Barinthus Bio Initiates Phase 1 Clinical Trial of VTP-1000 for the Treatment of Celiac Disease

Rhea-AI Summary

Barinthus Biotherapeutics plc (NASDAQ: BRNS) has initiated a Phase 1 clinical trial of VTP-1000, an investigational immunotherapy for celiac disease. The AVALON trial (NCT06310291) aims to enroll 42 adults with celiac disease to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VTP-1000.

The trial consists of two parts: a single ascending dose (SAD) and a multiple ascending dose part with a controlled gluten challenge. VTP-1000 utilizes Barinthus Bio's proprietary SNAP-TI platform to deliver gluten-derived peptide antigens and rapamycin in nanoparticles, aiming to promote immune tolerance to gluten.

Celiac disease affects an estimated 1 in 100 people globally and currently has no approved treatments. VTP-1000 seeks to restore immune system tolerance to gluten, potentially reducing inflammation in the small intestine following gluten exposure.

Positive

• Initiation of first-in-human Phase 1 trial for VTP-1000 in celiac disease
• Addressing an unmet medical need with no current approved treatments
• Potential to restore immune tolerance to gluten in celiac patients

Negative

• None.

Insights

Medical Research Analyst

The initiation of a Phase 1 clinical trial for VTP-1000 in celiac disease is a significant milestone for Barinthus Bio. This study marks the company's first human trial using their proprietary SNAP-TI platform, which could potentially address a major unmet medical need. Key points to consider:

• Celiac disease affects an estimated 1% of the global population with no current FDA-approved treatments.
• VTP-1000's mechanism of action, combining gluten-derived peptides with rapamycin in nanoparticles, is innovative and aims to induce immune tolerance.
• The trial design, including a gluten challenge, will provide valuable early data on efficacy in addition to safety and tolerability.

While promising, investors should note that this is an early-stage trial and success is not guaranteed. The small sample size (42 participants) and focus on safety mean that definitive efficacy data will require future studies. However, positive results could significantly impact Barinthus Bio's valuation and attract partnership interest from larger pharmaceutical companies.

Financial Analyst

From a financial perspective, this clinical trial initiation is a positive development for Barinthus Bio, but investors should temper their expectations:

• With a market cap of only $48.48 million, BRNS is a micro-cap biotech stock, which inherently carries high risk.
• The celiac disease market is potentially lucrative, with some estimates valuing it at over $1 billion annually by 2030.
• However, cash burn will likely accelerate with this trial and Barinthus may need additional financing to complete the study and advance to later stages.

Investors should closely monitor the company's cash position and any potential dilutive events. While positive Phase 1 data could drive significant stock appreciation, the timeline to potential commercialization is long and many hurdles remain. This news may provide a short-term boost to the stock price, but long-term value will depend on continued clinical success and the company's ability to finance its operations.

• Investigational immunotherapy candidate, VTP-1000, seeks to address significant unmet need in people with celiac disease.
• An estimated one in 100 people globally suffer from celiac disease, for which no approved treatments currently exist.
• The first-in-human Phase 1 trial aims to evaluate the safety and tolerability in adults with celiac disease.
  

OXFORD, United Kingdom, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, announced the initiation of its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. The randomized, placebo-controlled clinical trial, which includes a controlled gluten challenge, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.

The Phase 1 AVALON trial (NCT06310291) aims to enroll 42 participants with celiac disease and will be conducted in two parts: a randomized double-blind placebo controlled single ascending dose (SAD) part, followed by a randomized double-blind placebo-controlled multiple ascending dose part, incorporating a controlled gluten challenge to assess the impact of VTP-1000 administration on patients’ exposure to gluten. 

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 to promote immune tolerance to gluten.

“When a person with celiac disease eats even small amounts of gluten, their body mounts an autoimmune response that causes inflammation resulting in rapid gastrointestinal symptoms and damage to the lining of the small intestine. This can be a burden in everyday life, as accidental ingestion is very common, and gluten avoidance can be difficult due to prevalence of the protein in the western diet,” said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio.

“Celiac disease remains an area that currently does not have any approved treatments. VTP-1000 aims to restore immune system tolerance to gluten and we are very excited to see VTP-1000 and the SNAP-TI platform in the clinic for the first time,” added Dr. Nadège Pelletier, Chief Scientific Officer of Barinthus Bio, “Restoring the correct balance of regulatory over pathogenic effector T cells aims to prevent or reduce inflammation in the small intestine following exposure to gluten.

About Celiac Disease

Celiac disease is caused by an autoimmune response to dietary gluten. It is relatively common, impacting an estimated one in 100 persons 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 Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, that utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms 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 chronic infectious diseases and autoimmunity. 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, the expected benefits of our product candidates, including VTP-1000, and our ability to develop and advance our current and future product candidates and programs. 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, our ability to fund our operations and access capital, 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, including our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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.

IR contacts:
Christopher M. Calabrese 
Managing Director 
LifeSci Advisors
+1 917-680-5608
ccalabrese@lifesciadvisors.com

Kevin Gardner
Managing Director
LifeSci Advisors
+1 617-283-2856
kgardner@lifesciadvisors.com

Media contact:
Audra Friis
Sam Brown, Inc.
+1 917-519-9577
audrafriis@sambrown.com

Company contact:
Jonothan Blackbourn
IR & PR Manager
Barinthus Bio
ir@barinthusbio.com

FAQ

What is the purpose of Barinthus Bio's Phase 1 AVALON trial for VTP-1000 (BRNS)?

The AVALON trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VTP-1000 in adults with celiac disease, including a controlled gluten challenge to assess its impact on patients' exposure to gluten.

How many participants is the Barinthus Bio (BRNS) Phase 1 trial for VTP-1000 aiming to enroll?

The Phase 1 AVALON trial aims to enroll 42 participants with celiac disease.

What technology does Barinthus Bio (BRNS) use in VTP-1000 for celiac disease treatment?

VTP-1000 utilizes Barinthus Bio's proprietary SNAP-TI platform to co-deliver multiple gluten-derived peptide antigens and the immunomodulator rapamycin in nanoparticles to promote immune tolerance to gluten.

What is the prevalence of celiac disease that Barinthus Bio (BRNS) is targeting with VTP-1000?

According to the press release, celiac disease affects an estimated one in 100 people globally.