Ampio Pharmaceuticals’ pipeline focuses on drugs with the potential to be safe and effective for human use.
New Uses for Previously Approved Drugs
Finding new medical uses (‘indications’) for previously approved drugs is an important strategy to accelerate development and improve success rates. Previously approved drugs have completed numerous safety tests and have established extensive human safety records. Clinical trials can often begin sooner, providing evidence that the drug works and reducing the risk of failure due to adverse human safety events. There are clear paths for regulatory approval in the U.S. (as a §505(b)(2) New Drug Application submission) and in the EU (under the “hybrid abridged” procedure).
New Molecular Entities (“NMEs”) – Drugs That Have Not Been Previously Approved
Ampio’s strategy for development focuses on NMEs that have the potential to be safest for human use. The company believes that drugs derived from naturally-occurring human proteins and peptides may have a higher chance of success in development due to their inherent human characteristics and activity.
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