Pharma Focus Asia

Vicore Announces Favorable Outcomes from Phase 2a AIR Trial, Showing Buloxibutid's 36-Week Lung Function Improvement in Idiopathic Pulmonary Fibrosis Patients

Monday, May 20, 2024

Vicore Pharma Holding AB (STO: VICO) recently disclosed the encouraging final results from its Phase 2a AIR trial, evaluating buloxibutid (C21) for idiopathic pulmonary fibrosis (IPF).

During the American Thoracic Society (ATS) International Congress on May 19th, Vicore Pharma shared conclusive data from the Phase 2a AIR trial. This trial assessed buloxibutid (100 mg orally twice daily) in a multicenter, open-label, single-arm study involving treatment-naïve IPF patients for up to 36 weeks.

The outcomes were positive for both primary and secondary endpoints, indicating notable safety, tolerability, and efficacy. Over the 36-week treatment period, buloxibutid showed an improvement in lung function, measured by forced vital capacity (FVC), surpassing the anticipated decline seen in untreated patients. FVC increased by an average of 216 mL from baseline to week 36, nearly 400 mL more than the untreated trajectory (n=28, p<0.001). Notably, FVC enhancement from baseline after 36 weeks of treatment was observed across all analyzed subgroups (geography, gender, and radiologic pattern). Additionally, the majority of patients who completed treatment since the last interim analysis in May 2023 witnessed FVC improvement from baseline at 36 weeks.

Moreover, buloxibutid demonstrated favorable safety and tolerability profiles throughout the 36-week treatment duration, with no drug-related serious adverse events and good gastrointestinal tolerability. At weeks 12 and 24, medical evaluations were conducted by investigators to assess the benefit/risk for patients to continue in the trial without standard of care therapy for IPF. At each evaluation, 97% of patients were deemed to have a positive benefit/risk and chose to continue treatment. More detailed insights will be provided during the Company-hosted webinar on May 22nd.

Professor Toby Maher from the Keck School of Medicine at the University of Southern California expressed optimism about the results, highlighting the potential of buloxibutid to halt disease progression, restore lung function, and enhance outcomes for IPF patients in a safe and well-tolerated manner.

The mechanism of action of buloxibutid aligns with the observed improvement in lung function, as evidenced by increased plasma levels of the collagenase MMP-13 and a trend towards decreased plasma levels of the profibrotic cytokine TGF?1 over the 36-week study period.

These promising results support the progression of buloxibutid to the Phase 2b ASPIRE trial, which will further evaluate its efficacy. CEO Ahmed Mousa expressed confidence in the continued development of buloxibutid for IPF, emphasizing its disease-modifying potential based on biomarker data and the significant improvement in FVC over 36 weeks. This advancement brings the company closer to its goal of impacting the future standard of care for IPF patients.

 

Source: vicorepharma.com

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