Barinthus Bio Announces Update on Phase 1 AVALON Clinical Trial of VTP-1000 for the Treatment of Celiac Disease
Rhea-AI Summary
Barinthus Bio (NASDAQ: BRNS) reported Phase 1 AVALON SAD results for VTP-1000 in adults with celiac disease showing a dose-dependent pharmacological effect and good tolerability.
The SAD enrolled 18 patients across three placebo-controlled, ascending-dose cohorts (NCT06310291); there were no treatment-related serious adverse events. The MAD portion, which includes a gluten challenge, is ongoing with additional data expected in H2 2026. VTP-1000 uses the SNAP-TI platform to co-deliver gluten-derived peptides (wheat, barley, rye) with rapamycin in nanoparticles aimed at promoting immune tolerance.
The company plans to present detailed pharmacology and immunology data at a scientific conference in 2026.
Positive
- SAD showed a dose-dependent pharmacological effect
- No treatment-related serious adverse events in SAD
- SAD enrolled 18 patients across three placebo-controlled cohorts
- VTP-1000 uses SNAP-TI platform with peptide+rapamycin delivery
Negative
- SAD size was limited to 18 patients, constraining statistical power
- MAD results and clinical efficacy data are not yet available (expected H2 2026)
Key Figures
Market Reality Check
Peers on Argus
Peers showed mixed moves, with PSTV up 6.35%, IPSC up 7.58%, TPST up 1.59%, while ANVS fell 0.89% and RADX fell 8.84%, suggesting stock-specific factors for BRNS.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 07 | Earnings and merger | Positive | -10.1% | Q3 2025 results, cash update, and all-stock merger details with Clywedog. |
| Oct 24 | Merger services update | Positive | +3.1% | ChemDiv support for merged Clywedog-Barinthus R&D and pipeline plans. |
| Sep 30 | Strategic merger | Neutral | -15.5% | Announcement of all-stock merger creating Clywedog Therapeutics with 66/34 split. |
| Aug 07 | Earnings and pipeline | Positive | +10.7% | Q2 2025 results, VTP‑1000 AVALON progress, and cash runway commentary. |
Recent news has produced mixed reactions: merger and earnings updates sometimes sold off despite strategic positioning, while one earnings update was bought. Market responses to corporate and clinical updates have not been consistently positive.
Over the last few months, Barinthus Bio has focused on a strategic merger with Clywedog and advancing its immunology pipeline, including VTP‑1000. On Aug 07 and Nov 07 2025, Q2 and Q3 earnings highlighted cash runway into 2027 and progress in the AVALON Phase 1 trial. Multiple announcements from Sep 30 and Oct 24 detailed the all-stock combination into Clywedog Therapeutics with Clywedog holders owning 66% of the combined company. Today’s VTP‑1000 Phase 1 SAD update follows those earlier clinical and corporate milestones.
Market Pulse Summary
This announcement highlights Phase 1 AVALON SAD data for VTP‑1000 in celiac disease, showing a dose‑dependent pharmacological effect and no treatment‑related serious adverse events across 18 patients. The multiple ascending dose portion, including a gluten challenge, is ongoing with data expected in H2 2026. In recent quarters, Barinthus has emphasized an immunology focus and a planned merger with Clywedog, so future updates on MAD outcomes, merger closing, and cash usage will be important reference points.
Key Terms
serious adverse events medical
single ascending dose medical
multiple ascending dose medical
IL-2 medical
AI-generated analysis. Not financial advice.
- VTP-1000, an antigen-specific immunotherapy to treat celiac disease, showed a dose-dependent pharmacological effect in the SAD portion of the trial
- VTP-1000 was well-tolerated with no treatment-related SAEs
- The MAD portion of the trial, which includes a gluten challenge, is ongoing
GERMANTOWN, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and inflammation (“I&I”) company focused on developing immune tolerance therapies with curative potential, today announced an update on its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. In the single ascending dose (“SAD”) portion of the trial, VTP-1000 was well tolerated with no treatment-related serious adverse events (“SAEs”) and a dose-dependent pharmacological effect observed. The multiple ascending dose (“MAD”) portion of the trial, which includes a gluten challenge, is ongoing with data expected in the second half of 2026.
The SAD portion of the Phase 1 AVALON trial (NCT06310291) enrolled 18 patients in three placebo-controlled cohorts of ascending doses. VTP-1000 was well tolerated at all dose levels with no treatment-related SAEs. Pharmacological data collected showed a dose-dependent effect.
“I’m encouraged by the results from VTP-1000, the first antigen-specific immune tolerance therapy for celiac disease to utilize an immunomodulator," said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio. "The treatment was well-tolerated across all dose levels, with no therapy related serious adverse events. Importantly, the IL-2 response observed at all doses together with the safety data demonstrates immune recognition without serious inflammation. These dose-dependent pharmacological effects are promising, and upcoming results from multiple dosing and further immunological analysis will be critical in refining the optimal regimen and understanding the therapy's potential for true disease modification and patient benefit.”
VTP-1000 is an investigational, injectable antigen-specific tolerance immunotherapy that utilizes Barinthus Bio’s proprietary SNAP-TI platform to co-deliver multiple gluten-derived peptide antigens (from wheat, barley and rye proteins) and the immunomodulator rapamycin in nanoparticles designed to promote immune tolerance to gluten.
"These data from the SAD portion of the AVALON trial demonstrate the ability of a single dose of VTP-1000 to stimulate a robust targeted immune response that may minimize adverse effects associated with gluten antigen exposure in patients with celiac disease,” said Bill Enright, Chief Executive Officer of Barinthus Bio. "We look forward to providing details of the data, including pharmacological responses, at a scientific conference in 2026.”
About Celiac Disease
Celiac disease is caused by an autoimmune response to dietary gluten. It is relatively common, impacting an estimated one in 100 people of all ages (approximately 80 million people globally) and increasing in incidence. When people with celiac disease eat even small amounts of gluten-containing foods, their body mounts an autoimmune response consisting of T effector cells that cause inflammation. This can lead to rapid onset of symptoms (vomiting, diarrhea, etc.), as well as damage to the mucosal lining of the small intestine that can cause long-term consequences (e.g., malnutrition and vitamin deficiencies). Celiac disease is an area of high unmet need with no currently approved treatments; instead, people with celiac disease are advised to strictly avoid consuming gluten, which can be difficult due to the presence of gluten in many foods and cross-contamination of food production surfaces.
About Barinthus Bio
Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases with curative potential. Barinthus Bio's pipeline for I&I indications is enabled by our proprietary and highly differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient's T cells to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease and is currently in a Phase 1 clinical trial. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune and inflammatory diseases. For more information, visit www.barinthusbio.com.
Forward Looking Statements
This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, our anticipated regulatory filings and approvals, our cash runway, our ability to develop and advance our current and future product candidates and programs, and the terms and timing of the restructuring and related activities. Any forward-looking statements in this press release are based on our management’s current expectations and beliefs and are subject to numerous 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 related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission (the “SEC”), including our most recent annual report on Form 10-K and subsequent filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim 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.
Media contacts:
Alexis Feinberg
Vice President
ICR Healthcare
Barinthus@icrinc.com
Jonathan Edwards
Associate Partner
ICR Healthcare
Barinthus@icrinc.com
Company contact:
ir@barinthusbio.com
FAQ
What did Barinthus Bio announce about VTP-1000 on December 10, 2025 (BRNS)?
How many patients were enrolled in the AVALON SAD trial for BRNS VTP-1000?
When will Barinthus Bio (BRNS) report MAD data and the gluten challenge results?
Were there any serious adverse events reported in the VTP-1000 SAD portion (BRNS)?
What is VTP-1000 and how does it work for celiac disease (BRNS)?
Will Barinthus Bio present detailed VTP-1000 data publicly (BRNS)?
