Adamis Pharmaceuticals Announces Pre-IND Feedback from FDA Enabling Advancement of Tempol, a Novel Anti-Inflammatory and Anti-Oxidant Drug for the Treatment of COVID-19
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has received positive feedback from the FDA regarding its Pre-IND filing for Tempol, a potential treatment for COVID-19. The FDA's comments enable Adamis to formally submit an IND application and seek government funding for clinical trials and manufacturing. CEO Dr. Dennis Carlo emphasized Tempol's promising capabilities to prevent disease progression by counteracting the cytokine storm associated with COVID-19. The company is also developing products for various acute respiratory diseases, including ZIMHI, which is under FDA review.
- FDA's positive feedback allows Adamis to move forward with Tempol's IND submission.
- Potential funding opportunities for clinical trials and manufacturing of Tempol.
- Tempol is positioned as a candidate to treat COVID-19 by inhibiting cytokine storms.
- No guarantees regarding the safety and effectiveness of Tempol.
- Funding needs remain uncertain, with no assurance of availability.
SAN DIEGO, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today that in response to Adamis’ Pre-Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled trial. The FDA’s response now allows Adamis to proceed to the next step of formally submitting an IND for Tempol, and at the same time, begin formal applications for funding to governmental agencies to support the clinical trial and large-scale manufacturing.
Dr. Dennis J. Carlo, President and CEO of Adamis stated: “After submitting an extensive clinical protocol entitled ‘Preventing COVID-19 Related Hospitalizations in Subjects with COVID-19 Infection’, we received thoughtful and comprehensive guidance from the FDA. We believe that Tempol’s unique antioxidant and anti-inflammatory activity, and its ability to inhibit the “cytokine storm” in pertinent animal models, makes it a strong candidate for the potential treatment of COVID-19. By protecting healthy cells, Tempol may delay or prevent disease progression and hospitialization.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, 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. Adamis’ naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose is currently under FDA review with a target action date of November 15, 2020. In May 2020, the Company announced a partnership with US WorldMeds for the commercialization of SYMJEPI and, if approved by the FDA, ZIMHI. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19, influenza, asthma and COPD. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, and surgery centers throughout most of the United States.
Adamis Forward Looking Statements
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, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the safety and effectiveness of the compounds or product candidates described in the press release; the timing of commencement of completion of any clinical trials relating to Tempol; the results of any future clinical trials that the company or may conduct relating to Tempol; the company’s ability to apply and obtain government or other funding for clinical trials relating to Tempol or the timing or amount of any such funding; the company’s ability to commercialize the product candidates described in this press release, itself or through commercialization partners; and other statements concerning our future operations and activities. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are only predictions, are not guarantees, involve known and unknown risks, uncertainties and other factors, and concern matters that could subsequently differ materially from those described in this press release, which may cause Adamis' actual results to be materially different from those contemplated by these forward-looking statements. There can be no assurances regarding the timing or outcome of our submission of an IND relating to a clinical trial for Tempol, regarding the timing or the outcome of our applications for government or other funding for clinical trials relating to Tempol; concerning the timing or outcome of any such clinical trials; 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 concerning our anticipated future activities assume that we are able to obtain sufficient funding to support such activities and continue our operations and planned activities. As discussed in our filings with the Securities and Exchange Commission, we will require additional funding, and there are no assurances that such funding will be available if required. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks, and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2019, and our subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.
Contacts:
Mark Flather
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation
(858) 412-7951
mflather@adamispharma.com
FAQ
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