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HP-802-247 · 1 trial · 1 indication
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
| Arm | Type | Description |
|---|---|---|
| HP802-247 | EXPERIMENTAL | HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. |
| Vehicle | PLACEBO_COMPARATOR | Vehicle Control (fibrinogen solution \& thrombin solution without cells) |
| Name | Type | Description |
|---|---|---|
| HP-802-247 | BIOLOGICAL | HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. |
| Vehicle | BIOLOGICAL | (fibrinogen solution \& thrombin solution without cells) |
Inclusion Criteria: * Provide informed consent. * Age ≥ 18 years and of either sex. * Willing to comply with protocol instructions, including allowing all study assessments. * Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 1...
HP-802-247 is an investigational therapy being studied for the treatment of venous leg ulcers, a type of chronic wound. It is in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial to assess its safety and efficacy.
HP-802-247 is being developed by Smith & Nephew SNATS, Inc., a subsidiary of Smith & Nephew plc, which trades on the New York Stock Exchange under the ticker SNN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for venous leg ulcers.
HP-802-247 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the drug remains under investigation for the treatment of venous leg ulcers.
HP-802-247 has one completed Phase 3 clinical trial registered as NCT01656889, titled 'Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers.' The trial enrolled 447 participants in the United States and Canada and was randomized, double-blind, and placebo-controlled.
No alternative names for HP-802-247 have been disclosed. It is a distinct investigational drug being developed by Smith & Nephew SNATS, Inc. for venous leg ulcers. The drug is a monoclonal antibody, though its specific molecular target has not been publicly detailed in the available information.