Cerecor has announced positive results from its exploratory Phase II US-based proof of concept trial of a monoclonal antibody, CERC-002, in patients hospitalised with Covid-19 related pneumonia and mild-to-moderate acute respiratory distress syndrome (ARDS).
Licensed from Kyowa Kirin, CERC-002 is a human anti-LIGHT or tumour necrosis factor superfamily member 14 (TNFSF14) monoclonal antibody.
The randomised, double-blind, placebo-controlled trial enrolled 83 patients who were randomly given either a single 1,200mg dose of CERC-002 or placebo subcutaneously, along with the standard of care.
The trial’s primary endpoint was analysing number of participants alive and free of respiratory failure over the trial period of 28 days.
Data showed that Covid-19 ARDS patients who received CERC-002 showed robust improvement in the primary endpoint versus placebo.
In addition, the analysis showed that a prespecified subgroup of patients aged 60 years who were given CERC-002 had more than a three-fold increase in the chances of avoiding respiratory failure and death versus placebo.
An approximately 50% decrease in 28-day mortality in the treatment group was also noted as compared to placebo.
As of 31 December 2020, Covid-19 related deaths in patients receiving CERC-002 versus placebo were four and nine, respectively.
Cerecor chief medical officer Jeff Wilkins said: “We are very excited about these results as they demonstrate the therapeutic potential of CERC-002.
“In spite of recent advances in the treatment of Covid-19 ARDS patients, Covid-19 remains a global health threat, and this study demonstrates the potential for significant improvement for patients most at risk.”
The therapy was observed to be well-tolerated with no drug-related SAEs noted.
Furthermore, the antibody treatment demonstrated activity on top of corticosteroids in Covid-19 ARDS.
Cerecor chief scientific officer Garry Neil said: “The data from this proof-of-concept study clearly demonstrate that neutralizing LIGHT with CERC-002 can improve clinical outcomes for Covid-19 ARDS patients, even when given to patients on concomitant steroids and remdesivir.”