BI initiates Phase II testing of COVID-19 drug
Boehringer Ingelheim announced the start of Phase II studies of its oral TRPC6 blocker code-named BI 764198 in patients hospitalised for COVID-19.
A new potential weapon against severe complications such as ARDS caused by the new coronavirus SARS-CoV-2 have been advanced by Boehringer Ingelheim to Phase II stage after Phase I tests in man (NCT03854552) pointed to a therapeutic window. The oral drug candidate, BI 764198, is Boehringer Ingelheims second TRPC6 inhibitor. Positive results from the very first bioavailable oral TRPC6 inhibitor coded-named BI 749327, in patients with fibrosis, ischemic renal and heart failure were reported last year.
According to the company, the inhibitor of TRPC6 may also alleviate the damage to the lung and decrease the risk or severity of acute respiratory complications in patients hospitalised with COVID-19. Through the treatment with BI 764198, BI wants to reduce the need for ventilator support, improve patient recovery rate and save lives.
About a third of the 15% of diagnosed COVID-19 patients who develop severe disease are admitted to the intensive care unit (ICU). Approximately, 67 – 85% of this patient group develops ARDS. BI 764198 is designed to reduce severe respiratory distress caused by reactive oxygene species released due to airway injury. According to BI, ROS have been shown to activate TRPC6, which may cause a cascade of cellular damage resulting in disruption of cellular barrier function, hyper-permeability, edema and ultimately acute respiratory distress syndrome (ARDS). BI 764198 treatment in animal models of lung injury has been shown to reduce cellular damage and lung edema.
In the Phase II double-blinded, placebo-controlled trial BI 764198, hospitalised COVID-19 patients will get one dose per day for up to four weeks. The primary endpoint will be the percentage of survivors and patients that do not need mechanical ventilation at day 29. Other endpoints include clinical improvement, oxygen saturation and ICU admission.
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