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ML Risk
HGT-1110 · 1 trial · 1 indication
An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational drug product-related. TEAEs are defined as all AEs occurring or worsening at or after the first dose of investigational drug product in HGT-MLD-071 or ongoing from HGT-MLD-070 at the time of enrollment into HGT-MLD-071.
The presence of anti-HGT-1110 antibodies in CSF and serum will be assessed.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will receive 10 milligram (mg) of HGT-1110 (Recombinant human arylsulfatase A) intrathecal (IT) injection every-other-week (EOW). |
| Cohort 2 | EXPERIMENTAL | Participants will receive 30 mg of HGT-1110 IT injection EOW. |
| Cohort 3 | EXPERIMENTAL | Participants will receive 100 mg of HGT-1110 IT injection EOW. |
| Cohort 4 | EXPERIMENTAL | Participants will receive 100 mg of HGT-1110 IT injection once weekly for 12 weeks followed by 150 mg EOW. |
| Name | Type | Description |
|---|---|---|
| HGT-1110 | BIOLOGICAL | Participants will receive IT injection of HGT-1110. |
Inclusion Criteria: 1. Participant has participated in Study HGT-MLD-070 (NCT01510028) through Week 40. 2. Participant must have no safety or medical issues that contraindicate participation. 3. The participant, participant's parent(s), or legally authorized representative(s) must provide written i...
HGT-1110 is an investigational monoclonal antibody being studied for the treatment of Metachromatic Leukodystrophy (MLD), a rare genetic disorder. It is currently in Phase 1 clinical development and is not yet approved for use.
HGT-1110 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for Metachromatic Leukodystrophy.
HGT-1110 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to assess its safety and efficacy in participants with Metachromatic Leukodystrophy.
HGT-1110 has been studied in one clinical trial, identified as NCT01887938. This was a Phase 1, controlled study that has been completed, enrolling 24 participants with Metachromatic Leukodystrophy across multiple countries including Australia, Brazil, Czechia, Denmark, France, Germany, and Japan.
Yes, HGT-1110 is a monoclonal antibody. It is being investigated as a potential treatment for Metachromatic Leukodystrophy, a rare disease. The drug is currently in early-stage clinical development, with a completed Phase 1 trial.