AMPE Ampio Pharmaceuticals Inc.

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Market Cap $166,849,844
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Enterprise Value $163,350,844
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Av. Daily Volume 4,567,767
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Drug Pipeline

Drug Stage Notes
IV Ampion
COVID-19
Phase 1
Phase 1
Phase 1 commencement of enrolment announced July 23, 2020.
Ampion
Osteoarthritis of the Knee
Phase 3
Phase 3
Phase 3 enrolment has been suspended - noted March 24, 2020.
Optina
Diabetic Macula Edema
Phase 2b
Phase 2b
Phase 2b data released May 2015 did not meet endpoints

Latest News

  1. ENGLEWOOD, Colo., Sept. 21, 2020 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE:AMPE) (the "Company") announces the receipt of an Investigational New Drug ("IND") from the U.S. Food and Drug Administration ("FDA"), allowing the Company to proceed with clinical trials for the use of AmpionTM as an inhalation therapy for respiratory distress due to COVID-19 infection.

    Expanding on the recently successful Phase I trial that administered Ampion intravenously to COVID-19 patients (https://ampiopharma.com/news/ampio-reports-positive-results-in-early-trial-for-iv-ampion-treatment-in-covid-19-patients/), the current Phase I trial of inhaled Ampion will be a multi-center, randomized, controlled trial for a total of 40 patients, and will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress. Ampion will be delivered by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs that can lead to respiratory failure. This approved clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the clinical progression of COVID-19 infection. Ampion will be delivered by a hand-held nebulizer for inhalation by patients with less severe cases of respiratory illness and through mechanical ventilators to those patients who have progressed to severe respiratory distress syndrome ("ARDS").

    The FDA relied on safety and efficacy data from comprehensive preclinical laboratory studies provided by Ampio to Grant this IND. Toxicology studies demonstrated that Ampion is safe for inhalation, and extensive laboratory data indicates that Ampion can effectively reduce signaling proteins responsible for tissue damage and pulmonary complications. These studies also revealed that Ampion can effectively increase signaling molecules required for tissue repair and healing in the lungs. Ampion's mechanism of action may interrupt the pulmonary disease process and provide much needed relief and recovery for patients suffering from shortness of breath and respiratory illness related to COVID-19 infection.

    The current IND along with Ampio's active INDs for the introduction of Ampion intravenously and by intraarticular injection builds upon Ampion's potential as a platform drug, treating multiple conditions characterized by inflammation.  A recurring theme across all clinical trials with Ampion is that this anti-inflammatory biologic has been safe and well-tolerated with no serious drug related adverse events.

    About Inflammatory Diseases

    Inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect. Inflammatory disorders that result in a dysregulated immune response by attacking the body's own cells or tissues may result in chronic pain, tissue damage and loss of function. Inflammation plays a major role in many disease processes including allergy, asthma, autoimmune disorders such as hepatitis, inflammatory bowel disease, transplant rejection and more.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "may," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, the timing and outcome of clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Daniel G. Stokely, CFO

    Phone: (720) 437-6500

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-grants-ind-and-approves-clinical-trial-protocol-of-inhaled-ampion-for-covid-19-patients-with-respiratory-distress-301134495.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  2. ENGLEWOOD, Colo., Sept. 14, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado, who served as Principal Investigator of the just completed Phase I trial of intravenous Ampion™ for treatment of COVID-19 patients, and David Bar-Or, MD, founder of Ampio Pharmaceuticals, were interviewed about those clinical results on a Colorado affiliate FOX news segment titled, "Colorado Drug shows promise against COVID-19", which can be viewed in its entirety at:

    ENGLEWOOD, Colo., Sept. 14, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado, who served as Principal Investigator of the just completed Phase I trial of intravenous Ampion™ for treatment of COVID-19 patients, and David Bar-Or, MD, founder of Ampio Pharmaceuticals, were interviewed about those clinical results on a Colorado affiliate FOX news segment titled, "Colorado Drug shows promise against COVID-19", which can be viewed in its entirety at:

    https://kdvr.com/video/colorado-drug-shows-promise-against-covid-19/5844056/

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").                                                        

    Forward-Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500

     

    Ampio Pharmaceuticals, Inc.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampion-phase-i-covid-19-patient-trial-results-featured-on-fox-news-video-301130079.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  3. ENGLEWOOD, Colo., Sept. 9, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced positive results in early trial for intravenous ("IV") AmpionTM treatment for COVID-19 patients. We believe Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome in patients treated with Ampion. 

    The Phase I trial was led by Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado. The trial was a randomized, controlled study of adults hospitalized, confirmed SARS-COV-2 ("COVID-19") positive by PCR test and receiving supplemental oxygen. Patients were randomized 1:1 to receive IV Ampion treatment or standard of care, including anti-viral therapies, such as Remdesivir or convalescent plasma, both approved by the FDA under emergency use authorization ("EUA") as standard of care.  The majority of the patients in the control group were prescribed Remdesivir anti-viral treatment while no patients in the IV Ampion group received that anti-viral therapy.

    The study met its primary endpoint for the safety and tolerability of IV Ampion treatment, with no remarkable difference in the incidence, frequency, and severity of adverse events between IV Ampion and standard of care.

    All patients treated with IV Ampion improved after treatment. At hospital discharge, the IV Ampion treatment group had a stronger clinical improvement than the COVID standard of care control group, as determined by both the World Health Organization ("WHO") clinical improvement scale1 and the National Early Warning Score ("NEWS2")2, which is recommended by the National Institute for Health and Care Excellence ("NICE") in its guidelines for the management of COVID-19 patients in critical care.

    Treatment options for COVID-19 are limited and the country continues to observe rising numbers of infection. These Phase I study results provide encouraging results that IV Ampion may be a safe and effective treatment for COVID-19 infected patients admitted to the hospital and needing supplemental oxygen.

    Patients will be followed over the upcoming months to complete the safety endpoint assessments for the Phase 1 clinical trial. Safety and efficacy results will be submitted to a peer-reviewed scientific journal and provide the basis for performing a Phase II/III trial with IV Ampion.

    1 WHO Clinical Improvement Scale: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf

    2 NEWS Critical Intervention Scale: https://www.mdcalc.com/national-early-warning-score-news-2

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "may," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that IV Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-reports-positive-results-for-ampion-treatment-in-covid-19-patients-301126438.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  4. ENGLEWOOD, Colo., Sept. 4, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions announces the following: 

    • Enrollment has been completed for the AmpionTM Phase I US based clinical trial for IV treatment of COVID-19 patients requiring supplemental oxygen. The final results from the 5-day treatment will be reported when the Safety Monitoring Committee ("SMC") and the Principal Investigator complete their evaluations which we expect should occur within the next week.
    • The current Ampion Phase III clinical trial ("AP-013") of an intra-articular injection of Ampion for treatment of severe OAK, was paused in April 2020 due to significant logistical issues associated with the COVID-19 pandemic. Recently, the FDA has provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. In order to remain in compliance with such guidance, we will continue to remain blinded to the trial results achieved prior to pausing the trial, however, we are confident there will be sufficient objective information to support the submission of our proposal to the FDA. Our plan is to have this proposal completed and sent to the FDA early in the 4th quarter 2020.

    About Ampio Pharmaceuticals 

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements  

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-announces-enrollment-completion-for-intravenous-iv-covid-19-clinical-trial--provides-update-on-osteoarthritis-of-the-knee-oak-clinical-trial-301124360.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  5. ENGLEWOOD, Colo., Aug. 19, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, provides updates regarding the following clinical trials:

    • Ampion Phase I clinical trial for intravenous ("IV") treatment of COVID-19 patients:

      The initial safety assessments are complete and the trial is cleared to enroll the remaining patients for the Phase I US based clinical trial evaluating a 5-day IV AmpionTM treatment for COVID-19 patients requiring supplemental oxygen. The results were reviewed by an independent Safety Monitoring Committee, comprised of four physicians, who found Ampion to be safe and well-tolerated, and who authorized the trial to move to completion. Additional details of the trial can be found on clinicaltrials.gov (NCT04456452).   
    • Ampion IND application for inhalation treatment of COVID-19 patients:

      The FDA requested comprehensive tests on the safety of nebulized Ampion at various doses. The results of these tests have been reviewed by independent toxicologists who found no evidence of toxicity in preclinical trials, even at extreme doses, and this extensive data has been submitted to the FDA. A clinical trial protocol for treating patients who have respiratory distress due to COVID-19 with nebulized Ampion has already been submitted and is being reviewed by the FDA. The addition of this safety data is expected to complete our IND application. 

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "may," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-provides-update-on-covid-19-clinical-trial-activities-301114581.html

    SOURCE Ampio Pharmaceuticals, Inc.

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