Adamis Pharmaceuticals Provides Enrollment Update of Subjects in Phase 2/3 Study of Tempol for the Treatment of COVID-19
Adamis Pharmaceuticals Corporation recently announced the enrollment and dosing of more than 100 subjects in the Company’s ongoing Phase 2/3 study of Tempol for the treatment of COVID-19. The Data Safety Monitoring Board (DSMB) will now examine clinical and safety data from the first 50 subjects as part of the first interim analysis.
COVID-19 is a complex disease that manifests in multiple phases including, among others, viral replication and hyperinflammation. Preclinical studies of Tempol have shown it to have antiviral, anti-inflammatory, and antioxidant activity. The company believes this unique mechanism of action, combined with the benign safety profile shown in preclinical and ongoing clinical studies, could provide physicians with a tool to intervene to slow or stop progression of COVID-19 at multiple phases of the disease. If proven, this could provide Tempol with a significant advantage over the two oral antiviral drugs that the FDA has recently granted Emergency Use Authorization (one having a mutagenesis issue and the other having been shown to have drug-drug interaction problems).
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, said “We are pleased with the rapid speed at which the trial is currently enrolling. The DSMB will now have the task of evaluating the preliminary data. If deemed acceptable, without safety or clinical issues, the trial will continue. The trial is designed to enroll a total of 248 patients. We have also recently applied for FAST Track designation, which, if granted, will allow for the rapid regulatory filing for this trial, if successful. Enrollment in this trial has recently dramatically increased and will likely continue to do so as patients with COVID-19 have limited treatment options, especially with Omicron and future variants arising. We believe that Tempol would fulfill a significant unmet medical need because of its antiviral and anti-inflammatory mechanisms of action. We intend to provide an update on the DSMB review of the interim analysis as the data is verified and statistical programs are validated. We estimate the meeting will convene in March.”
Recently, researchers from the National Institutes of Health (NIH) highlighted Tempol as a potential home antiviral treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19).
The company also recently announced (https://ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-announces-publication-human-immune) the results of a published study in collaboration with Stanford University researchers suggesting that Tempol has strong, broad in-vitro anti-cytokine activity. Suppression of inflammatory cytokines with an antioxidant may be a beneficial treatment strategy in COVID-19 infection.
Additional information about the trial can be found on www.clinicaltrials.gov using the identifier NCT04729595.
Adamis has licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19, and for the reduction of radiation-induced dermatitis in patients undergoing treatment for cancer.
Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions, and the request can be initiated by the drug company at any time during the development process. FDA will review the request and decide based on whether the drug fills an unmet medical need in a serious condition. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process.
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The company’s SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The company’s ZIMHI (naloxone) Injection product is approved for the treatment of opioid overdose (https://www.zimhi.com/). Tempol is in development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For additional information, visit www.adamispharmaceuticals.com.
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