Vicore Pharma Completes Enrollment in the Phase 2b ASPIRE Trial of Buloxibutid in Idiopathic Pulmonary Fibrosis
The randomized Phase 2b ASPIRE trial successfully completed planned enrollment of over 360 patients, reflecting strong execution and robust site engagement
ASPIRE is designed to assess the effect of buloxibutid on forced vital capacity (FVC) over 52 weeks, the regulatory endpoint for idiopathic pulmonary fibrosis (IPF)
Topline results are expected in mid-2027, supported by cash runway into the second half of 2028
STOCKHOLM, SE / ACCESS Newswire / April 22, 2026 / Vicore Pharma Holding AB (Nasdaq Stockholm:VICO), unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists (ATRAGs), today announced completion of enrollment in the global Phase 2b ASPIRE trial evaluating buloxibutid for the treatment of IPF.
The ASPIRE trial successfully enrolled more than 360 patients across over 100 sites in 14 countries, including 29 sites in the United States. Full trial enrollment was achieved earlier than anticipated, reflecting strong interest in buloxibutid and efficient trial execution.
"Completing enrollment in ASPIRE represents an important milestone for Vicore and the buloxibutid program," said Ahmed Mousa, Chief Executive Officer of Vicore. "We are encouraged by the excellent collaboration with dedicated sites and the high level of interest from investigators and patients globally, which enabled efficient recruitment ahead of our expectations. This level of engagement reflects both the significant unmet need in IPF and the desire for new therapies. With enrollment complete, our focus is on continued disciplined execution as we advance toward a topline data readout in mid-2027."
IPF remains a progressive and fatal lung disease with significant unmet medical need. Currently approved therapies have been shown to slow lung function decline, but the magnitude of benefit is limited, and treatment is frequently associated with tolerability challenges, underscoring the need for additional therapeutic options.
"IPF remains a serious and progressive disease with limited treatment options," said Toby Maher, MD, PhD, Professor of Clinical Medicine and Director of Interstitial Lung Disease at Keck Medicine of Southern California. "With enrollment in ASPIRE complete, I'm looking forward to the trial's results and continue to be optimistic about buloxibutid's potential to help address this persistent unmet medical need."
ASPIRE is a randomized, placebo-controlled, 52-week Phase 2b trial evaluating two doses of buloxibutid both as monotherapy and on top of background standard of care. The trial will measure the impact of buloxibutid on FVC over the 52-week treatment period, the regulatory endpoint for IPF. ASPIRE builds on encouraging results from Vicore's Phase 2a AIR trial in which buloxibutid treatment was associated with an improvement in FVC over 36 weeks.
Vicore expects to report topline results from ASPIRE in mid-2027 and is well positioned to execute the program with cash runway extending into the second half of 2028.
Vicore sincerely thanks the patients participating in the ASPIRE trial, as well as their families and caregivers, and the investigators, study staff, and clinical trial sites whose commitment and collaboration made this milestone possible.
For more information, please contact:
Megan Richards, VP, IR & Comms, +1 978 269 4372, megan.richards@vicorepharma.com
Hans Jeppsson, CFO, +46 70 553 14 65, hans.jeppsson@vicorepharma.com
About Vicore Pharma
Vicore Pharma is a clinical-stage biopharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The company's lead program, buloxibutid, is a first-in-class oral small molecule angiotensin II type 2 receptor agonist, which has received Orphan Drug and Fast Track designation from the United States Food and Drug Administration and is currently being investigated in the global 52-week Phase 2b ASPIRE trial in IPF.
Vicore is publicly listed on the Nasdaq Stockholm exchange with the ticker VICO. www.vicorepharma.com
About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a progressive fibrotic lung disease, impacting approximately 3 million people globally. The average life expectancy following diagnosis is 3-5 years, and currently approved therapies offer only modest slowing of disease progression. While there are three anti-fibrotic therapies available today, a large proportion of patients do not initiate treatment, and those who do often discontinue due to limited efficacy and significant tolerability issues. With a growing patient population, there is a clear need for new treatments.
About the Phase 2b ASPIRE Trial
ASPIRE (NCT06588686) is a global 52-week Phase 2b, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of buloxibutid in IPF patients who are either not currently on treatment or receiving background standard of care. Participants are randomized to receive one of two doses of buloxibutid (100 mg or 50 mg taken orally twice daily) or placebo. The primary endpoint is change from baseline in forced vital capacity (FVC) at 52 weeks, the registrational endpoint for IPF. Secondary endpoints include safety, tolerability, and the proportion of patients with disease progression over the trial period. The trial enrolled over 360 patients from more than 100 sites across 14 countries, including the United States.
SOURCE: Vicore Pharma Holding
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