– Company in ongoing discussions with a major academic research center for design and execution of proof-of-concept study evaluating ADAIR for the treatment of cognitive impairment associated with COVID-19
PHILADELPHIA, PA, Feb. 28, 2022 (GLOBE NEWSWIRE) — Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued patent No. 11,253,490 covering the use of its proprietary investigational abuse-deterrent formulation of dextroamphetamine, ADAIR, for the treatment of cognitive impairment (sometimes referred to as “COVID brain fog”) associated with COVID-19.
The new U.S. patent covers a method of use for ADAIR for treating or alleviating symptoms of cognitive impairment in patients who have had a COVID-19 infection, with a base patent term extending until 2041.
David Baker, Chief Executive Officer of Vallon commented, “The medical community continues to gather data and learn about COVID-19 and the ways in which it manifests in patients. New research suggests that there may be long-term neurologic consequences in many patients who survive COVID infections, including cognitive impairment and attention issues. This symptom, sometimes referred to as ‘COVID brain fog,’ can have a significant impact on COVID-19 patients’ and survivors’ daily functioning and quality of life.”
Timothy Whitaker, M.D., Chief Medical Officer of Vallon added, “In light of the growing reports of patients experiencing cognitive impairment associated with COVID-19, and based on the data demonstrating dextroamphetamine’s ability to improve cognitive measures in patients with ADHD, we believe ADAIR has the potential to address/improve a number of these troubling symptoms/cognitive measures. We look forward to exploring this further.”
“COVID brain fog” refers to cognitive impairment experienced by patients who have recovered or are recovering from COVID-19. Symptoms of cognitive impairment include problems in concentration in studies and/or work; exhibiting reluctance or difficulty in acquiring new skills; finding multitasking jobs daunting; confusion; short-term memory loss; inability to give attention to a particular thing for a long time; slowness in completing usual tasks; difficulty in recalling a conversation or finding the right word to form a sentence; forgetfulness with image or list of words; and fatigue, mild depression, or anxiety. A recent study of 740 people (with an average age of 49) with no prior history of memory problems showed that patients treated for COVID-19 still had high rates of these symptoms an average of more than 7 months after diagnosis1. Results from another recently published study found that difficulties in attention, multitasking, and processing speed were common in hospitalized patients recovering from COVID-19 and of the patients in the study, 81% exhibited some degree of cognitive impairment2.
Based on ADAIR’s potential ability to improve cognitive measures, Vallon is in discussions with a major academic research center regarding the design and execution of a proof-of-concept study to evaluate ADAIR in recovering COVID-19 patients who are experiencing cognitive impairment or “brain fog” symptoms.
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Dextroamphetamine has been used clinically for more than 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the U.S. Food and Drug Administration (“FDA”).
About Vallon Pharmaceuticals, Inc.
Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The Company is focused on the development of new medications to help patients with CNS disorders. The Company’s lead investigational product candidate, ADAIR, is a novel abuse-deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.
References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.
Forward Looking Statements
This press release contains “forward-looking statements” that are based on Vallon’s current expectations and subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation, Vallon’s ability to execute its business plan, continue its growth and fund its ongoing business activities as planned, Vallon’s ability to develop and commercialize its product candidates, Vallon’s expectations related to results of clinical trials and studies, Vallon’s expectations with respect to the important advantages it believes its abuse-deterrent formulation of drugs have over similar drugs in the market and the growing need for abuse-deterrent formulations of drugs, Vallon’s ability to utilize the 505(b)(2) regulatory pathway, Vallon’s ability to obtain FDA approval of ADAIR and its other product candidates, the ability of ADAIR to treat cognitive impairment associated with COVID-19, Vallon’s ability to design and execute a proof-of-concept study to evaluate ADAIR in recovering COVID-19 patients who are experiencing cognitive impairment or “brain fog” symptoms, and Vallon’s expectations with respect to its cash runway. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Vallon’s Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
JTC Team, LLC
1 JAMA Netw Open. 2021;4(10):e2130645. doi:10.1001/jamanetworkopen.2021.30645, Assessment of Cognitive Function in Patients After COVID-19 Infection, Jacqueline H. Becker, PhD; Jenny J. Lin, MD, MPH; Molly Doernberg, MPH; et al
2 Neuropsychopharmacology, Frequency and profile of objective cognitive deficits in hospitalized patients recovering from COVID-19, Davis et al., 2020 medRxIV, Jaywant et al., 2021