electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

June 2, 2021 at 7:30 AM EDT

ROCKAWAY, N.J., June 02, 2021 (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 Improves Clinical and Molecular Biomarkers of Parkinson’s Disease in Patients with Freezing of Gait” in the journal NPJ Parkinson’s Disease. The paper reports the results of a randomized, double-blind, sham-controlled crossover trial conducted at the Institute of Neurosciences in Kolkata, India in collaboration with the Faculty of Medical Sciences at Newcastle University in England using gammaCore SapphireTM. The study was funded by the Institute of Neurosciences, Kolkata, India.

Neurological disorders are now the leading source of disability in the world, and Parkinson’s disease is the fastest-growing of these disorders. As populations age and life expectancy increases, the number of individuals with Parkinson’s disease and the duration of the disease will increase, leading to more patients with advanced Parkinson’s disease. To address this burden, primary prevention strategies based on the underlying causes of Parkinson’s disease and more effective symptomatic treatments are needed.1 There are over 1 million individuals diagnosed with Parkinson’s disease in the United States with an estimated total annual economic burden of $51.9 billion.2

The study, which enrolled thirty-six subjects, was undertaken to explore the safety, feasibility and efficacy of self-administered non-invasive vagus nerve stimulation (nVNS) in the treatment of gait and other motor symptoms in Parkinson’s disease (PD) patients. In a subgroup of study patients, levels of selected neurotrophins, markers of inflammation and oxidative stress were measured in blood before and after nVNS.

Vagus Nerve Stimulation (VNS) has been found to be beneficial in improving locomotion in a rat model of PD,3 and two independent preliminary studies found improvement in gait in patients with PD after a single application of cervical nVNS.4,5

The study provides preliminary evidence supporting the safety and efficacy of nVNS in treating motor and non-motor symptoms of PD. Patients were satisfied with the treatment and the majority were able to self-administer nVNS. Adverse events were infrequent, non-serious, and similar across both Active and Sham groups. Significant increases in velocity (p=0.003), step length (p=0.007), and a reduction in stance time (p=0.001) were seen in the nVNS treated group compared to sham stimulation, indicating that PD patients were walking not only with a faster pace but also with improved rhythm. Other gait parameters also showed significant improvement from baseline in all five domains, specifically after nVNS treatment, suggesting that nVNS may result in an overall improvement in the quality of gait in PD patients. Treatment with nVNS significantly reduced TNF-α levels (p<0.05) and increased concentrations of reduced glutathione (p<0.05), which are both markers of inflammation in PD patients. Brain Derived Neurotrophic Growth Factors, which are reduced in PD, were significantly increased by nVNS (p<0.05) suggesting a possible disease modifying effect.

Dr. Hrishikesh Kumar, Director of Research and Vice Chairman of the Institute of Neurosciences Kolkata and lead investigator of the study, commented, “We are pleased to have successfully completed the first randomized, double-blind sham-controlled trial to demonstrate the efficacy of cervical nVNS as an adjunctive therapy in PD. Improvements in motor function and gait after one month of treatment with nVNS were significant. Our results clearly support additional work to further understand the potential for nVNS in this indication.”

“We congratulate and thank Dr. Kumar, Dr. Baker and the clinical and research teams in Kolkata, India and Newcastle, England, as well as the patients and families that participated in this study,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “Parkinson’s disease is the fastest growing neurodegenerative disease in the United States. The impact of PD on patients and their families is devastating and the cost to the healthcare system is staggering. electroCore is looking forward to continuing research to bring nVNS to patients with PD.”

The full publication is available at: https://www.nature.com/articles/s41531-021-00190-x

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 for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM
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, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and 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 pacemaker, hearing aid implant, or 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:
    • 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 of age)
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all 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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat Parkinson’s disease or patients with freezing of gait and related disorders 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.

1 GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953.

2 Yang W, Hamilton JL, Kopil C, Beck JC, Tanner CM, Albin RL, Ray Dorsey E, Dahodwala N, Cintina I, Hogan P, Thompson T. Current and projected future economic burden of Parkinson's disease in the U.S. NPJ Parkinsons Dis. 2020 Jul 9;6:15.

3 Farrand, A. Q. et al. Vagus nerve stimulation improves locomotion and neuronal populations in a model of
Parkinson's disease. Brain stimulation 10, 1045-1054 (2017).
4 Mondal, B. et al. Analysis of gait in Parkinson’s disease reflecting the effect of l-DOPA. Annals of
Movement Disorders 2, 21 (2019).
5 Morris, R. et al. Noninvasive vagus nerve stimulation to target gait impairment in Parkinson's disease.
Movement Disorders (2019).


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

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Media Contact:
Summer Diaz
electroCore
973-290-0097
summer.diaz@electrocore.com

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