6 months post-therapy activation compared to pre-crossover
  • Minimal changes in mean ambulatory diastolic blood pressure (aDBP, +1.5±5.5 mmHg, p=NS) at 6 months post-therapy activation compared to pre-crossover, a potentially important result for ISH patients
  • Mean office systolic blood pressure, oSBP, decreased by 13.1±26.6 and 13.8±28.7 mmHg at 6 and 18 months post-therapy activation, respectively, compared to pre-crossover
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“The long-term results in crossover patients are encouraging as they provide additional support that BackBeat CNT has the potential to deliver sustained and clinically meaningful reductions of systolic blood pressure in hypertensive patients indicated for a pacemaker,” said Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation, who presented the study findings. “The ability to reduce systolic pressure and pulse pressure while simultaneously controlling impact on diastolic pressure, may provide a unique therapeutic option for a broad range of patients, including the majority of this population, which suffers from isolated systolic hypertension.”

In June 2022, Orchestra BioMed entered into an exclusive license and collaboration agreement with Medtronic for the development and commercialization of BackBeat CNT as a potential treatment for hypertension in patients who are indicated for a cardiac pacemaker. This strategic collaboration is structured to provide Orchestra BioMed with development, clinical, and regulatory support for a planned global pivotal trial of BackBeat CNT in hypertensive patients who have been indicated for, and recently received, a cardiac pacemaker implant. Initiation of the trial is expected in the second half of 2023. Upon regulatory approval, Medtronic will have the global rights to commercialize BackBeat CNT-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the BackBeat CNT-enabled pacing systems.

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