Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORG101- Experimental 1 · 1 trial · 2 indications
Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo
Incidence of AEs and SAEs
Number of participants with AEs or SAEs as assessed by physical examination, vital signs, local skin responses, as assessed by treatment arm (vaccine and placebo)
Clinically significant change from the baseline in laboratory data as compared to placebo
Clinically significant change from the baseline in vital signs as compared to placebo
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Clinically significant change from the baseline in physical examination, as compared to placebo
| Arm | Type | Description |
|---|---|---|
| Experimental 1 | EXPERIMENTAL | C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m. |
| Placebo 1 | PLACEBO_COMPARATOR | Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections |
| Name | Type | Description |
|---|---|---|
| ORG101 - Experimental 1 | DRUG | C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals |
| ORG101PL - Placebo 1 | DRUG | Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals |
Inclusion Criteria: - Male or female subject aged ≥18 years at the time of informed consent signature * Female subjects of childbearing potential must have a negative serum or urine pregnancy test at Screening and before vaccination and must be willing to practice a highly effective method of contr...
ORG101 - Experimental 1 is an investigational small molecule developed by Sanofi for the treatment of acne vulgaris, a common inflammatory skin condition. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not an approved therapy.
ORG101 - Experimental 1 is being developed for acne vulgaris, also known as acne. The only completed clinical trial of the drug enrolled participants with acne vulgaris and acne in Germany. It has not been approved for any use and remains an investigational treatment in Phase 1 development.
ORG101 - Experimental 1 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the Phase 1 trial evaluating the drug in acne vulgaris.
ORG101 - Experimental 1 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of acne vulgaris.
ORG101 - Experimental 1 has been evaluated in one completed Phase 1 trial, NCT05131373, titled Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris. The trial enrolled 38 participants in Germany, was randomized, double blind, and placebo controlled, and included adults 18 years and older.
Yes, ORG101 - Experimental 1 is also known as ORG101. Both names refer to the same Sanofi investigational small molecule being studied in Phase 1 for acne vulgaris. Searches for either name point to the same drug candidate and the same completed trial, NCT05131373.