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ecallantide · 3 trials · 1 indication
Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.
The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.
Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement \[100\] to significant worsening \[-100\]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.
| Arm | Type | Description |
|---|---|---|
| DX-88 (ecallantide) | EXPERIMENTAL | DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose. |
| Placebo | PLACEBO_COMPARATOR | Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections. |
| Name | Type | Description |
|---|---|---|
| ecallantide | DRUG | solution for SC injection, one 30 mg dose per HAE attack |
| Phosphate Buffer Saline (PBS), pH 7.0 | DRUG | given as three 1mL subcutaneous injections. |
| Phosphate Buffer Saline (PBS), | DRUG | given as three 1mL subcutaneous injections. |
Inclusion Criteria: * 10 years of age or older * Documented diagnosis of HAE (Type I or II) * Willing and able to give informed consent * Acute HAE attack at time of presentation Exclusion Criteria: * Receipt of an investigational drug or device, within 30 days prior to study treatment, other tha...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002, Normal Saline Administration |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
Ecallantide is used for the treatment of acute attacks of Hereditary Angioedema (HAE), a rare genetic condition characterized by recurrent episodes of severe swelling. It is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited (TAK) and is currently in Phase 3 clinical development.
Ecallantide is a small molecule that targets the plasma kallikrein pathway, which plays a central role in the generation of bradykinin, a key mediator of swelling in Hereditary Angioedema. By inhibiting this pathway, ecallantide aims to reduce the severity and duration of acute HAE attacks.
Ecallantide is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol TAK. The drug is currently in Phase 3 clinical trials for the treatment of Hereditary Angioedema.
Ecallantide is in Phase 3 clinical development for the treatment of Hereditary Angioedema (HAE). It is an investigational drug and has not yet been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total of 334 patients enrolled across studies.
Ecallantide has completed three Phase 3 clinical trials: NCT00262080, NCT00456508, and NCT00457015. These randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of ecallantide in treating acute attacks of Hereditary Angioedema in patients aged 10 years and older across the United States, Canada, and Jordan.
Yes, ecallantide is also known as DX-88. The clinical trials NCT00262080, NCT00456508, and NCT00457015 refer to the drug as DX-88 (ecallantide) in their titles, confirming that these names refer to the same investigational therapy for Hereditary Angioedema.