Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acne mRNA vaccine · 2 trials · 1 indication
pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
Presence of all SAEs
Presence of out-of-range biological test results (including shift from baseline values)
Presence of all SAEs and AESIs
Presence of unsolicited systemic adverse events (AEs) reported
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Presence of medically attended adverse events (MAAEs)
Presence of all serious adverse events (SAEs)
Presence of AEs of special interest (AESIs)
Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
| Arm | Type | Description |
|---|---|---|
| Sentinel Cohort Arm 1 | EXPERIMENTAL | Participants will receive 2 Acne mRNA Vaccine injections |
| Sentinel Cohort Arm 2 | PLACEBO_COMPARATOR | Participants will receive 2 Placebo injections |
| Main Cohort Arm 1 | EXPERIMENTAL | Participants will receive 2 Acne mRNA Vaccine injections |
| Main Cohort Arm 2 | PLACEBO_COMPARATOR | Participants will receive 2 Placebo injections |
| Sentinel Cohort A - Experimental | EXPERIMENTAL | Two administrations of the Acne mRNA vaccine will be injected in three increasing doses |
| Sentinel Cohort A - Placebo | PLACEBO_COMPARATOR | Two administrations of placebo will be injected |
| Sentinel Cohort B - Experimental | EXPERIMENTAL | Three administrations of the Acne mRNA vaccine will be injected in two increasing doses |
| Sentinel Cohort B - Placebo | PLACEBO_COMPARATOR | Three administrations of placebo will be injected |
| Main Cohort A - Experimental | EXPERIMENTAL | Two administrations of the Acne mRNA vaccine will be injected in three increasing doses |
| Main Cohort A - Placebo | PLACEBO_COMPARATOR | Two administrations of placebo will be injected |
| Main Cohort B - Experimental | EXPERIMENTAL | Three administrations of the Acne mRNA vaccine will be injected in two increasing doses |
| Main Cohort B - Placebo | PLACEBO_COMPARATOR | Three administrations of placebo will be injected |
| Name | Type | Description |
|---|---|---|
| Acne mRNA vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection Route of administration: intramuscular |
| Placebo | OTHER | Pharmaceutical form: liquid solution for injection Route of administration: intramuscular |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator * Clinical diagnosis of mild facial acne vulgaris with: * IGA score of mild (grade 2 on the 5-grade I...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 1 | PHASE3 | Undisclosed |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | 1% Clascoterone |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE1 | Acne mRNA vaccine |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 2%, HT-001 1%, HT-001 0.5% |
| Sagimet Biosciences Inc. Class A | SGMT | 1 | PHASE1 | TVB-3567 |
| Bausch Health Companies Inc. | BHC | 1 | - | clindamycin , adapalene and benzoyl peroxide |
The Acne mRNA vaccine is an investigational vaccine being developed for acne. It is being studied in adults with moderate to severe acne and in participants with mild acne. The vaccine is in Phase 1 clinical development and is not yet approved by the FDA.
Sanofi (ticker: SNY) is developing the Acne mRNA vaccine. The company is conducting Phase 1 clinical trials to evaluate the vaccine's safety, efficacy, and immunogenicity in adults with acne.
The Acne mRNA vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. Two Phase 1 trials are currently recruiting participants to study the vaccine in adults with acne.
The Acne mRNA vaccine is being studied in two Phase 1 trials. NCT06316297 evaluates the vaccine in adults with moderate to severe acne, with an enrollment of 800 participants across the United States, Australia, Canada, and Puerto Rico. NCT07013747 evaluates the vaccine in participants with mild acne, with an enrollment of 228 participants in the United States.
The Acne mRNA vaccine is classified as a monoclonal antibody modality, though it is described as an mRNA vaccine. It is being developed by Sanofi for the treatment of acne. The vaccine is in Phase 1 clinical trials and is not yet approved.