Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAD: WVE-003 · 1 trial · 1 indication
The primary outcome for this study was safety and is reported as the proportion of patients with TEAEs related to study drug.
| Arm | Type | Description |
|---|---|---|
| SAD: Pooled Placebo | PLACEBO_COMPARATOR | Placebo |
| SAD: 30mg WVE-003 | EXPERIMENTAL | Single Ascending Dose - 30mg WVE-003 |
| SAD: 60mg WVE-003 | EXPERIMENTAL | Single Ascending Dose - 60mg WVE-003 |
| SAD: 90mg WVE-003 | EXPERIMENTAL | Single Ascending Dose - 90mg WVE-003 |
| MD: Placebo | PLACEBO_COMPARATOR | Placebo |
| MD: 30mg WVE-003 | EXPERIMENTAL | Multiple Dose - 30mg WVE-003 |
| Name | Type | Description |
|---|---|---|
| SAD: 30mg WVE-003 | DRUG | Single ascending dose of 30mg WVE-003, an allele-selective stereopure antisense oligonucleotide (ASO) |
| SAD: 60mg WVE-003 | DRUG | Single ascending dose of 60mg WVE-003, an allele-selective stereopure antisense oligonucleotide (ASO) |
| SAD: 90mg WVE-003 | DRUG | Single ascending dose of 90mg WVE-003, an allele-selective stereopure antisense oligonucleotide (ASO) |
| SAD: Pooled Placebo | DRUG | Single dose of placebo |
| MD: 30mg WVE-003 | DRUG | Three doses of 30mg WVE-003 Q8WK an allele-selective stereopure, antisense oligonucleotide (ASO) |
| MD: Placebo | DRUG | Three doses of placebo Q8WK |
Inclusion Criteria: 1. Presence of the A variant of SNP3 on the same allele as the pathogenic CAG triplet expansion 2. Ambulatory, male or female patients aged ≥25 to ≤60 years 3. Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Votoplam |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE3 | Valbenazine |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE1 | ALN-HTT02 |
| uniQure N.V. | QURE | 2 | PHASE1 | intra-striatal rAAV5-miHTT |
| Sarepta Therapeutics, Inc. | SRPT | 1 | PHASE1 | SRP-1005 |
WVE-003 is an investigational small molecule being developed for the treatment of Huntington Disease. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with Huntington Disease to evaluate its safety and efficacy.
WVE-003 is being developed by Wave Life Sciences Ltd., a biopharmaceutical company traded on the stock exchange under the ticker symbol WVE. The company is conducting clinical research on this investigational drug for Huntington Disease.
WVE-003 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 study has been completed, and the drug remains in early-stage clinical testing for Huntington Disease.
WVE-003 has been studied in a Phase 1 clinical trial with the identifier NCT05032196, titled "Study of WVE-003 in Patients With Huntington's Disease." This trial enrolled 47 participants and was conducted across multiple countries including Australia, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, and the United Kingdom.
Yes, the Phase 1 clinical trial of WVE-003 was a randomized, double-blind, placebo-controlled study. This design helps to assess the drug's effects compared to a placebo in patients with Huntington Disease, providing valuable data on its safety and potential efficacy.