March 2021 – CROss Alliance® is excited to share the news that on March 1st the first healthy volunteer in the Phase I clinical trial with the anti SARS-COV2 monoclonal antibody MAD0004J08 has been treated
MAD0004J08 has been discovered by Toscana Life Sciences Foundation and developed by Toscana Life Sciences Sviluppo (TLS-S) and is aimed to be a therapeutic tool for SARS-CoV-2. Management of the Phase I clinical trial has been assigned to CROSS Research who has very closely collaborated with TLS in the last few months to obtain the regulatory approval in a race against time and pandemic rise.
The Spallanzani Institute in Rome (IT) and the Clinical Research Centre in Verona (IT) will enrol 30 healthy adult men and women overall. This phase I study aims to ascertain the safety of the monoclonal antibody, defined as absence of serious adverse events after treatment of the healthy volunteers participating in the study. Furthermore the study will describe the pharmacokinetics of the molecule.
The study participants will be divided in three cohorts and will receive one of three ascending doses of MAD0004J08 or placebo according to a randomised placebo controlled trial design.
MAD0004J08 is the fruitful result of MAD (Monoclonal Antibody Discovery) Lab research, coordinated by Dr. Rino Rappuoli at TLS Foundation.
The benefits expected from the treatment with MAD0004J08, as part of the entire clinical trial pathway, are the shortening of the time a COVID-19 patient is infectious and must remain quarantined, and a more benign clinical course of the disease. A shorter time to infection eradication would reduce the likelihood of spreading the infection. A shorter duration of the quarantine would have in many patients an important positive impact on income, family life and psychological wellbeing. A more benign course of COVID-19 would have medical, social and economic benefits for individual patients and society.
CROSS Research is honoured to participate in this clinical trial and to give its best contribute to the success of this promising drug against the pandemic that has dramatically influenced lives world-wild since December 2019.