Moderna Announces First Participant Dosed in Pivotal Phase 3 Trial of Investigational mRNA Norovirus Vaccine, mRNA-1403

Rhea-AI Summary

Moderna has announced the dosing of the first participant in the Nova 301 Trial, a pivotal Phase 3 clinical trial for its investigational mRNA norovirus vaccine, mRNA-1403. The trial aims to evaluate the efficacy, safety, and immunogenicity of the vaccine in preventing moderate to severe norovirus acute gastroenteritis (AGE) in adults.

The study plans to enroll approximately 25,000 participants globally, with a focus on adults 60 years and older who are at higher risk of severe outcomes. The trial will be conducted in various countries across the Northern Hemisphere, equatorial region, and Southern Hemisphere.

Norovirus is a significant public health concern, causing millions of infections worldwide annually and resulting in approximately 200,000 deaths per year. mRNA-1403 is a trivalent formulation designed to protect against multiple norovirus genotypes by encoding for virus-like particles (VLPs).

Positive

• Advancement to Phase 3 clinical trial for mRNA-1403 norovirus vaccine
• Large-scale global trial with 25,000 participants across multiple regions
• Potential to address a significant public health concern affecting millions globally
• Focus on high-risk population (adults 60 years and older)

Negative

• None.

Insights

Medical Research Analyst

The initiation of Moderna's Phase 3 trial for mRNA-1403, an investigational norovirus vaccine, marks a significant milestone in addressing a major public health concern. Norovirus affects millions globally, causing severe gastroenteritis and sometimes requiring hospitalization. The trial's large scale, with 25,000 participants across multiple countries, demonstrates the potential for widespread impact.

Key points to consider:

• Focus on high-risk group: 20,000 participants aged 60+, targeting those most vulnerable to severe outcomes.
• Global reach: Trial conducted in Northern and Southern Hemispheres, ensuring diverse population representation.
• Potential market: Norovirus causes 200,000 deaths annually with substantial healthcare costs, indicating a significant market opportunity if successful.
• Innovative approach: mRNA-1403 uses Moderna's proven mRNA technology, encoding for virus-like particles to protect against multiple norovirus genotypes.

This trial could lead to a breakthrough in preventing a common yet serious illness, potentially reducing healthcare burdens and improving public health outcomes globally.

Financial Analyst

Moderna's advancement to Phase 3 trials for its norovirus vaccine candidate is a positive development for the company's pipeline diversification strategy. Key financial implications include:

• Market potential: With norovirus causing 18% of all acute gastroenteritis cases globally, a successful vaccine could tap into a substantial market, potentially driving significant revenue growth.
• R&D investment: The large-scale trial (25,000 participants) represents a considerable financial commitment, indicating Moderna's confidence in the product's potential.
• Risk mitigation: Expanding beyond COVID-19 vaccines helps Moderna diversify its revenue streams, reducing reliance on a single product line.
• Long-term value: Success in this trial could strengthen Moderna's position in the vaccine market, potentially increasing shareholder value and attracting more institutional investors.

While the financial impact is not immediate, positive trial results could significantly influence Moderna's future revenue projections and stock performance. Investors should monitor trial progress and potential regulatory milestones as indicators of the vaccine's commercial viability.

CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first participant in the U.S. has been dosed in the Nova 301 Trial, a pivotal Phase 3 randomized clinical trial evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403. Global recruitment for the Nova 301 trial has also begun.

"Norovirus is a significant public health concern that affects millions of people worldwide each year, leading to severe symptoms and, in some cases, hospitalization," said Stéphane Bancel, CEO of Moderna. "By advancing our investigational norovirus vaccine into a pivotal Phase 3 trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally."

The Nova 301 Phase 3 trial is a randomized, observer-blind, placebo-controlled trial evaluating the efficacy, safety and immunogenicity of mRNA-1403. The trial aims to enroll approximately 25,000 participants 18 years of age and older globally, including in countries in the Northern Hemisphere (U.S., Canada, UK, Japan), the equatorial region, and the Southern Hemisphere (Australia and countries in South America). Approximately 20,000 participants 60 years of age and older and 5,000 participants between 18 and 59 years of age will be enrolled to assess the investigational vaccine's ability to protect against moderate to severe norovirus acute gastroenteritis (AGE) in adults, with a focus on the older age group that is at greatest risk of severe outcomes including hospitalization.

Enteric viruses, including norovirus, are a leading cause of diarrheal diseases, resulting in significant morbidity and mortality worldwide, particularly among young children and older adults. Norovirus is highly contagious and a leading cause of diarrheal disease globally, associated with 18% of all AGE,¹ resulting in approximately 200,000 deaths per year and substantial healthcare costs.²

mRNA-1403 is an mRNA vaccine in development to prevent moderate to severe acute gastroenteritis caused by norovirus. The vaccine candidate is a trivalent formulation containing mRNA that encodes for virus-like particles (VLPs) designed to protect against multiple norovirus genotypes.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

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 statements regarding: the potential for mRNA-1403 to prevent infection from norovirus; and anticipated enrollment in the Nova 301 Phase 3 trial. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

¹ Ahmed, S.M., et al., Global prevalence of norovirus in cases of gastroenteritis: a systematic review and meta-analysis. Lancet Infect Dis, 2014
² https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/norovirus

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

FAQ

What is the purpose of Moderna's Nova 301 Trial for mRNA-1403?

The Nova 301 Trial is a Phase 3 clinical trial evaluating the efficacy, safety, and immunogenicity of Moderna's investigational mRNA norovirus vaccine, mRNA-1403, in preventing moderate to severe acute gastroenteritis caused by norovirus in adults.

How many participants will be enrolled in Moderna's Phase 3 trial for mRNA-1403?

Moderna aims to enroll approximately 25,000 participants globally in the Phase 3 trial for mRNA-1403, including 20,000 participants aged 60 and older and 5,000 participants between 18 and 59 years of age.

What is the target population for Moderna's norovirus vaccine trial (MRNA)?

The trial focuses on adults, with a particular emphasis on those 60 years of age and older who are at the greatest risk of severe outcomes, including hospitalization from norovirus infection.

In which countries will Moderna conduct the Phase 3 trial for mRNA-1403?

The trial will be conducted globally, including countries in the Northern Hemisphere (U.S., Canada, UK, Japan), the equatorial region, and the Southern Hemisphere (Australia and countries in South America).