Vicore Pharma has been given the green light by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to start a Phase II clinical trial assessing a potential COVID-19 therapy in record time.
The firm received approval for the study, which will evaluate VP01 in patients with COVID-19, SARS CoV- 2 infection, just four weeks after submitting a Letter of Intent to file a clinical trial application to the MHRA.
The study, named ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial), is targeting hospitalised patients treated with basic respiratory care, but not mechanical ventilation.
These patients have an intense inflammatory drive in the lungs which can lead to acute respiratory failure if it progresses.
VP01, a first in class low molecular weight angiotensin II receptor type 2 (AT2R) agonist, activates the ‘protective arm’ of the renin angiotensin system (RAS).
The RAS is understood to play a role in the development of COVID-19 because angiotensin II (ANG II) is upregulated and contributes to the inflammatory reaction in the lungs. The protective arm of the RAS is disarmed by SARS-CoV-2, which binds to the enzyme ACE2 and thereby inhibits the conversion of ANG II to endogenous protective molecules stimulating the AT2R.
Because VP01 directly stimulates the AT2R, researchers believe the drug could bypass the negative effects of viruses like SARS-CoV2 on the protective RAS functions, and according to Vicore internal preclinical findings with VP01 suggest that it may be useful in the treatment of COVID-19.
The drug is under development for idiopathic pulmonary fibrosis (IPF) and is also being studied in Raynaud’s phenomenon in patients with systemic sclerosis.
The company is working with clinical research organisation Orphan Reach on the drug’s development.