Ampio Pharmaceuticals Inc., the U.S-based biopharmaceutical firm focused on the development of novel therapies aimed at treating common inflammatory conditions, has reportedly commenced recruiting and enrolling patients in Phase I randomized, multi-center, and controlled clinical trial for 40 patients that will evaluate the efficacy and safety of inhaled ‘Ampion’ drug added to the SOC (standard of care) for SARC-COV-2 infected patients hospitalized for respiratory distress.

Sources cite that the clinical trial will register 40 patients, randomized 1 to 1, for the evaluation of Ampion in addition to SOC against SOC alone. Every patient will inhale 8 mL Ampion doses four times a day for five consecutive days. Safety is the primary end-point of this clinical trial while numerous measurements indicative of efficacy are secondary endpoints.

All COVID-19 patients will take Ampion through the inhalation process, allowing the drug to directly aim and weaken inflammation in the lungs. The drug will be administrated by either a hand-held nebulizer for patients with mild to moderate COVID-19 symptoms or by mechanical ventilation (intubation) and non-invasive ventilation (face mask) in patients infected with more severe disease.

The first three COVID-19 patients inhaling Ampion will be evaluated by a Safety Monitoring Committee for an extra three days after the five day treatment period, as compulsory by the protocol, as inhalation is a novel method of Ampion administration permitted for clinical use by the US FDA.

For the record, Ampio Pharmaceuticals is a development stage biopharmaceutical firm mainly focused on the development of Ampion for the treatment of prevalent inflammatory conditions for which there are restricted treatment options.

The company’s lead drug, Ampion, is supported by  numerous patents with intellectual property protection extending till 2032. The drug will be eligible for twelve year US FDA market exclusivity upon authorization as a novel biologic under the BPCIA (Biologics Price Competition and Innovation Act).

Source credit - https://ampiopharma.com/news/ampio-begins-phase-1-clinical-trial-of-inhaled-ampion-for-covid-19-patients-with-respiratory-distress/