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Nēsos receives FDA Breakthrough Device Designation for its disease-modifying digital therapeutic for Rheumatoid Arthritis

Nēsos, the company developing disease-modifying digital therapeutics for inflammation-mediated disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its digital therapeutic for patients with rheumatoid arthritis (RA) who have had an inadequate response or intolerance to disease-modifying anti-rheumatic drugs (DMARDs). The company, supported by a strong investor group that includes Mayfield Fund, DigiTx Partners, and new investors Astellas Rx+ Business Accelerator, LLC, and Amazon Alexa Fund, has initiated the next phase of clinical testing of its prescription rheumatoid arthritis asset towards an FDA approval. Additionally, Nēsos is advancing the clinical development of its neurological and mental health assets.

The Breakthrough Devices Program was launched by the FDA to give patients and health care providers faster access to medical devices that have the potential to provide more effective treatment over existing approved products for life-threatening or irreversibly debilitating diseases. “The interactive communication with the FDA and the priority regulatory review enabled under the Breakthrough designation fast track framework would be key in expediting time to market,” said Konstantinos Alataris, Ph.D., President and CEO of Nēsos. “Additionally, the Breakthrough designation can help facilitate reimbursement support and enhance patient access following an FDA approval”

There are more than 2 million Americans diagnosed with RA. Despite the available pharmaceutical options, many patients either do not respond, lose therapeutic response or are intolerant to these medications. The Nēsos digital therapeutic, developed on its ē-mmunotherapy platform, utilizes engineered electrical pulse sequences delivered by purpose-built earbuds, to modulate the central nervous system (CNS) pathway that helps control immune response. Rheumatoid arthritis patients, enrolled in a proof-of-principle study published in Lancet, Rheumatology, had a sustainable and clinically meaningful improvement. If this initial clinical experience is validated in the required further clinical testing, the Nēsos digital therapeutic can potentially provide a new treatment option with top-of-the-line efficacy and a significantly improved safety profile.

Learn more at Nesos.com.

The interactive communication with the FDA and the priority regulatory review enabled under the Breakthrough designation fast track framework would be key in expediting time to market,” said Konstantinos Alataris, Ph.D., President and CEO of Nēsos. “Additionally, the Breakthrough designation can help facilitate reimbursement support and enhance patient access following an FDA approval.”

ABOUT NĒSOS:

Nēsos aims to treat diseases, by modulating central nervous system (CNS) pathways that control immune function. Using engineered electrical signals delivered by a noninvasive brain interface. Nēsos is guided and supported by clinical and scientific collaborators from top academic institutions, including Stanford, Vall d’Hebron, Harvard, Mount Sinai, Feinstein Institute, University of California, San Diego, and the University of California, San Francisco. For more information, visit www.nesos.com.

( Press Release Image: https://photos.webwire.com/prmedia/42381/273007/273007-1.jpg )

 The Lancet Rheumatology Publishes pilot clinical data showing promising efficacy and safety profile for e-mmunotherapy in Rheumatoid Arthritis patients.

Fifty-three percent (53%) of patients receiving e-mmunotherapy, using the Nēsos earbud shaped neural interface, had meaningful reduction in disease activity after 3 months, while 37% of patients achieved low disease activity and 23% of patients achieved remission.

REDWOOD CITY, Calif., February 2, 2021– The Lancet Rheumatology published data from a pilot clinical study evaluating the Nēsos developed e-mmunotherapy treatment, in a cohort of rheumatoid arthritis patients. Patients with moderately to severely active rheumatoid arthritis
(RA) despite treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) received daily e-mmunotherapy. E-mmunotherapy provides engineered neural input, electrical pulse sequences delivered from purpose designed earbuds, to activate the cholinergic anti-inflammatory pathway.

The study demonstrated a meaningful reduction in the signs of symptoms of RA in 53% of the treated patients after 3 months based on the American College of Rheumatology (ACR) response criteria (ACR20). In addition, 37% of patients achieved low disease activity, while 23% achieved remission (as defined by the disease activity score cutoffs of DAS28-CRP < or equal to 3.2 and DAS28-CRP < 2.6 respectively). Significant improvement in patient reported outcomes suggest that the device might help address key unmet needs for patients with rheumatoid arthritis, such as those concerning pain and sleep. Almost two-thirds of patients saw improvements in their ability to fall asleep at night, and 70% of patients had a reduction in the number of times pain woke them up at night.

“If this data is validated in further clinical testing, e-mmunotherapy can provide a viable new therapeutic option for rheumatoid arthritis patients. The potential for meaningful clinical benefit plus an improved side effect profile, compared to biologic therapies like TNF-alpha
inhibitors or synthetic DMARDs like JAK inhibitors, drive future development efforts” said Professor Sara Marsal MD, University Hospital Vall d’Hebron, Barcelona, Spain and principal investigator in this first human multicenter study.

Eighty-five percent (85%) reported they were either satisfied or very satisfied with using the device and nine three percent (93%) of patients reported that they saw some level of improvement in activity, symptoms, emotions, and overall quality of life. There was one devicerelated adverse event, a superficial skin abrasion at the site where the earpiece contacted the ear, that resolved without intervention.

“We are very excited by the data thus far and think this approach could provide real benefit for patients in the future” added Dr. Matthew Baker MD Clinical Chief, Division of Immunology and Rheumatology, Stanford University and an advisor to Nēsos. “The overwhelmingly positive feedback we have received from patients has been great to see. We look forward to taking the next steps in further understanding the potential this device has to offer. “

Based on the results of this pilot study Nēsos has initiated a double blinded, randomized, sham-controlled trial to be conducted at multiple study sites in the United States.

Full results published in The Lancet Rheumatology available online:
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30425-2

About Nēsos
Leveraging neuroscience research, Nēsos aims to treat diseases, by restoring neurological pathways that control immune function. Neuroplasticity altering electrical fields, delivered by a noninvasive brain interface, are used to activate target brain pathways. Nēsos is guided and supported by clinical and scientific collaborators from top academic institutions, including Stanford, Vall d’Hebron, Harvard, Mount Sinai, Feinstein Institute, University of California, San Diego, and University of California, San Francisco. For more information, visit www.nesos.com .

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