Theravance is considering that the TD-0903 can block the cytokine storm linked with ALI and prevent progression to acute respiratory distress syndrome (ARDS).
According to the company, the TD-0903 has been demonstrated in experimental murine models to have potent and broad inhibition of JAK-STAT signalling in the airways following challenges with multiple cytokines.
The company initiated the phase 2 study in the UK following the successful completion of dosing in the phase 1 study in healthy volunteers at the same clinical unit in the country.
The phase 2 study includes two parts, of which the first one will evaluate the safety, tolerability and clinical response to treatment in sequential ascending dose cohorts of hospitalised Covid-19 patients.
Each patient will be dosed for seven days. The company will recruit the patients if they show hypoxia as it is expected to be a marker of underlying hyper inflammation (cytokine storm) in the lung.
The second part is said to be a larger and multi-centre study carried out at hospital-based clinical sites in the UK, as well as other European countries and in the US. It is subject to the appropriate Ethics Committee and regulatory approvals in those territories.
Theravance Biopharma CEO Rick Winningham said: “Working with the Medicines Evaluation Unit over the past few months has once again been an outstanding experience as we mobilized our response to Covid-19.
“The initiation of the Phase 2 study of TD-0903 is a significant milestone in our ongoing efforts to apply our organ-selective therapies and expertise to treat inflammatory conditions.”
In February 2018, Janssen Biotech announced that it will co-develop Theravance’s TD-1473 and associated backup compounds for inflammatory intestinal diseases, including ulcerative colitis and Crohn’s disease, through an agreement that is potentially worth about $1bn.