December 2021 – CROss Alliance® is glad to announce the completion of the clinical phase of CRO-20-144 trial with MAD0004J08, the monoclonal antibody developed by Fondazione Toscana Life Sciences (Italy) as a therapeutic agent against SARS-CoV-2 infection.
Thirty participants were enrolled in three different cohorts and received 3 ascending doses of the antibody at Centro Ricerche Cliniche Verona or at the Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” in Rome. The 30th and last healthy volunteer of the phase I trial completed the last study visit on 20th October.
Study data indicate an excellent tolerability and safety outcome (primary study objective). During the study the Data Monitoring Committee did not raise any concerns related to the antibody administration after each cohort completion. None of the subjects enrolled in the 3 cohorts had any serious adverse event in the first week after antibody intramuscular injection, nor during the six-month follow-up, when no SARS-CoV-2 infection was developed either.
Final analysis is underway: in addition to the excellent safety profile the analysis has confirmed promising efficacy data with very good serum neutralisation power versus wild type (WT) virus and viral variants of concern (i.e., alpha, beta, gamma and delta).
Final pharmacokinetic analysis is underway to describe the monoclonal antibody pharmacokinetic profile after one single intramuscular dose and confirm the expected long half-life which would allow the administration of a low dose maintaining at the same time a long-term action.
CROss Alliance® is grateful to have been involved in the project management, regulatory, monitoring, analytical, data management, statistical and reporting activities of this trial with high relevance for the social community and world health in this period of still relevant pandemic effects.
The company Toscana Life Sciences Sviluppo is the Sponsor of the study and is in charge of developing the therapy, currently in a phase II/III clinical trial.