Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RG6496 · 1 trial · 1 indication
A neurologic examination including fundoscopy, will be performed by a neurologist or an ophthalmologist depending on local practice. A neurologic examination will include an assessment of mental status, level of consciousness, cranial nerve function, motor function, sensory function, reflexes, gait, and coordination.
C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe.
MoCA is a rater-administered, participant completed assessment (PerfO instrument) used to detect cognitive impairment. It contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0 to 30, where lower scores indicate greater impairment.
A neurologic examination including fundoscopy, will be performed by a neurologist or an ophthalmologist depending on local practice. A neurologic examination will include an assessment of mental status, level of consciousness, cranial nerve function, motor function, sensory function, reflexes, gait, and coordination.
C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe.
MoCA is a rater-administered, participant completed assessment (PerfO instrument) used to detect cognitive impairment. It contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0 to 30, where lower scores indicate greater impairment.
| Arm | Type | Description |
|---|---|---|
| Part 1: RG6496 | EXPERIMENTAL | Participants will receive single dose of RG6496. Participants will be enrolled in planned sequential cohorts associated with ascending dose levels. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of RG6496 matching placebo. |
| Part 2: OLE | EXPERIMENTAL | All participants who have completed Part 1 and are eligible for Part 2 will receive one open-label dose of RG6496. |
| Name | Type | Description |
|---|---|---|
| RG6496 | DRUG | RG6496 will be administered as per the schedule specified in the respective arms. |
| Placebo | DRUG | RG6496 matching placebo will be administered as per the schedule specified in placebo arm. |
Inclusion Criteria: Part 1 * Confirmation of HDGEC status with cytosine-adenine-guanine (CAG) expansion \> 39. * Confirmation of SNP carrier status of the target SNP * Independence Scale (IS) score of ≥70, total functional capacity (TFC) ≥10, total motor score (TMS) \>6. * Ability to read the word...
| 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 |
RG6496 is an investigational small molecule being developed for the treatment of Huntington's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with this condition.
RG6496 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Huntington's Disease.
RG6496 is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of RG6496 in patients with Huntington's Disease.
RG6496 is being evaluated in a Phase 1 clinical trial registered as NCT07246941. This study is active but not recruiting participants and is assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of RG6496 in Huntington's Disease. The trial is randomized, double-blind, and placebo-controlled, with an enrollment of 3 participants.
RG6496 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Huntington's Disease. The drug has not yet completed the clinical trials necessary to establish its safety and efficacy for regulatory approval.