Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SUM-191 · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
The severity (or intensity) of an AE refers to the extent to which it affects the participant's daily activities and will be classified as mild, moderate, or severe using the following criteria: * Mild: These events require minimal or no treatment and do not interfere with the participant's daily activities. * Moderate: These events result in a low level of inconvenience or require minor therapeutic measures. Moderate events may cause some interference with normal functioning. * Severe: These events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating.
Clinical cure rate (% of participants with bulbar conjunctival injection and mucopurulent discharge score are zero)
| Arm | Type | Description |
|---|---|---|
| SUM-191 | EXPERIMENTAL | Participants will receive SUM-191. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo |
| Name | Type | Description |
|---|---|---|
| SUM-191 | DRUG | Part 1 (SAD): SUM-191 is administrated a single dose topically. Part 2 (MAD): SUM-191 is administrated TID topically for 6 days. Part 3: SUM-191 is administrated TID topically for 6 days. |
| Placebo | DRUG | Part 1 (SAD): Placebo is administrated a single dose topically. Part 2 (MAD): Placebo is administrated TID topically for 6 days. Part 3: Placebo is administrated TID topically for 6 days. |
Inclusion Criteria: 1. The participant is able to provide signed and dated, written informed consent prior to any trial specific procedures. 2. The participant understands and is able and willing to fully comply with trial procedures and restrictions. 3. The participant is a male or non-pregnant, n...
SUM-191 is an investigational small molecule being developed for the treatment of bacterial conjunctivitis, a common eye infection. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in a randomized, double-blind, placebo-controlled trial to evaluate its safety and efficacy.
SUM-191 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting a Phase 1 clinical trial of SUM-191 in the United States for the treatment of bacterial conjunctivitis.
SUM-191 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants and is designed to assess the safety and efficacy of SUM-191 in patients with bacterial conjunctivitis.
SUM-191 is being studied in a Phase 1 clinical trial with the identifier NCT07565103, titled 'Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis.' The trial is recruiting in the United States, with an enrollment target of 426 participants aged 18 years and older.
SUM-191 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for bacterial conjunctivitis. The ongoing study is a randomized, double-blind, placebo-controlled trial that includes healthy volunteers, and its results will determine whether further clinical development is warranted.