Vicore Pharma is looking to move ahead with the Phase IIb trial of its lead pipeline candidate buloxibutid after a successful Phase IIa trial in idiopathic pulmonary fibrosis (IPF).

The Sweden-based biopharma announced data from the Phase IIa trial of buloxibutid in patients with IPF at the 2024 American Thoracic Society (ATS) International Congress in San Diego.

Buloxibutid (C21) is an orally available low molecular weight angiotensin II type 2 receptor (AT2R) agonist that activates the protective arm of the renin-angiotensin system (RAS).

The AIR trial (NCT04533022) was a multicentre, open-label, single-arm trial investigating buloxibutid 100mg taken orally twice daily in treatment-naïve patients with IPF for up to 36 weeks.

The trial met both its primary and secondary endpoints, improving lung function, measured by forced vital capacity (FVC), by more than 200mL from baseline. Meanwhile, untreated patients saw a decline of approximately 180mL over 36 weeks.

The data also showed increased plasma levels of the collagenase MMP-13 and reflected a trend of decreased plasma levels of the profibrotic cytokine TGF beta 1, both of which are biomarkers that indicate disease modification in IPF patients.

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Buloxibutid was also safe and well-tolerated with no drug-related serious adverse events and good gastrointestinal tolerability.

As a result of the positive data, Vicore plans to initiate the Phase IIb ASPIRE trial of buloxibutid in H1 2024. The Phase IIb trial will be a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study. ASPIRE will enrol patients being treated with the standard of care IPF therapy nintedanib and those not on standard of care, and the primary endpoint will be a change from baseline in FVC at 52 weeks.

Vicore has also investigated buloxibutid in endothelial dysfunction and Covid-19 patients during the height of the pandemic.

IPF landscape

The current key players in the IPF market are Ofev and Esbriet, developed respectively by Boehringer Ingelheim and Roche. Both Ofev and Esbriet have been shown to slow the progression of the disease but do not improve IPF’s fatal prognosis, identifying a key unmet need for this disease.

There are however a handful of newcomers in the late-stage pipeline landscape, including FibroGen and United Therapeutics, which GlobalData predicts will have an impact on the market.

A report by GlobalData predicts that the global IPF market will increase across the 7 major markets (US, France, Germany, Italy, Spain, UK and Japan)  from $2.4bn to $4bn at a compound annual growth rate (CAGR) of 5.3%.

GlobalData is the parent company of the Clinical Trials Arena.