Ampio's presentation is based on the Company's analysis that Ampio's drug candidate, Ampion™, currently under clinical investigation for the treatment of osteoarthritis and the hyper-inflammation observed with severe COVID-19, inhibits pro-inflammatory cytokine release, also known as the cytokine storm.
The presentation will summarize evidence that treatment utilizing Ampion suppresses Toll Like Receptor 7/8 (TLR7/8) signaling in monocytic/macrophage lineages and suggests a role for Ampion in treating the dysregulation of these pathways observed in lupus nephritis as well as in COVID-19. Toll Like Receptors are fundamental, innate mechanisms to detect and respond to pathogens (pathogen-associated molecular patterns, PAMPs, including viruses such as SARS-Cov2) or damaged cells (damage-associated molecular patterns, DAMPs) by activating a proinflammatory cascade in immune cells. Such dysregulated hyperactivation of these pathways is associated with the cytokine/chemokine storm observed in severe COVID-19 patients.
Ampio recently announced early positive data in its AP-014 Phase I clinical trial, utilizing Ampion in treating respiratory distress in patients as a result of COVID-19. The study showed inhaled Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) alone.
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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 using 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.