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Since Our Last Update
Since our last update, electroCore Inc. (NASDAQ:ECOR) has provided several updates including a 2021 Shareholder Letter, completion of enrollment of its TRANSIT study in post-operative ileus, and three abstracts presented at the International Stroke Conference with promising early data.
Highlights since our last update include:
➢ Shareholder letter and 2021 business update - January 2022
➢ Three abstracts presented at International Stroke Conference 2022 - February 2022
➢ TRANSIT completes enrollment - February 2022
➢ nVNS stroke data at 2022 International Stroke Congress - February 2022
Shareholder Letter and 2021 Business Update
In its January 18th Letter to Shareholders, electroCore’s Board provided a review of the company’s long-term prospects and update on progress. The Letter reminded investors of the recently launched UK and US e-commerce storefronts that make gammaCore available directly to consumers at a compelling price, and discussed plans to ramp-up advertising spend aggressively to support the channel. In parallel with the online stores, electroCore launched gConcierge and gCDirect programs allowing physicians to prescribe gammaCore therapy for patients who can then directly purchase the product via the doctor’s office directly from electroCore. The company also broadened its call points to include a wider range of medical providers who manage headache conditions. 200 prescribers have utilized gConcierge and gCDirect to write scripts. The Department of Veterans Affairs (VA) and DoD channels will receive continued investment and advertising support. The company expects that its newly launched cash-pay programs will address the deterrence posed by high-deductible insurance plans. On the development side of the business, multiple clinical programs are ongoing over the course of 2022. These programs include secondary headache, traumatic brain injury, PTSD, stroke, opioid use disorder, Parkinson’s disease, postoperative ileus and others.
Abstracts Presented at International Stroke Conference 2022
electroCore presented three abstracts at the International Stroke Conference 2022 and disclosed details on the presentations in a February 9th press release.
The three posters presented included:
➢ Non-invasive Vagus Nerve Stimulation for The Acute Treatment of Ischemic or Hemorrhagic Stroke;
➢ Effect Of Non-invasive Vagus Nerve Stimulation in Hemorrhagic Brain Injury and Permanent Ischemic Stroke in Rats; and
➢ Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke.
The moderated poster “Non-invasive Vagus Nerve Stimulation for The Acute Treatment of Ischemic or Hemorrhagic Stroke” presented results from TR-VENUS, a randomized, sham controlled, multi-center study conducted at nine academic centers in Turkey. The intent-to-treat (ITT) population included 69 subjects (61 ischemic stroke and eight intracerebral hemorrhage) distributed into three treatment arms: sham (n=25), standard-dose nVNS (n=19), and high-dose nVNS (n=25). The standard dose nVNS administered seven stimulations over one hour, while the high-dose administered seven stimulations in hour 1 and hour 5. 97% of randomized studies received their first stimulation less than 6 hours from stroke onset. The study met all primary safety, and secondary safety and feasibility endpoints. Of particular interest were measures of relative infarct growth. While the sham group had infarct growth of ~186% from baseline, the high-dose nVNS arm had infarct growth of only ~63%, significant at the 95% level of confidence. Achieving statistical significance with limited trial size and the marked suppression of infarct growth support electroCore’s continued pursuit of this indication. Furthermore, prior animal studies in stroke have struggled to translate in humans, making TR-VENUS’ patient results noteworthy.
The poster “Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke (NOVIS)” updated enrollment trends for NOVIS, a prospective randomized clinical trial with blinded outcome assessment being conducted at the Leiden University Medical Center. 50% of subjects have been enrolled as of February 9, 2022. The trial is targeting 150 subjects randomized 1:1 into five days of nVNS plus standard treatment versus treatment alone. Primary endpoint is final infarct volume on day five. NOVIS features a greater number of nVNS stimulations over the five days than TR-VENUS. Advanced imaging endpoints including measurement of the injured tissue surrounding the ischemic core (penumbra) that will provide additional insight into the role of nVNS in acute ischemic stroke.
The third poster presented by Dr. Ay was “Effect of Non-invasive Vagus Nerve Stimulation in Hemorrhagic Brain Injury and Permanent Ischemic Stroke in Rats,” a preclinical study of nVNS in ischemic stroke that found a lack of adverse events in two different validated rat models of intracerebral hemorrhage suggesting that nVNS can be administered safely before the stroke etiology has been determined.
The Opportunity in Stroke
According to the CDC,2 in 2018 one in six deaths from cardiovascular disease was due to stroke, and 795,000 people in the US have a stroke every year, and for about 610,000 of these individuals, it is the first stroke. The majority of strokes are ischemic (87%). Stroke-related costs in the US totaled approximately $46 billion between 2014 and 2015. More importantly, early intervention is critical in stroke. The earlier the intervention, the better the outcome. Early intervention helps avoid hypoxic injury to the brain and even death. Patients who arrive at the emergency room within three hours of their first symptoms often have fewer disabilities three months after the event compared to those who receive delayed care. In general, infarct volume has been shown to correlate with patient outcomes.3 Because nVNS appears to be safe in either ischemic or hemorrhagic stroke, if approved nVNS can be applied safely and immediately, such as in the ambulance, to intervene with stroke damage progression. Later, typical imaging can be performed to define the type of stroke and standard of care can follow. Transportation and imaging cost valuable time, diminishing patient outcomes. Although more data is required, nVNS may even qualify for expedited review by the FDA for this indication given the lack of other treatment and the unmet need.
TRANSIT Study in Post-Operative Ileus Enrollment Completed
On February 1, 2022, electroCore announced that it had completed enrollment for its TRANSIT study of nVNS in ileus after colorectal surgery. TRANSIT is a randomized, participant blinded, sham-controlled study that is sponsored by the UK National Institute for Health Research (NIHR). The 97-patient study is led by Dr. Stephen Chapman, Clinical Research Fellow in the University of Leeds School of Medicine and is conducted at St. James Hospital and Bradford Royal Infirmary. Clinical endpoints include the number of postoperative days to first flatus, first stool, first oral intake, hospital discharge, and the GI-2 composite outcome.4 Daily oral morphine equivalent requirements, as well as a number of safety and feasibility outcomes to inform potential future clinical research and use, will also be assessed. Study results are expected later this year.
Since our last report, electroCore has posted several updates including its 2021 Shareholder Letter and Business Update, three abstracts presented at the International Stroke Conference 2022, and the completion of enrollment in the TRANSIT study. Results from TR-VENUS showed that high-dose nVNS was able to suppress infarct growth at 63% versus 186% in sham. Although intended as a safety and feasibility study and despite limited population size, efficacy results already achieved statistical significance. These promising preliminary data warrant further clinical inquiry into an indication that affects ~800,000 people in the US per year.6
electroCore has many factors in its favor which are helping to expand its presence globally to support its attractive profile. Additional indications, including stroke, are also longer-term opportunities.
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3. Ospel, J. M., Hill, M. D., Menon, B. K., Demchuk, A., McTaggart, R., Nogueira, R. & Goyal, M. (2021). Strength of Association between Infarct Volume and Clinical Outcome Depends on the Magnitude of Infarct Size: Results from the ESCAPE-NA1 Trial. American Journal of Neuroradiology, 42(8), 1375-1379.
4. GI-2 composite outcome measure – time taken to pass first stool and tolerate oral intake
5. electroCore Corporate Presentation November 2021