electroCore Announces Positive Top-Line Results from PREMIUM II Migraine Prevention Study
All study endpoints showed benefit from non-invasive vagus nerve stimulation, with many endpoints showing a statistically significant improvement with nVNS compared to sham stimulation
BASKING RIDGE, N.J., Dec. 08, 2020 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today top-line results from its GM-US-10 (PREMIUM II) study. Despite the early termination of the study in April 2020 due to the COVID-19 pandemic, all study endpoints, including several patient-assessed quality of life measures, showed benefit from non-invasive vagus nerve stimulation (nVNS), with many endpoints showing a statistically significant improvement with nVNS compared to sham stimulation.
In the predefined modified intent to treat population (mITT; n=113), which was the designated primary analysis population for the study, patients using gammaCore™ nVNS had 3.1 less migraine days over the final four weeks of the 12 week double blind study period versus the four weeks of the run-in period as compared to a decrease of 2.3 migraine days in the sham group (primary endpoint; p=0.233).
Within the mITT population, 44.9% of the subjects using gammaCore™ nVNS had at least a 50% decrease in the number of migraine days compared to 26.8% for those receiving sham stimulation (secondary endpoint; p=0.048). Patients using gammaCore also reported a statistically significant decrease in migraine associated disability and improvement in their quality of life across all of the quality of life (QOL) endpoints in the study.
Of particular interest were the results in the predefined sub-population of patients diagnosed as having migraine with aura. In this group, patients using nVNS had 5.5 fewer headache days compared to 2.7 fewer headache days in the sham group (p=0.041). There were no serious adverse effects reported in the study, which is consistent with nVNS’ strong safety and tolerability profile.
Complete results of the study are expected to be published in early 2021 in a peer reviewed neurology journal. gammaCore™ received 510(k) clearance for the preventative treatment of migraine on March 26, 2020.
Dr. Umer Najib, MD, FAHS, Director of the West Virginia University Headache Center and an investigator in the PREMIUM II study, commented “I am pleased that nVNS continues to demonstrate its ability to effectively decrease the migraine burden in patients who need preventive therapy. The strong benefit seen in patients diagnosed with aura is particularly interesting as those patients can often be particularly difficult to treat.”
“The results of the PREMIUM II study highlight the unique role gammaCore nVNS can play as the only headache treatment that has demonstrated an ability to decrease the number of migraine days a patient experiences while also being able to treat the acute pain of migraines that occur in spite of a preventive regimen,” said Eric Liebler, SVP of Neurology at electroCore, Inc. “Although the ongoing COVID-19 pandemic negatively impacted our ability to fully enroll PREMIUM II, our analysis indicates we likely would have reached statistical significance on all of our predefined endpoints had the study reached its original enrollment targets. With FDA clearances for the acute and preventive treatment of both cluster and migraine headache, gammaCore continues to differentiate itself as one of the most effective, safe and flexible treatments available to help patients looking for a way to take control of their headache treatment.”
PREMIUM II was a randomized, double-blind, sham-controlled clinical trial of gammaCore™ for the prevention of migraine conducted at over 30 sites in the United States (ClinicalTrials.gov identifier NCT03716505). The study was originally designed based on mITT of approximately 300 subjects. The study was closed before reaching its original enrollment targets in Q2 of 2020 due to the impact of COVID-19 on the conduct of clinical trials, resulting in intent to treat (ITT) and mITT groups of 228 and 113, respectively.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCoreTM (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 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, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine 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.
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- 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
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore 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 their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the expected date of publication of complete study results from the PREMIUM II trial 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.