Phase 2 Trial Updates on Sotatercept in Treating PAH Set for ATS 2021
Treatment with Acceleron Pharma’s sotatercept appears to be effective and generally well tolerated in people with pulmonary arterial hypertension (PAH), according to new data from the ongoing PULSAR and SPECTRA Phase 2 clinical trials.
These data will be presented at the American Thoracic Society (ATS) 2021 International Conference to be held virtually on May 14–19.
“It’s quite gratifying to return to the ATS International Conference with new sotatercept data, having first presented topline results from the PULSAR trial during a special breaking news session at ATS 2020 Virtual,” Habib Dable, president and CEO of Acceleron, said in a press release.
“The results to be shared this year strengthen our confidence in sotatercept’s potential to become a backbone therapy for patients with PAH,” Dable added.
The PULSAR and SPECTRA presentations are scheduled for Wednesday, May 19.
Sotatercept is a lab-made protein designed to rebalance signaling between pro- and anti-proliferative pathways, namely the bone morphogenic protein (BMP) signaling pathway that is known to play a key role in the maintenance of healthy lung blood vessels. Disturbances in the BMP pathway have been associated with the development of PAH.
In keeping with the top-line, 24-week findings announced in 2020, 48-week interim data from the open-label extension of the PULSAR Phase 2 trial (NCT03496207) shows consistent or improved responses in safety and efficacy measures with sotatercept’s use. These findings are detailed in the ATS 2021 abstract, “PULSAR study open-label extension: interim results from a Phase 2 study of the efficacy and safety of sotatercept when added to standard of care for the treatment of pulmonary arterial hypertension (PAH).”
Nine of these 10 patients reported treatment-related adverse events, and one discontinued treatment.
“In this preliminary analysis of patients in the ongoing SPECTRA study, encouraging results in hemodynamics and exercise tolerance and capacity were seen. Safety was consistent with previous reports in PAH and other patient populations,” the researchers wrote in the abstract.
These data also highlight “the clinical efficacy of sotatercept and its potential as a new treatment option for PAH patients,” the team added.
SPECTRA is due to finish collecting patient data in December 2021, and to conclude in December 2022.
These two ATS 2021 presentations will offer additional findings not in their abstracts.
At ATS 2021, Acceleron will also present preclinical data on the effects of sotatercept in animal models of PAH and pulmonary hypertension. The company is also planning to test sotatercept’s potential as a PAH therapy in multiple Phase 3 trials.