US-based biopharmaceutical firm Ampio Pharmaceuticals has completed enrolment for its Phase I clinical trial of Ampion intravenous treatment for Covid-19 patients who need supplemental oxygen.
The safety monitoring committee (SMC) and the principal investigator are expected to complete their review this week. Based on the review findings, the company will report the final data from the five-day treatment regimen.
Ampion is the company’s lead product candidate being developed to treat prevalent inflammatory conditions with limited therapy options.
The company started patient enrolment and dosing in the Phase I Covid-19 trial in July. The primary endpoint is the safety and tolerability of IV Ampion treatment in adult patients.
Ampion is expected to hinder the inflammatory cascade caused by Covid-19 infection and improve the clinical course and outcome of patients.
Trial principal investigator Dr Michael Roshon said: “Our understanding of Covid-19 continues to evolve and we are pleased to partner with Ampio in this trial to assess Ampion’s potential as a treatment in the fight against Covid-19.
“It is clear that modulation of the immune response to Covid-19 is one of the most promising therapeutic targets. We are very interested in investigating Ampion’s effect on inflammation in this setting.”
The drug candidate is also being evaluated in a Phase III study of an intra-articular formulation for the treatment of severe osteoarthritis of the knee (OAK).
This Phase III study was paused in April 2020 over logistical issues related to the Covid-19 pandemic.
In compliance with the US Food and Drug Administration (FDA) guidance, the company remains blinded to the data captured before pausing the trial.
The company anticipates enough objective information to support the submission of its proposal to the FDA. The aim is to complete and send the proposal to the FDA in the fourth quarter of this year.