Vicore Pharma doses first COVID-19 patient in the ATTRACT study in India
Ruby Hall Clinic, Pune, has dosed the first patient, two more sites are fully approved and are also expected to start enrollment this week and five more sites are being initiated. “With 40,000 new cases per day and still increasing, the prerequisites for a COVID-19 trial are dramatically different in India versus the UK”, says Mimi Flensburg, VP Clinical Development, Vicore Pharma.
The primary objective with the study, named ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial), is to investigate efficacy of VP01 (C21) on COVID-19 infection not requiring mechanical ventilation. These patients have an intense inflammatory drive in the lungs which can lead to acute respiratory failure if it progresses.
The study is a randomized, double-blind, placebo-controlled trial in approximately 100 hospitalized COVID-19 patients with moderately severe disease who will get 100 mg of VP01 or placebo twice daily for seven days. The study will investigate the efficacy on inflammation, respiratory failure, and functional outcomes.
First in class molecule
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). It is under development for idiopathic pulmonary fibrosis (IPF) and is also being studied in Raynaud’s phenomenon in patients with systemic sclerosis. Internal preclinical findings with VP01 suggest that it may also be useful in the treatment of COVID-19.
VP01 could bypass negative effects of COVID-19
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. Moreover, 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, the belief is that VP01 could bypass the negative effects of viruses like SARS-CoV-2 on the protective RAS functions.
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