Tempol clinical trial has reached planned initial enrollment of 248 subjects
Independent Data Monitoring Board to review interim data from approximately 200 initial subjects
SAN DIEGO, Sept. 12, 2022 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that the company’s ongoing U.S. Phase 2/3 clinical trial to assess the safety and efficacy of Tempol as a treatment for COVID-19 has reached the planned initial enrollment of 248 subjects.
“We are very pleased to have achieved this milestone in the trial and look forward to the next DSMB meeting later this month,” said David J. Marguglio, CEO of Adamis. “This interim meeting is significant because it will mark the first time the DSMB has evaluated statistical measures of effectiveness for Tempol.”
The Data Safety Monitoring Board (DSMB) is made up of infectious disease experts who independently review data from unblinded trials and make recommendations. The DSMB previously met to assess the clinical and safety data from the interim analyzes in March and June 2022, and both times recommended that the study continue without modification. At the September meeting, the DSMB plans to assess the primary efficacy endpoint, sustained resolution of COVID-19 symptoms, as well as safety in individuals at high risk of disease progression for about 190 subjects.
If analysis of interim clinical data has shown significant efficacy, the DSMB may recommend stopping the trial as it has already demonstrated statistical significance. If the interim data indicated no efficacy on the primary endpoint, the DSMB would likely recommend stopping the trial for futility. Depending on this result, the company would begin to analyze the then unblinded data to determine if there was efficacy on the secondary endpoints. If positive efficacy trends are observed on the primary endpoint in favor of Tempol, but statistical significance is not reached, the DSMB may recommend continuing the trial and enrolling additional patients to further fuel the study.
Ron Moss, MD, Chief Medical Officer of Adamis added, “If interim data or final clinical data show positive results, we will submit a clinical study report to the FDA and request a meeting to discuss the results and emergency potential. Use authorization. The Agency has approved two oral antivirals under the EUA for outpatients with COVID-19. Whatever form COVID-19 takes in the future, we believe there will always be a medical need and a large market for effective new therapies.
About the trial
“A Phase 2/3, adaptive, randomized, double-blind, placebo-controlled study to examine the effects of Tempol (MBM-02) in subjects with COVID-19 infection” was designed to enroll approximately 248 high-risk subjects with early COVID -19 age of infection 18 years and older. The primary endpoint is the rate of sustained clinical resolution between Tempol and standard therapy versus placebo and standard therapy at day 14. In addition to the primary endpoint, a number of secondary endpoints will be examined, including but not limited to changes in inflammatory markers, hospitalizations, and all cause mortality. Eligible subjects with positive COVID-19 infection within five days of study entry plus at least one comorbidity were randomized one-to-one to receive Tempol or placebo. Comorbidities include age 65 or older, hypertension, diabetes, obesity, cancer, immunodeficiency and, in the opinion of the investigator, the risk factor is not seriously life threatening in danger. Patients randomized to Tempol received 800 mg daily in two divided oral doses of 400 mg capsules for up to 21 days. Similarly, placebo capsules were administered twice daily to subjects in the placebo group for up to 21 days. Additional information about the trial can be found at www.clinicaltrials.gov using the identifier NCT04729595.
Tempol is a redox cycle nitroxide that promotes the metabolism of many reactive oxygen species and improves the bioavailability of nitric oxide. It has been widely studied in animal models of oxidative stress and inflammation. Preclinical studies of Tempol have shown it to have anti-inflammatory and antioxidant activity. Adamis has licensed exclusive rights to certain patents, patent applications and related know-how relating to Tempol for certain licensed areas, including the areas of COVID-19 infection, asthma, infection by respiratory syncytial virus and influenza infection, as well as radiation treatment – induced dermatitis.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on the development and commercialization of products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory diseases. The company’s SYMJEPI ® (epinephrine) Injectable products are FDA approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The company’s ZIMHI ® (naloxone) The injectable product is approved for the treatment of opioid overdoses. Tempol is being developed for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For more information about Adamis Pharmaceuticals, please visit our website and follow us on Twitter and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipations, intentions, contingencies, objectives, targets or future developments and /or are not otherwise statements of historical fact. These statements relate to future events or future operating results, including, but not limited to, the following statements: statements regarding the Company’s Phase 2/3 clinical trial for Tempol; statements regarding the activities and process of the DSMB and the timing and outcome of that process; the Company’s beliefs regarding the mechanisms of action, safety and efficacy of Tempol and that Tempol fulfills an unmet medical need; the timing, progress or results of the Company’s Phase 2/3 clinical trial for Tempol or other studies or trials relating to Tempol; the Company’s beliefs regarding the ability of its products and product candidates to be competitive in the marketplace; the Company’s beliefs regarding the benefits, applicability and extent of intellectual property rights and protection afforded by patents and patent applications it owns or has licensed, including those relating to Tempol ; the Company’s ability to successfully commercialize the products and product candidates, either itself or through commercialization partners; and other statements regarding the future operations and activities of the Company. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis’ actual results to differ materially from the results anticipated by such forward-looking statements. There is no assurance regarding the timing or outcome of, or recommendations resulting from, any future meeting of the DSMB. There can be no guarantees regarding the timing, progress or results of any trials or studies relating to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. In addition, forward-looking statements regarding our planned future activities assume that we have sufficient funding to support those activities and continue our planned operations and activities. Statements in this press release regarding future events are dependent on several factors beyond the Company’s control, including the absence of unexpected developments or delays, market conditions, the availability of sufficient funding and the process regulatory approval. We cannot assess the impact of each factor on our business or the extent to which any one factor, or combination of factors, could cause actual results to differ materially from those contained in the forward-looking statements. You should not place undue reliance on forward-looking statements. Further, any forward-looking statement speaks only as of the date the statement is made, and except as required by applicable law, we undertake no obligation to update or publicly release the results of any revisions to such statements. forward-looking statements or to reflect events or circumstances occurring after the date of this press release. Certain of these risks and additional risks, uncertainties and other factors are more fully described in Adamis’ periodic filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and the following years. SEC filings, which Adamis urges you to read and consider, all of which are available free of charge on the SEC’s website at http://www.sec.gov.
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