Etripamil Nasal Spray Shows Positive Phase III Results for PSVT Treatment in China
核心洞察
Ji Xing Pharmaceuticals (搜索)' Phase III trial of etripamil nasal spray met its primary endpoint, showing a statistically significant conversion to normal heart rhythm within 30 minutes compared to placebo.
The trial, conducted across 40 hospitals in China, demonstrated that 40.5% of patients converted to sinus rhythm with etripamil versus 15.9% with placebo.
Secondary efficacy endpoints were also met, with treatment-emergent adverse events being comparable between the etripamil and placebo groups, and no serious adverse events reported.
Ji Xing Pharmaceuticals (搜索) has announced positive topline data from its Phase III clinical trial evaluating etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (搜索) (PSVT (搜索)). The randomized, multi-center, double-blind, placebo-controlled trial, conducted across more than 40 hospitals in China, enrolled 500 subjects to assess the efficacy and safety of the self-administered nasal spray.
Trial Design and Results
Subjects were randomized in a 1:1 ratio to receive either etripamil (70mg) or placebo nasal spray, with the option to self-administer a second dose after ten minutes if symptom relief was not achieved. The primary endpoint was met, with a Kaplan Meier analysis indicating a statistically significant greater proportion of subjects converted to a normal rhythm within 30 minutes when using etripamil versus placebo (40.5% vs. 15.9%, p<0.001; hazard ratio [HR] = 3.00; 95% CI 1.58-5.71).
Secondary efficacy endpoints were also met at various time points up to 60 minutes post-administration. Treatment-emergent adverse events (TEAEs) were comparable between the etripamil and placebo arms, and no serious adverse events linked to etripamil were reported. The majority of common adverse events, occurring within 24 hours of administration, were associated with the nasal delivery method.
Clinical Significance and Future Plans
PSVT (搜索) is characterized by episodes of sudden-onset rapid heartbeats, often exceeding 150 to 200 beats per minute, affecting an estimated two million people in the United States. These episodes can cause disabling palpitations, shortness of breath, and chest discomfort, significantly impacting patients' daily activities. Current treatment options often require emergency department visits or invasive cardiac procedures.
“We will engage with the regulatory authorities to advance the new drug application for etripamil with the aim of bringing this innovative therapy to patients with PSVT (搜索) in China as soon as possible,” said Yuan Li, Cardiovascular chief medical officer at Ji Xing Pharmaceuticals (搜索). “Once etripamil gains approval, we are confident that it will not only empower patients to self-manage their PSVT episodes but will also create significant value for the entire healthcare system by reducing the frequency of emergency department visits.”
Collaboration and Licensing
Milestone Pharmaceuticals Inc., the licensor of etripamil, granted Ji Xing an exclusive license to develop and commercialize etripamil in Greater China. Milestone received an upfront cash payment of $15 million and a $5 million equity investment. Milestone remains eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China.