FDA clears investigational new drug application for lorundrostat in OSA, hypertension
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The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, lorundrostat, in adults with obstructive sleep apnea and hypertension, according to a press release.
“The trial builds on positive results in several small prior trials of mineralocorticoid receptor antagonists that demonstrated reduction in the severity of upper airway obstruction in obese patients with OSA,” David Rodman, MD, chief medical officer at Mineralys Therapeutics, told Healio.
In the multisite, placebo-controlled, crossover trial, the release noted that researchers will assess approximately 40 adults with moderate to severe OSA and a BMI of 27 kg/m2 or higher to determine how nightly 50 mg lorundrostat (Mineralys Therapeutics) impacts the number of apnea-hypopnea episodes and nighttime blood pressure (BP). The drug’s safety profile in this specific patient population will also be established.
“The trial will be using state-of-the art, continuous measurements of nighttime BP to generate thousands of data points, allowing us to precisely characterize the effect of lorundrostat on nighttime BP far more effectively than conventionally used techniques,” Rodman told Healio.
As Healio previously reported, the Target-HTN trial showed that lorundrostat was associated with clinically significant reductions in automated office BP for people with uncontrolled hypertension, with the greatest effects seen in people with concomitant obesity.
“Based on our positive BP lowering results in obese patients with hypertension, we anticipate that lorundrostat will not only reduce airway obstruction, but also safely reduce the severe nighttime hypertension seen in these patients,” Rodman said.
When asked why this trial is important for clinicians treating OSA, Rodman told Healio that many patients struggle with regular CPAP use. He added that nighttime BP has not been a focus point in OSA treatments.
“CPAP and other devices can help alleviate upper airway obstruction when used consistently and throughout the night, but there are compliance issues and, most notably, there aren’t treatments that have proven to also address the elevated nighttime BP that is strongly linked to OSA,” Rodman said.
“OSA is considered an independent risk factor for all-cause mortality and morbidity,” Rodman continued. “The negative and additive cardiovascular effects of OSA and hypertension highlight the importance of effectively managing these conditions, especially when they coexist in the same patient, so we hope to eventually provide clinicians with a therapeutic option that addresses both.”
According to Rodman, this trial is expected to start in quarter one of 2025.
“Airway disease usually takes around 4 weeks to get better with proper treatment, and we believe that blood pressure response will also be manifested in 4 weeks,” Rodman told Healio. “We plan to provide an update in the future regarding topline data readout from Explore-OSA.”