Ampio Enters into Collaborative Research Agreements to Explore Additional Clinical Indications for its Immunomodulatory Drug, Ampion

Agreements made with the oldest and one of the top children’s hospitals in the United State

ENGLEWOOD, Colo., December  10, 2020 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that it has entered into two collaborative research agreements to explore new clinical indications for its immunomodulatory drug, AmpionTM.

Rare Inflammatory Pediatric Diseases

The Company entered into a collaborative research agreement with the oldest and one of the top children’s hospitals in the United States whereby both parties will work together and conduct exploratory research to determine whether the anti-inflammatory and signaling pathways of Ampion could play a role in the treatment of certain rare Inflammatory Pediatric Diseases.

Currently in clinical trials for treatment of inflammation due to osteoarthritis and COVID-19 related acute respiratory distress syndrome (ARDS), Ampion has been shown to reduce inflammation through multiple pathways. The exploratory research conducted under the collaborative research agreement will utilize cell culture models and proteomic, metabolomic, genomic and in silico computational methods as well as in vitro characterization of identified dysregulated signaling pathways in human cultured cell types (e.g. human epithelial cells, microvascular endothelial cells, peripheral blood mononuclear cells (PBMC)).

Inflammatory Kidney Disease Research

The immunology based anti-inflammatory properties of Ampion will be investigated as a treatment for acute and chronic kidney disease, extremely common conditions for which new therapies are needed. Ampion’s anti-inflammatory effects in acute kidney injury (AKI) and chronic kidney disease (CKD) is based on more than a dozen peer-reviewed publications that reported Ampion modulates anti-inflammatory signaling pathways known to be relevant in kidney disease. The FDA has approved three different methods of administration of Ampion: by direct intra articular injection, intravenous administration and by inhalation in the course of clinical trials for the treatment of ARDS in COVID-19 patients, COVID-19 patients requiring supplemental oxygen, and osteoarthritis of the knee. There have been no drug-related adverse events reported with any method of administration in any Ampion clinical trials.

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 United States Private Securities Litigation Reform Act of 1995, as amended to date. 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 the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio’s ability to continue as a going concern and its ability to continue to raise funds using its “at-the-market” equity offering or otherwise, 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, in Ampio’s Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

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