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AMPE

Ampio

$0.44 /

-0.0073 (-1.63%)

07:08
03/24/20
03/24
07:08
03/24/20
07:08

Ampio suspends patient enrollment in Phase 3 clinical trial of Ampion

Ampio announced that it has suspended patient enrollment in its Phase 3 clinical trial of Ampion for the treatment of severe osteoarthritis of the knee. The trial focuses on individuals with the most severely diseased OAK, which represents an underserved patient population typically excluded from clinical studies because of the intractable nature of their condition. The average and maximum age of a patient in the AP-013 clinical trial is 65 and 87 years old, respectively. The Centers for Disease Control and Prevention have indicated that older adults, 65 years and older, are at higher risk for severe illness during the current COVID-19 pandemic. The Safety Monitoring Committee for the AP-013 clinical trial has unanimously recommended, following an interim analysis and due to extenuating circumstances relating to the COVID-19 virus, to minimize risk to study participants that, "The study cease enrolling patients because the number of injected patients, 1,019, is sufficiently close to the number of patients called for by the sample size re-estimation algorithm, 1,034."The FDA has recognized that challenges may arise, for example, from quarantines, site closures, travel limitations, and/or other considerations due to the pandemic. The Contract Research Organization running the AP-013 clinical trial for the company has notified the company that due to the COVID-19 virus, all travel has been suspended for clinical study monitors, which severely limits our ability to monitor the conduct of the AP-013 clinical trial. Recognizing these challenges, the Company is exploring options to enable it to complete the trial but notes that it is possible that the COVID-19 pandemic may prevent completion of the AP-013 trial at this time or at all. Concurrently, the company is focusing on investigating the potential use of nebulized Ampion for the treatment of a serious complication of COVID-19, the rapid onset of respiratory failure, termed Acute Respiratory Distress Syndrome. Based on Ampion's immunomodulatory and anti-inflammatory action, we believe that it may help individuals with widespread inflammation in the lungs and may reduce this serious complication of COVID-19.

AMPE Ampio
$0.44 /

-0.0073 (-1.63%)

12/18/19 Roth Capital
Ampio initiated with a Buy at Roth Capital

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