electroCore Announces Publication of PREMIUM II Trial of gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) for the Prevention of Migraine

Rhea-AI Summary

electroCore, Inc. (Nasdaq: ECOR) announced a peer-reviewed publication regarding its nVNS therapy for migraines, specifically from the PREMIUM II trial. Conducted across 27 U.S. sites, the study initially aimed to enroll 400 patients but closed with 231 due to COVID-19. Results showed a statistically significant reduction in monthly headache days (4.6 vs -3.0 for sham, p=0.05) and enhanced quality of life metrics. The therapy demonstrated particular efficacy in patients with migraine with aura, with a 5.5-day decrease in headache days. The findings underscore the potential of gammaCore for various migraine treatments.

Positive

• Publication of peer-reviewed study validates nVNS therapy effectiveness for migraines.
• Statistically significant reduction in headache days by 4.6 days in nVNS group compared to sham.
• 44.87% of nVNS subjects experienced over 50% reduction in migraine days.
• Study highlights efficacy in migraine with aura, showing 5.5-day decrease in headache days.

Negative

• Study was prematurely closed due to COVID-19, resulting in only 231 enrolled subjects instead of targeted 400, potentially limiting data robustness.

ROCKAWAY, N.J., Jan. 10, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper, entitled “Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial” in Cephalalgia, the official journal of the International Headache Society (IHS). The paper reports the results of a randomized, double-blind, sham-controlled trial conducted at twenty-seven sites across the United States. Originally designed and powered to randomize 400 patients, the study was closed early due to COVID-19 after enrolling 231 subjects.

The results of the study showed a decrease in the number of monthly headache days of 4.6 vs. -3.0 for sham (p=0.05) with 44.87% of subjects in the gammaCore group having greater than a 50% reduction in the number of migraine days per month compared with 26.81% for the sham group (p=0.05). Quality of life, as measured by the HIT-6 (Headache Impact scale), improved by -4.9 points vs. -2.3 for sham (p<0.05). In the subpopulation of patients diagnosed with migraine with aura, the number of headache days decreased by 5.5 days in the nVNS group compared with 2.7 in the sham group (p=0<0.05), a therapeutic gain of >100% compared to sham. These findings are consistent with previous reports on the mechanisms of action that suggest nVNS may be particularly effective in patients with migraine with aura.

Dr. Umer Najib, Associate Professor, Program Director of the Headache Medicine Fellowship Program at the West Virginia University and first author of the paper commented, “We are pleased to have added to the data that helps suggest the types of migraine patients who could likely benefit most from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or adjunctive treatment, depending on the needs of the patient, and its flexibility allows health care providers to consider it for many of their patients.”

“We congratulate and thank all of the investigators, site staff, and subjects who conducted this study throughout the United States despite the challenges that arrived with COVID-19,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the findings of this study highlighting the potential benefits in patients who have migraine with aura are particularly compelling.”

The full publication is available at: https://journals.sagepub.com/doi/10.1177/03331024211068813

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with migraine with aura, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com

FAQ

What are the results of the PREMIUM II trial published by electroCore?

The PREMIUM II trial demonstrated a significant reduction in headache days for nVNS users, with 4.6 fewer headache days compared to the sham group, and better quality of life metrics.

What percentage of patients experienced significant improvements using gammaCore?

In the trial, 44.87% of subjects using gammaCore reported more than a 50% reduction in migraine days.

Why was the PREMIUM II trial halted early?

The trial was closed early due to COVID-19, which resulted in 231 patients being enrolled instead of the planned 400.

What is the significance of the study for patients with migraine with aura?

The study found that patients with migraine with aura experienced a 5.5-day reduction in headache days when treated with nVNS, indicating notable efficacy.

How does gammaCore work in treating migraines?

gammaCore is a non-invasive device that stimulates the vagus nerve at the neck, helping to alleviate migraine and headache pain.