Type: Human monoclonal anti-GM-CSF antibody licensed by GSK from MorphoSys for all development and commercialization activities in all therapeutic fields.
2021 Status: GSK acknowledged February 25 that otilimab failed the primary endpoint of the 806-patient Phase II proof of concept OSCAR (Otilimab in Severe COVID-19 Related Disease) trial (NCT04376684), as the proportion of COVID-19 patients who were alive and free of respiratory failure 28 days after treatment with a single dose of otilimab plus standard of care, compared to patients being treated with standard of care alone did not reach statistically significance.
However, a pre-planned efficacy analysis of the study’s 180 patients 70 years and older showed that 65.1% of those patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 45.9% of patients who received the standard of care alone. Also, in an analysis up to day 60, a treatment difference favoring otilimab was seen with mortality rates of 40.4% on standard of care vs. 26% on otilimab plus standard of care in patients 70 years and older.
GSK said it will amend OSCAR to to confirm those findings with an additional cohort that will follow a similar study design and will enroll approximately 350 patients aged 70 years and older.
2020 Status: GSK on May 6 disclosed plans for a Phase II multi-center, double-blind, randomized, placebo-controlled trial (NCT04376684) designed to assess the efficacy and safety of otilimab for the treatment of severe COVID-19-related pulmonary disease.
The study population, estimated at 800 participants, will consist of hospitalized participants with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation less than or equal to 48 hours before dosing. Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care, GSK said. The trial’s estimated start date is May 18, and the estimated primary completion date is December 20.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: