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DX-2930 · 4 trials · 1 indication
An adverse event (AE) was any untoward medical occurrence in a clinical trial Participant whether or not it appeared to have a causal relationship with the treatment administered. Treatment-emergent AEs were defined as AEs with onset at the time of or following the first exposure to open-label DX-2930 in this study, or medical conditions present prior to the start of treatment but increasing in severity or relationship at the time of or following the start of treatment.
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
A SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes: Death, Life-threatening experience, required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant disability or incapacity. Was a congenital anomaly or birth defect. Was considered to be an important medical event. An AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.
| Arm | Type | Description |
|---|---|---|
| Rollover Participants | EXPERIMENTAL | Participants who rollover from the DX-2930-03 study will receive 300 milligram (mg) DX-2930 subcutaneous injection at Day 0 followed by second dose following the first HAE attack and then once in every 2 weeks until the end of the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days is required between subsequent administrations. |
| Non-rollover Participants | EXPERIMENTAL | Participants who were not participants in DX-2930-03 will receive 300 milligram (mg) DX-2930 subcutaneous injection once in every 2 weeks until the end of the treatment period (up to 924 days). |
| DX-2930 300 mg every 2 weeks | EXPERIMENTAL | 300 mg DX-2930 administered every 2 weeks by subcutaneous injection. |
| DX-2930 300 mg every 4 weeks | EXPERIMENTAL | 300 mg DX-2930 administered every 4 weeks by subcutaneous injection |
| DX-2930 150 mg every 4 weeks | EXPERIMENTAL | 150 mg DX-2930 administered every 4 weeks by subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo administered every 2 weeks by subcutaneous injection. |
| DX-2930, Cohort 1 | EXPERIMENTAL | Participants will receive 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
| DX-2930, Cohort 2 | EXPERIMENTAL | Participants will receive 100 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm. |
| DX-2930, Cohort 3 | EXPERIMENTAL | Participants will receive 300 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm. |
| DX-2930, Cohort 4 | EXPERIMENTAL | Participants will receive 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
| DX-2930 | EXPERIMENTAL | DX-2930 administered by subcutaneous route |
| Name | Type | Description |
|---|---|---|
| DX-2930 | DRUG | Participants who rollover from the DX-2930-03 study will receive 300 milligram (mg) DX-2930 subcutaneous injection at Day 0 followed by second dose following the first HAE attack and then once in every 2 weeks until the end of the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days is required between subsequent administrations. |
| DX-2930 - 300mg/2wk | DRUG | 300 mg DX-2930 administered every 2 weeks by subcutaneous injection. |
| DX-2930 - 300mg/4wk | DRUG | 300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug. |
| DX-2930 - 150mg/4wk | DRUG | 150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug. |
| Placebo | DRUG | Placebo administered every 2 weeks by subcutaneous injection. |
Inclusion Criteria: * Male and female HAE participants who are 12 years of age or older at the time of screening * Documented diagnosis of HAE (Type I or II) based on 1. Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying u...
| 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 |
DX-2930 is an investigational small molecule being developed for the prevention of acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE). It is currently in Phase 3 clinical development and has not been approved by the FDA.
DX-2930 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is in Phase 3 clinical development for the prevention of acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema.
DX-2930 is in Phase 3 clinical development. It has completed four clinical trials, including two Phase 1 studies and two Phase 3 studies, all of which are completed. The drug is investigational and has not been approved by the FDA.
DX-2930 has completed four clinical trials: NCT01923207, a Phase 1 single ascending dose study in healthy subjects; NCT02093923, a Phase 1 multiple ascending dose study in HAE patients; NCT02586805, a Phase 3 efficacy and safety study; and NCT02741596, a Phase 3 long-term safety and efficacy study.
Yes, DX-2930 is also known as SHP643. The long-term safety and efficacy study NCT02741596 refers to the drug as DX-2930 (SHP643), indicating that both names refer to the same investigational drug for preventing acute angioedema attacks in Hereditary Angioedema.