In short
MRT1800 is an investigational mRNA vaccine being studied for the treatment of moderate to severe acne. A single Phase 1/2 clinical trial (NCT06316297) is authorised and plans to enrol 549 adult participants. The trial will assess the safety, efficacy, and immunogenicity of MRT1800 given by intramuscular injection.
Key points
- MRT1800 is an investigational mRNA vaccine for moderate to severe acne.
- The only registered trial is a Phase 1/2 study authorised to enrol 549 adults.
- The vaccine is given by intramuscular injection.
- The trial measures safety, efficacy, and immunogenicity.
- The primary efficacy measure is the percentage change in inflammatory acne lesions on the face.
- The trial is currently authorised, not yet recruiting.
What is MRT1800?
MRT1800 is an investigational mRNA vaccine being developed for the treatment of moderate to severe acne. It is not an authorised medicine. The substance is being studied as a vaccine, which means it is designed to stimulate the immune system rather than to act directly on the skin. In the clinical trial register, MRT1800 is described as an acne mRNA vaccine.
How does MRT1800 work?
The registered trial does not describe the molecular target or mechanism of action of MRT1800 in detail. As an mRNA vaccine, it is expected to deliver messenger RNA into cells so that the body produces a specific protein, which then triggers an immune response. The trial measures immunogenicity, suggesting that the immune response is an important part of how the vaccine is being evaluated.
Which conditions is it studied for?
- Moderate to severe acne — a common skin condition with inflamed spots and lesions on the face. The trial focuses on adults with this condition and measures changes in inflammatory and non-inflammatory acne lesions on the face.
How is MRT1800 given?
MRT1800 is given by intramuscular injection. The trial also uses a diluent, 0.9% sodium chloride solution, which is a sterile salt solution used to prepare the vaccine for injection.
What do the clinical trials show?
One clinical trial is registered for MRT1800. It is a Phase 1/2 study, which means it combines the early testing of safety in a small group with a larger evaluation of efficacy. The trial is authorised to enrol 549 adults with moderate to severe acne. The study is currently authorised, meaning it has received regulatory approval to proceed but is not yet recruiting participants.
The trial is divided into sentinel cohorts and main cohorts. The sentinel cohorts focus on safety, while the main cohorts evaluate efficacy. The primary efficacy measure is the percentage change from baseline in the number of inflammatory acne lesions on the face. The study also measures changes in non-inflammatory lesions and the total number of acne lesions on the face. Safety is assessed through the number of participants with solicited injection site and systemic reactions, unsolicited adverse events, medically attended adverse events (MAAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and out-of-range biological test results.
The trial includes a long-term extension phase to assess the long-term safety profile of the vaccine, specifically the number of participants with SAEs and AESIs.
What side effects are known?
No side effects have been reported for MRT1800 in the registry data. The trial is designed to collect information on side effects, including injection site reactions, systemic reactions, and serious adverse events, but no results are available yet.