electroCore, Inc. Provides Update on nVNS to Treat Post Traumatic Stress Disorder

Rhea-AI Summary

electroCore, a commercial-stage bioelectronic medicine company, provided an update on its clinical research using gammaCore (nVNS) to treat Post Traumatic Stress Disorder (PTSD). A recent study demonstrated a 31% reduction in PTSD symptoms among 20 patients after three months of treatment with nVNS compared to a sham device. The company is currently conducting two randomized, sham-controlled clinical trials to further evaluate the efficacy of nVNS in treating PTSD. CEO Dan Goldberger highlighted gammaCore's potential as a safe and effective treatment, with regulatory updates expected in 2022.

Positive

• 31% reduction in PTSD symptoms observed in clinical study (p<0.013)
• Ongoing collaboration in two additional randomized clinical trials
• gammaCore presents potential for treating PTSD alongside existing FDA approvals

Negative

• None.

ROCKAWAY, NJ, Dec. 14, 2021 (GLOBE NEWSWIRE) --  electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today provided an update on the ongoing clinical research to assess the potential of gammaCore (non-invasive vagal nerve stimulation; nVNS) to treat Post Traumatic Stress Disorder (“PTSD”).

PTSD is a debilitating disorder triggered by experiencing or witnessing a traumatic event that is increasingly common. Approximately 15 million adults in the US will have PTSD during a given year and it is particularly concerning to the Military and Veteran’s Administration (VA).

In a study published on December 6^th, 2021, in the Journal of Affective Disorders Reports, 20 patients suffering from PTSD were exposed to personalized traumatic scripts followed by an immediate stimulation by an active or sham non-invasive vagus nerve stimulator (“nVNS”). The results showed that three-months of treatment with nVNS led to a 31% reduction (p<0.013) in PTSD symptoms compared to sham on the PTSD Checklist (“PCL”), as well as a significant decrease in hyperarousal symptoms (p=0.008) and a decrease in overall and somatic (gastric) anxiety. At the conclusion of the study, patients who continued using nVNS for a further 3 month open-label period showed significant improvement in their overall symptoms reported by the Clinical Global Index (p=0.003). Furthermore, nVNS effectively blocked the increase in the levels of the inflammatory cytokine IL-6 that is overexpressed in patients with PTSD who are exposed to a traumatic script (p<0.05).

electroCore is currently collaborating with investigators on two Randomized, sham-controlled clinical trials to further confirm the efficacy of nVNS as a treatment for PTSD. (Table 1)

Table 1. Ongoing Studies of nVNS in PTSD and Related Disorders
Study	Size	Location
nVNS in posttraumatic stress	88	VA San Diego Healthcare System, San Diego, CA
Sympathetic overactivity in PTSD	100	Atlanta VA Medical Center, Decatur, GA

“PTSD is a devastating condition that affects family and individuals across the United States. Whether it affects our active-duty service men and women, our Veteran’s, or friends and family, there are very few treatments that can decrease the signs and symptoms of nVNS” said Dan Goldberger, CEO of electroCore. “gammaCore, which is currently cleared by the FDA for most forms of primary headache, offers the potential to provide a safe, convenient and effective treatment for people with PTSD. We look forward to reporting on our clinical and regulatory progress in 2022.”

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 Post Traumatic Stress Disorder (PTSD), 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.

FAQ

What were the results of the recent PTSD study by electroCore?

The study showed a 31% reduction in PTSD symptoms after three months of treatment with gammaCore (nVNS) compared to a sham device.

What is the significance of electroCore's ongoing clinical trials for nVNS?

These trials aim to further confirm the efficacy of nVNS as a treatment for PTSD, potentially expanding its market application.

When can we expect updates on electroCore's clinical and regulatory progress?

Updates are expected in 2022 regarding the clinical and regulatory progress of electroCore's treatments.

How many patients were involved in the electroCore PTSD study?

The study involved 20 patients suffering from PTSD.

What impact does nVNS have on inflammatory cytokines in PTSD patients?

nVNS effectively blocked the increase of IL-6, an inflammatory cytokine, in patients exposed to traumatic scripts.