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Also known as DX-88 (ecallantide), ecallantide
DX-88 · 4 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.
successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours
partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours
| 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. |
| 5mg/m2 DX-88 IV | EXPERIMENTAL | 5mg/m2 DX-88 (ecallantide)administered intravenously |
| 10mg/m2 DX-88 IV | EXPERIMENTAL | 10mg/m2 DX-88(ecallantide)administered intravenously |
| 20mg/m2 DX-88 IV | EXPERIMENTAL | 20mg/m2 DX-88 (ecallantide) administered intravenously |
| 30 mg DX-88 SC | EXPERIMENTAL | 30mg DX-88(ecallantide)administered subcutaneously |
| 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. |
| DX-88 (ecallantide) | DRUG | solution for injection 10 mg/mL |
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 |
| 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 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
DX-88 is being developed for the treatment of Hereditary Angioedema (HAE), a condition characterized by recurrent episodes of severe swelling. It is an investigational small molecule in the immunology therapeutic area. Its clinical evaluation has focused specifically on mitigating angioedema attacks in patients with HAE.
DX-88 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for the clinical program evaluating DX-88 in Hereditary Angioedema. The drug remains an investigational asset within the company's immunology pipeline.
DX-88 is in Phase 2 clinical development for Hereditary Angioedema. It has not been approved by the FDA and remains investigational. The Phase 2 program has been completed, and no trials are currently active. One Phase 2 trial has been conducted to date.
DX-88 has been evaluated in one completed Phase 2 trial, NCT01826916, titled EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema. The trial enrolled 77 participants with Hereditary Angioedema, included patients aged 10 years and older of all sexes, and used a controlled design. No trials are currently active.
Yes, DX-88 is also known as ecallantide. Both names refer to the same investigational small molecule being developed by Takeda for Hereditary Angioedema. Readers searching for either DX-88 or ecallantide are looking at the same drug asset and the same clinical development program.
A total of 77 patients have been enrolled in DX-88 clinical trials. That enrollment comes from the single completed Phase 2 study, NCT01826916, which evaluated DX-88 in Hereditary Angioedema. The trial was controlled but was not randomized and was not double blind.