XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug for the Treatment of Active Axial Spondyloarthritis

Rhea-AI Summary

XBiotech (NASDAQ:XBIT) announced FDA clearance to begin the Phase II V-SPINE (PT064) trial of vilamakitug in active axial spondyloarthritis. The IND completed the FDA’s 30-day review without clinical hold, allowing U.S. patient enrollment and marking the resumption of XBiotech’s rheumatology program under a leading expert advisory board.

Positive

• FDA 30-day IND review completed without clinical hold for V-SPINE
• Phase II V-SPINE trial of vilamakitug authorized to enroll U.S. patients
• Resumption of XBiotech’s rheumatology program with expert SPARTAN-led advisory board

Negative

• None.

News Market Reaction – XBIT

+0.43%

+0.43% Session close to close

In the Jun 15 session, XBIT gained 0.43%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights FDA clearance of the IND and the start of a Phase II, double-blind, pla...

Analysis

This announcement highlights FDA clearance of the IND and the start of a Phase II, double-blind, placebo-controlled study of vilamakitug in active axial spondyloarthritis after a 30-day review without clinical hold. It resumes XBiotech’s rheumatology program and complements prior oncology-focused trial work. Investors may watch enrollment progress, early safety signals, and future efficacy data to gauge how this program contributes to the broader True Human antibody pipeline.

Key Figures

FDA review period: 30-day Trial phase: Phase II

2 metrics

FDA review period 30-day Completion of IND review without clinical hold

Trial phase Phase II V-SPINE (PT064) vilamakitug study in axial spondyloarthritis

Previous Clinical trial Reports

1 past event · Latest: Jun 18 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 18	Clinical trial data	Positive	-13.5%	Promising Phase 1/2 pancreatic cancer results with Natrunix combination therapy.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Limited clinical-trial news history shows prior positive trial data coinciding with a negative price reaction.

Recent Company History

Over the past six months, XBiotech reported a key clinical trial update on Jun 18, 2024, with promising Phase 1/2 pancreatic cancer data using Natrunix. Despite improved tolerability and patient-reported outcomes in 65 subjects, the stock moved -13.49% over 24 hours. Today’s IND clearance and Phase II initiation in axial spondyloarthritis extend the company’s True Human antibody pipeline into rheumatology, following earlier oncology-focused progress.

Key Terms

investigational new drug (ind), double-blind, placebo-controlled, randomized, +2 more

6 terms

investigational new drug (ind) regulatory

"announced that its Investigational New Drug (IND) application for V-SPINE"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

double-blind technical

"a Phase II, double-blind, placebo-controlled, randomized study evaluating"

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.

placebo-controlled technical

"Phase II, double-blind, placebo-controlled, randomized study evaluating"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

randomized technical

"double-blind, placebo-controlled, randomized study evaluating the efficacy"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

axial spondyloarthritis medical

"vilamakitug in participants with active axial spondyloarthritis, has successfully"

A chronic inflammatory condition that mainly affects the spine and the joints connecting the lower spine to the pelvis, causing persistent back pain, stiffness and reduced mobility. For investors, it matters because its long-term nature and potential to impair daily function create steady demand for diagnostics, ongoing treatments, specialty drugs and sometimes surgery, making it a significant market for companies developing therapies and care-delivery solutions.

u.s. food and drug administration (fda) regulatory

"completed the U.S. Food and Drug Administration’s (FDA) 30-day review period"

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

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

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IND Application for V-SPINE Study Completes 30-Day FDA Review Without Clinical Hold, Clearing Path for U.S. Patient Enrollment

AUSTIN, Texas, June 15, 2026 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announced that its Investigational New Drug (IND) application for V-SPINE (PT064), a Phase II, double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of vilamakitug in participants with active axial spondyloarthritis, has successfully completed the U.S. Food and Drug Administration’s (FDA) 30-day review period without a clinical hold. The study is now authorized to proceed with patient enrollment in the United States, marking the resumption of XBiotech’s rheumatology program.

Study Chair and the Axial Spondyloarthritis Scientific Advisory Board

The clinical protocol was developed under the leadership of Study Chair Marina Magrey, M.D., and with expert guidance from a distinguished panel of SPARTAN leaders and rheumatology experts. Dr. Magrey serves as Division Chief of Rheumatology at University Hospitals Cleveland Medical Center, Professor of Medicine at Case Western Reserve University School of Medicine, and Vice-Chair of the Spondyloarthritis Research and Treatment Network (SPARTAN).

The advisory panel includes:

• Marina Magrey, M.D. — Division Chief of Rheumatology, University Hospitals Cleveland Medical Center; Professor of Medicine, Case Western Reserve University School of Medicine
• Atul Deodhar, M.D., M.R.C.P., FACR, FACP — Professor of Medicine and Medical Director of Rheumatology Clinics, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland
• Lianne S. Gensler, M.D. — Director of the UCSF Spondyloarthritis Research Program & Clinic; Professor of Medicine, University of California, San Francisco
• Walter P. Maksymowych, MB ChB, FRCP(C), FACP — Professor of Medicine, Division of Rheumatology, University of Alberta; Chief Medical Officer, CARE Arthritis Limited
• Michael A. Paley, M.D., Ph.D. — Assistant Professor of Medicine, Division of Rheumatology, Washington University in St. Louis
• John A. Carino, M.D., M.P.H., FACR — Vice-Chairman, Radiology and Imaging; Professor of Radiology, Weill Cornell Medicine
  
  

About the V-SPINE Study

PT064 will evaluate 400 mg of vilamakitug administered as 16 weekly subcutaneous injections versus placebo in 150 adult participants with active axial spondyloarthritis (axSpA). The primary endpoint is the proportion of participants achieving an ASAS40 response at Week 16. The study also includes a 12-week open-label extension in which all participants receive vilamakitug. Despite the availability of approved biologic therapies, a substantial proportion of patients continue to experience inadequate disease control, representing a significant and persistent unmet medical need.

“The unmet need in axial spondyloarthritis remains real and substantial. IL-1α is a compelling upstream target, hypothesized to play a role in the inflammation, bone erosion, and chronic pain that define this disease. The PT064 protocol is rigorously designed to test whether targeting this upstream pathway translates into meaningful clinical benefit, and I am pleased to have contributed to its development. FDA clearance of the protocol is an important milestone, and I look forward to seeing this study advance for the benefit of patients.”
— Marina Magrey, M.D., PT064 Study Chair

“FDA clearance of the PT064 protocol is a significant step forward for our vilamakitug program and for patients living with axial spondyloarthritis. Vilamakitug is a True Human™ antibody indistinguishable from one naturally occurring in a healthy person with immunity to IL-1α, and we believe it represents a meaningful new approach to treating the inflammation that drives this disease. We are grateful to the members of our axSpA Scientific Advisory Board for their expert guidance in shaping this protocol, and we plan to move expeditiously into enrollment.”
— Sushma Shivaswamy, Ph.D., Interim Chief Executive Officer and Chief Scientific Officer, XBiotech

About Vilamakitug

Vilamakitug (also known as XB2001 and Natrunix™) is an IgG4 monoclonal antibody that neutralizes interleukin-1α (IL-1α), a proximal pro-inflammatory cytokine that can contribute to synovial and entheseal inflammation, osteoclast-mediated bone resorption, cartilage degradation, and inflammatory joint pain in spondyloarthritis. By targeting this upstream inflammatory mediator, vilamakitug is hypothesized to reduce both structural damage and disease activity, including in patients who have had an inadequate response to currently approved biologic therapies.

About XBiotech

XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies across inflammatory disorders, oncology, infectious disease, and dermatology by harnessing naturally occurring antibodies from patients with immunity to certain diseases. Utilizing natural human immunity as a source of new medicines offers the potential to redefine the standards of care for a wide range of diseases.

XBiotech has a deep and continuing history in rheumatology. The Company previously developed and clinically advanced bermekimab, a True Human™ anti-IL-1α antibody evaluated across multiple inflammatory diseases. On December 30, 2019, XBiotech sold bermekimab in a transaction valued at up to $1.35 billion, retaining the right to develop True Human™ anti-IL-1α antibodies in all areas of medicine outside of dermatology. PT064 marks the continuation of that rheumatology legacy, as XBiotech advances vilamakitug — its next-generation True Human™ IL-1α antibody — into a pivotal Phase II study in axial spondyloarthritis. For more information, visit www.xbiotech.com.

About True Human™ Therapeutic Antibodies

XBiotech's True Human™ antibodies are antibodies derived without modification from humans who possess natural immunity to certain diseases. XBiotech's True Human™ antibodies are directly sourced from the natural human immune response without modification. XBiotech's True Human™ antibodies have the potential to harness the body's natural immunity to fight disease.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. Forward-looking statements are not guarantees of future performance. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact

Wenyi Wei
publicrelations@xbiotech.com
tel. 737-207-4600

FAQ

What did XBiotech (NASDAQ:XBIT) announce on June 15, 2026 about vilamakitug?

XBiotech announced FDA clearance to initiate the Phase II V-SPINE study of vilamakitug for active axial spondyloarthritis. According to XBiotech, the IND completed the FDA’s 30-day review without clinical hold, enabling U.S. patient enrollment in this randomized, placebo-controlled trial.

What is the V-SPINE (PT064) Phase II trial in XBiotech’s XBIT pipeline?

V-SPINE (PT064) is a Phase II, double-blind, placebo-controlled, randomized study of vilamakitug in active axial spondyloarthritis. According to XBiotech, the trial is designed to evaluate the efficacy and safety of vilamakitug and is now authorized to begin enrolling patients in the United States.

What does FDA completion of the 30-day IND review without clinical hold mean for XBiotech (XBIT)?

Completion of the FDA’s 30-day IND review without clinical hold allows XBiotech to proceed with the V-SPINE Phase II trial. According to XBiotech, this authorization clears the path for U.S. patient enrollment and marks the restart of the company’s rheumatology development program.

How does the V-SPINE Phase II trial impact XBiotech’s rheumatology program?

The V-SPINE Phase II trial marks the resumption of XBiotech’s rheumatology program. According to XBiotech, initiating this axial spondyloarthritis study with vilamakitug reactivates clinical development in rheumatology and is supported by leadership from established SPARTAN and rheumatology experts.

Who is leading XBiotech’s V-SPINE Phase II study for axial spondyloarthritis?

The V-SPINE study is led by Study Chair Marina Magrey, M.D., a rheumatology division chief and SPARTAN vice-chair. According to XBiotech, she is supported by an advisory panel of leading rheumatologists from institutions including Oregon Health & Science University, UCSF, Alberta, Washington University, and Weill Cornell.

What condition is targeted in XBiotech’s V-SPINE Phase II vilamakitug trial (XBIT)?

The V-SPINE Phase II trial targets active axial spondyloarthritis. According to XBiotech, the randomized, placebo-controlled study will evaluate vilamakitug’s efficacy and safety in participants with this inflammatory rheumatologic condition, following FDA clearance of the IND without clinical hold.