US-based biopharmaceutical firm Ampio Pharmaceuticals has completed its Phase I clinical trial of intravenous (IV) Ampion treatment, which demonstrated safety in Covid-19 patients.
In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, linked with Covid-19.
Ampio noted that IV Ampion targets systemic inflammation in the body due to Covid-19.
The randomised, controlled Phase I study was conducted on adults hospitalised with severe Covid-19, who received either IV Ampion plus standard of care (SOC) or SOC alone.
After five-day treatment with Ampion, the study’s primary endpoint was analysed and safety was followed for an additional three months.
On reviewing the trial data, the Safety Monitoring Committee (SMC) found that the IV treatment of Ampion was safe and well-tolerated for 90 days following the therapy.
The study met its primary safety endpoint after five days of treatment and again after three months.
No major safety differences between Ampion treatment and SOC control arms were noted.
In addition, promising efficacy with Ampion was noted with the treatment group showing stronger clinical improvement over the SOC group.
Furthermore, Ampion-treated patients demonstrated greater improvement versus SOC group, including anti-viral therapies.
Ampio also began the initial steps for a global Phase II clinical trial of the therapy with two treatment groups while it builds on the safety profile from the Phase I study.
Clinical sites in Israel will be used in parallel with sites in the US for the study.
Apart from IV Ampion clinical programme, inhaled Ampion which targets localised inflammation in the lungs is also being analysed.
In September, Ampio completed enrolment for its Phase I clinical trial of Ampion intravenous treatment for Covid-19 patients who need supplemental oxygen.