JIXING Announces Positive Results from Phase 3 JX02002 Clinical Trial of Etripamil Nasal Spray in Patients with PSVT

SHANGHAI, China, September 6, 2024 – Ji Xing Pharmaceuticals Limited (JIXING), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, today announces positive topline data from the Phase 3 JX02002 clinical trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) in China. The trial met its primary endpoint.

The Phase 3 clinical study of etripamil conducted by JIXING is a multi-center, randomized, double-blind, placebo-controlled trial in more than 40 hospitals nationwide, with a total of 500 patients enrolled, aiming to evaluate the efficacy and safety of etripamil nasal spray. The drug is self-administered by patients, who experience an episode of PSVT in an at-home setting. Patients were randomized 1:1 to a nasal spray of either etripamil (70 mg) or placebo without medical supervision. To maximize the potential treatment effect of etripamil, patients who did not experience symptom relief within 10 minutes were directed to self-administer a repeat dose of study drug.

The trial met its primary endpoint, a Kaplan Meier analysis shows a statistically significantly greater proportion of patients who took etripamil converted within 30 minutes compared to placebo (40.5% vs. 15.9%; hazard ratio [HR] = 3.00; 95% CI 1.58-5.71; p<0.001). Statistically significant (p<0.05) efficacy results were also observed for the secondary efficacy endpoints for the timepoint of 10, 15, 45 and 60 minutes.

Overall, the treatment emergent adverse events (TEAEs) were comparable between etripamil and placebo group. There were no reported serious AEs related to etripamil. The majority of the most common randomized treatment emergent adverse events（RTEAEs, which occurred within 24 hours of study drug administration, were related to the nasal administration site. The safety and tolerability data from JX02002 trial continue to support the potential self-administration use of etripamil, with findings consistent with those observed in prior trials.

JIXING plans to present data from the trial at a medical conference soon and to submit these data to regulators.

"The results from the Phase 3 clinical trial of etripamil in China are exciting. Significantly more patients administering etripamil converted PSVT to normal sinus rhythm compared to patients administering placebo. Of particular note is that etripamil did not cause any serious adverse events, self-administered in a setting without medical supervision, demonstrating that its safety profile has been effectively validated, ”said Professor Changsheng Ma, Principal Investigator of the etripamil Phase 3 study in China, Chairman-designate of the Cardiovascular Branch of the Chinese Medical Association, Director of National Clinical Research Center for Cardiovascular Diseases, Director of Cardiology Center of Beijing Anzhen Hospital of Capital Medical University. “These solid clinical data reinforce etripamil as a potentially clinically valuable drug that not only provide a new, convenient and effective treatment option for patients with PSVT, but could also provide healthcare professionals with a reliable and efficient treatment option. We believe that etripamil will open up new treatment pathways for Chinese patients with PSVT, allowing them to access effective treatment options quickly and conveniently even in non-hospital settings. This will undoubtedly greatly enhance patients' quality of life and treatment experience.”

Approximately 2.3-4 in 1,000 people have PSVT, resulting in an estimated overall patient population of 3-6 million in China. Currently, termination of acute episodes requires emergency-setting administration of IV calcium channel blockers and IV antiarrhythmic drugs. Patients typically have multiple, unpredictable PSVT episodes per year, leading to a significant impact on their quality of life.

“We are sincerely grateful for the strong support and commitment of the entire research team and all participants, led by Prof. Changsheng Ma from Beijing Anzhen Hospital and from more than 40 medical institutions across China,” Yuan Li, MD, Chief Medical Officer of Cardiovascular at JIXING，expressed her gratitude. ”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 in China as soon as possible. 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."

About PSVT

Approximately 2.3-4 in 1,000 people have PSVT, resulting in an estimated overall patient population of 3-6 million in China. PSVT is characterized by intermittent episodes of a rapid heartbeat that starts suddenly and unpredictably. Episodes of supraventricular tachycardia (SVT) are often associated with symptoms such as palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain intravenous medications, including adenosine, beta-blockers, and calcium channel blockers, have long been used for the acute treatment of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, a new chemical entity, is the lead investigational product of Milestone? Pharmaceuticals Inc. (Nasdaq: MIST). It is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to a medically unsupervised setting. In May 2021, JIXING and Milestone entered into an exclusive license agreement for the development and commercialization of the investigational drug etripamil for the treatment of PSVT and other cardiovascular diseases in Greater China.

About JIXING

JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China and around the world with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in China and around the world.

JIXING's cardiovascular portfolio includes 5 assets in clinical development aficamten、etripamil，omecamtiv mecarbil，JX09 and JX10）. JIXING's ophthalmology portfolio includes 4 assets in late-stage clinical development (varenicline solution nasal spray/US brand name TYRVAYA?, OC-02 nasal spray, JX06/LNZ100, JX07/LNZ101) and 1 asset in pre-clinical stage (JX08).? For further information about JIXING, please visit www.jixing.com.?

References:

1. Chiang JK, Kao HH, Kao YH. Association of Paroxysmal Supraventricular Tachycardia with Ischemic Stroke: A National Case-Control Study. Journal of Stroke and Cerebrovascular Diseases (2017); 26(7):1493-1499.
2. Chan CL, Li AA, Chung HA, Phan DV. Cost Effectiveness Analysis and Payment Policy Recommendation-Population-Based Survey with Big Data Methodology for Readmission Prevention of Patients with Paroxysmal Supraventricular Tachycardia treated with Radiofrequency Catheter Ablation. International Journal of Environmental Research and Public Health (2020); 17(7):2334.
3. Ho HH, Yeh SJ, Tsai WP, et al. Paroxysmal supraventricular tachycardia and Wolff-Parkinson-White syndrome in ankylosing spondylitis: a large cohort observation study and literature review. Seminars in Arthritis and Rheumatism (2012); 42(3):246-53.
4. Orejarena LA, Vidaillet H Jr, DeStefano F, et al. Paroxysmal supraventricular tachycardia in the general population. Journal of the American College of Cardiology (1998); 31(1):150-7.