Vicore's Phase 2b ASPIRE Trial of Buloxibutid in IPF Passes Pre-Planned Futility Analysis and Remains on Track for Mid-2027 Topline Results

The independent committee also raised no concerns in its safety and benefit-risk review of all available data.

Rhea-AI Summary

Vicore Pharma (VCRE) announced that its Phase 2b ASPIRE trial of buloxibutid in idiopathic pulmonary fibrosis passed a pre-planned futility analysis. The independent Data Monitoring Committee recommended continuing without modification and raised no concerns in its separate safety and benefit-risk review.

The analysis examined the change in forced vital capacity, a lung-function measure, at 52 weeks for 100 mg twice daily versus placebo. It covered approximately the first 100 randomized patients who completed 52 weeks or discontinued, around 27% of enrollment. The pre-specified stopping criterion was conditional power below 20%; that criterion was not met. Vicore remains blinded to trial data. Enrollment finished ahead of schedule in April 2026 with 378 patients. The company expects topline results in mid-2027 and says its cash runway extends into the second half of 2028.

5 points · 0 major

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointASPIRE passed its pre-planned futility analysis, with the independent committee recommending continuation without modification.
• Moderate point378 patients randomized; enrollment completed ahead of schedule in April 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash runway into the second half of 2028 extends beyond the expected readout, the company says.
• Minor pointSafety and benefit-risk review of all available data raised no concerns.
• Minor point. Forward-looking: it has not happened yet and may not happen.52-week topline results remain expected in mid-2027.

Negative

• Minor pointFutility assessment covered around 27% of enrolled patients and evaluated the high dose versus placebo.

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Market move: VCRE +16.27% vs previous close. Phase 2b futility analysis

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Key Figures

Enrollment: 378 patients Futility analysis population: Approximately the first 100 randomized patients; around 27% of enrolled patients Primary endpoint: Change from baseline in FVC at 52 weeks +4 more

Enrollment

378 patients

Enrolled in the Phase 2b ASPIRE trial

Futility analysis population

Approximately the first 100 randomized patients; around 27% of enrolled patients

Patients had completed 52 weeks of treatment or discontinued

Primary endpoint

Change from baseline in FVC at 52 weeks

ASPIRE primary endpoint

Futility threshold

Conditional power below 20%

Pre-specified threshold for considering stopping the trial for futility

Dose assessed

100 mg twice daily

High dose assessed versus placebo in the futility analysis

Topline results

Mid-2027

Expected timing for 52-week ASPIRE topline results

Cash runway

Into the second half of 2028

Company-stated runway extends beyond the expected readout

Key Terms

idiopathic pulmonary fibrosis, forced vital capacity, conditional power, futility analysis, +1 more

5 terms

idiopathic pulmonary fibrosis medical

"buloxibutid in idiopathic pulmonary fibrosis (IPF)"

Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.

forced vital capacity medical

"change from baseline in forced vital capacity (FVC) at Week 52"

The amount of air a person can forcefully breathe out after taking the deepest breath possible; think of it as how much air you can squeeze out of a balloon in one hard blow. It matters to investors because it’s a common, objective measure used in clinical trials and patient monitoring for respiratory drugs, devices and treatments—changes in this number can signal whether a therapy works, affecting regulatory approval, sales and company value.

conditional power technical

"It used a conditional power approach"

Conditional power is the probability that a clinical trial or statistical test will produce a statistically significant result at its planned end, calculated at an interim point and conditioned on the data observed so far and an assumption about the unknown future treatment effect. It is computed by taking the current test statistic and sample size, projecting the distribution of future observations under a specified effect size (often the originally hypothesized effect or the effect observed to date), and estimating the chance the final analysis will cross the prespecified significance threshold; its value can change substantially depending on which future-effect assumption is used and on any planned changes to the study design.

futility analysis technical

"following a pre-planned futility analysis"

A futility analysis is a planned mid-course check in a clinical trial to determine whether continuing the study is unlikely to show a meaningful benefit. Think of it like pausing a long road trip to see if you’re close enough to your destination to justify the remaining time and fuel; if not, the trial may be stopped early to limit costs and risk. For investors, futility results can sharply change a company’s timeline, spending needs and the likelihood of regulatory approval, which in turn affects valuation.

double-blind medical

"52-week Phase 2b, randomized, double-blind, placebo-controlled clinical trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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STOCKHOLM, SE AND CAMBRIDGE, MA / ACCESS Newswire / October 22, 2026 / Vicore Pharma Holding AB (Nasdaq Stockholm:VICO)(Nasdaq US:VCRE), a biopharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists, today announced that the independent Data Monitoring Committee (iDMC) for the Phase 2b ASPIRE trial of buloxibutid in idiopathic pulmonary fibrosis (IPF) recommended that the trial continue without modification following a pre-planned futility analysis. In parallel, the iDMC conducted its regular safety and benefit-risk review of all available data and raised no concerns. ASPIRE continues as planned and remains on track to report 52-week topline results in mid-2027.

"Passing this futility analysis is an important milestone that allows ASPIRE to continue as designed. With 378 patients enrolled and a 52-week FVC primary endpoint, ASPIRE was built to generate a high-quality dataset, and our focus remains on disciplined execution through database lock and expected topline results in mid-2027," said Ahmed Mousa, Chief Executive Officer of Vicore Pharma. "Our cash runway into the second half of 2028 takes us beyond the readout and allows us to plan the next steps for the program and the company."

"The futility analysis was designed to protect patients and allow us to preserve the integrity of the trial, and we thank the iDMC for its independent review," said Bernt van den Blink, MD, PhD, Chief Medical Officer of Vicore Pharma. "We look forward to the final assessment of the efficacy and safety of buloxibutid next year. We are grateful to the patients, investigators and site staff whose commitment makes this trial possible."

The futility analysis assessed whether the trial should stop early for futility. The futility criteria were not met, and the iDMC recommended that the trial continue without modification. The analysis was conducted by an external statistician and reviewed by the iDMC, based on efficacy data from approximately the first 100 randomized patients who had completed 52 weeks of treatment or discontinued from the trial, representing around 27% of the enrolled patients. The analysis assessed the primary endpoint, the change from baseline in forced vital capacity (FVC) at Week 52, for the high dose of buloxibutid (100 mg twice daily) versus placebo. It used a conditional power approach, with a pre-specified threshold to consider stopping the trial for futility if conditional power was below 20%.

Vicore remains blinded to the trial data. To preserve trial integrity, no quantitative results, such as treatment effect estimates or conditional power values, were disclosed to the company.

For further information, please contact:
Hans Jeppsson, Chief Financial Officer, +46 (0)70 553 14 65, hans.jeppsson@vicorepharma.com

About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a progressive and lethal fibrotic lung disease impacting approximately 250,000 people across the United States and Europe. The average life expectancy following diagnosis is 3-5 years, and currently approved therapies only slow the decline of lung function. While there are three antifibrotic 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 disease-modifying treatments.

About the Phase 2b ASPIRE Trial
ASPIRE is an ongoing 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 are receiving standard of care (nintedanib or nerandomilast). Participants are randomized to receive one of two doses of buloxibutid (50 mg or 100 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 completed enrollment in April 2026, with 378 patients randomized across over 100 sites in 14 countries, including the United States. Recruitment was completed ahead of schedule, positioning the company to report topline results in mid-2027.

About Vicore Pharma Holding AB
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 an oral small-molecule angiotensin II type 2 receptor agonist, which received Orphan Drug and Fast Track designations 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 Pharma is publicly listed on Nasdaq Stockholm (VICO) and Nasdaq US (VCRE). www.vicorepharma.com

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the ongoing Phase 2b ASPIRE clinical trial; the potential clinical benefits, safety, and efficacy of buloxibutid; clinical development timelines, including expected timing of topline data from the ASPIRE trial and continued development plans for buloxibutid, strategic and business plans, financial position and the anticipated cash runway. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties inherent in clinical development (including that interim or early data may not be predictive of later or final results and data from a small sample size may not be indicative of results that may be observed in a larger group), clinical trial execution risks, the occurrence of adverse safety events, and references to those risks identified in the section entitled "Risk Factors" in Vicore Pharma's filings with the U.S. Securities and Exchange Commission and discussed in Vicore Pharma's Swedish filings and its press releases. Vicore Pharma cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Vicore Pharma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Vicore Pharma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

This information is information that Vicore Pharma Holding is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-10-22 18:50 CEST.

Attachments
Vicore's Phase 2b ASPIRE Trial of Buloxibutid in IPF Passes Pre-Planned Futility Analysis and Remains on Track for Mid-2027 Topline Results

SOURCE: Vicore Pharma Holding

View the original press release on ACCESS Newswire

FAQ

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What did Vicore's ASPIRE futility analysis show?

The pre-specified futility criterion was not met, and the independent Data Monitoring Committee recommended continuing ASPIRE without modification. Its separate safety and benefit-risk review raised no concerns. Vicore remains blinded to the trial data.

When does Vicore expect ASPIRE topline results?

Vicore expects 52-week topline results in mid-2027. The trial completed enrollment ahead of schedule in April 2026, with 378 patients randomized.

What treatments and outcomes is Vicore testing in ASPIRE?

ASPIRE compares buloxibutid at 50 mg or 100 mg orally twice daily with placebo over 52 weeks. Patients are either not currently on treatment or receiving nintedanib or nerandomilast. The primary endpoint is change from baseline in forced vital capacity, a lung-function measure; secondary endpoints include safety, tolerability and the proportion of patients with disease progression.