Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP640 · 1 trial · 1 indication
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
| Arm | Type | Description |
|---|---|---|
| SHP640 | EXPERIMENTAL | Participants will instill 1 drop of SHP640 (povidone-iodine \[PVP-I\] 0.6 percent \[%\] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. |
| PVP-I 0.6% | ACTIVE_COMPARATOR | Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days |
| Placebo | PLACEBO_COMPARATOR | Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days. |
| Name | Type | Description |
|---|---|---|
| SHP640 | DRUG | Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days. |
| PVP-I 0.6% | DRUG | Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days. |
| Placebo | DRUG | Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days. |
Inclusion Criteria: * An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable). * Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guar...
SHP640 is an investigational small molecule being developed for the treatment of bacterial conjunctivitis, an infection of the eye. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied as a potential therapy for this infectious disease condition.
SHP640 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is publicly traded on the Tokyo Stock Exchange and the New York Stock Exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of SHP640 for bacterial conjunctivitis.
SHP640 is in Phase 3 clinical development for bacterial conjunctivitis. It is an investigational drug that has not yet received regulatory approval. The Phase 3 trial has been completed, and the drug remains under clinical investigation. SHP640 is not approved for commercial use at this time.
SHP640 has been studied in one completed Phase 3 clinical trial, identified as NCT03004924. This randomized, double-blind, placebo-controlled trial enrolled 753 participants with bacterial conjunctivitis across multiple countries, including the United States, Australia, Austria, Canada, Estonia, France, Hungary, Israel, Italy, Poland, Puerto Rico, South Africa, and Spain.
No, SHP640 is not the same as PVP-iodine. In the clinical trial NCT03004924, SHP640 was compared to PVP-iodine and placebo as separate treatment arms. SHP640 is the investigational drug being evaluated, while PVP-iodine served as an active comparator in the study. The trial was designed to assess the efficacy and safety of SHP640 relative to these comparators.