View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
March 29, 2022

Capricor reports topline data from Phase II trial of Covid-19 cell therapy

In the trial, single dose of CAP-1002 was demonstrated to be safe, well-tolerated.

Capricor Therapeutics has reported topline data from the Phase II INSPIRE trial of its single-dose cell therapy, CAP-1002, to potentially treat hospitalised patients with severe Covid-19.

CAP-1002 comprises allogeneic cardiosphere-derived cells (CDCs), a kind of progenitor cell.

The double-blind, randomised, placebo-controlled trial enrolled 63 severe to critical Covid-19 patients who needed supplemental oxygen. 

They were randomised into a 1:1 ratio to receive either CAP-1002 or placebo and underwent baseline safety and efficacy analyses until 90 days after infusion.

Carried out at various sites in the US, the trial assessed the safety of a single intravenous dose of CAP-1002 and various exploratory efficacy outcomes as the primary objective.

Capricor noted that the efficacy endpoints of the trial were exploratory as it was not intended to identify treatment differences. 

According to the findings, the trial of CAP-1002 in hospitalised Covid-19 patients met the primary objective of safety. 

In the trial, CAP-1002 was demonstrated to be safe, well-tolerated and in line with its previously reported safety profile.

Overall mortality was found to be 20%, with six and five deaths reported in the placebo arm and CAP-1002 arm, respectively.

Capricor CEO Linda Marbán said: “We were pleased that CAP-1002 was shown to be safe and well-tolerated in this group of patients that were profoundly ill with symptoms of Covid-19, which bodes well for the general safety and tolerability of infused CAP-1002 even in this heterogeneous and severely sick population of patients. 

“In light of the effectiveness and widespread use of available vaccines, the reduction in mortality and the decline in Covid-19 hospitalisation rates in the United States, we will continue to evaluate the next steps for this programme.”

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper

Secure the cell therapy supply chain from bench to bedside

The development of cell therapies is changing healthcare, delivering new hope to thousands of patients around the world. The vein-to-vein workflow for these therapies, however, is not without challenges, many of which will increase as we scale up to treat more patients. Download this free guide from Cytiva to learn more about the challenges and risks associated with the cryogenic supply chain for cell therapies, and how supply chain disruptions can best be mitigated.
by Cytiva Thematic

By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena