Articles with the topic: clinical-trial

Moving into the Fast Lane: uniQure and the FDA Are on the Same Track for Accelerated Approval

Moving into the Fast Lane: uniQure and the FDA Are on the Same Track for Accelerated Approval

In an update shared today, uniQure announced alignment with the US drug regulator on key criteria for accelerated approval of drugs for Huntington’s disease.

Dr Rachel Harding and Dr Sarah HernandezDecember 10, 2024

Interim update from Vico Therapeutics on their CAG-targeting drug, VO659

Interim update from Vico Therapeutics on their CAG-targeting drug, VO659

Vico Therapeutics have shared interim data about their drug, VO659, which targets the CAG expansion that causes several genetic diseases, including #Huntingtonsdisease and #spinocerebellarataxia

Dr Rachel HardingDecember 10, 2024

Going boldly: First person treated in Phase 1 clinical trial by Alnylam Pharmaceuticals

Going boldly: First person treated in Phase 1 clinical trial by Alnylam Pharmaceuticals

A new Phase 1 clinical trial for the huntingtin-lowering drug ALN-HTT02 was initiated this week with the first dose given. Read on to learn details about the trial and how it compares to other ongoing huntingtin-lowering trials in the clinic.

Dr Sarah HernandezDecember 08, 2024

The dust has settled: Sage’s dalzanemdor won’t advance for cognitive impairment

The dust has settled: Sage’s dalzanemdor won’t advance for cognitive impairment

Changes in thinking, learning, and memory are some of the most distressing and impactful in Huntington’s disease. Sage Therapeutics was advancing their drug dalzanemdor to treat these symptoms, but unfortunately this program will be halted.

Dr Sarah HernandezNovember 20, 2024

Bringing HD Treatments to Market: The Role of Regulatory Oversight

Bringing HD Treatments to Market: The Role of Regulatory Oversight

Moving drugs from the lab bench to pharmacy shelves is no small task. In this article we delve into the role regulatory oversight plays in clinical trials and the approval of medicines for Huntington’s disease.

Dr Rachel HardingOctober 21, 2024

Hope vs. hype: seeking truth in recent Prilenia headlines

Hope vs. hype: seeking truth in recent Prilenia headlines

Although pridopidine has suffered four negative trials for HD, the message from Prilenia continues to be positive. What is hope and what is hype in this sixteen-year quest for regulatory approval?

Dr Sarah HernandezSeptember 10, 2024

Buckle in: Gene therapy AMT-130 appears to slow down signs of Huntington’s disease in Phase I/II clinical trial

Buckle in: Gene therapy AMT-130 appears to slow down signs of Huntington’s disease in Phase I/II clinical trial

More good news for the HD community from uniQure, whose one-and-done gene therapy appears safe and shows hints of slowing down signs and symptoms of the disease

Dr Rachel HardingAugust 16, 2024

Blue skies for Skyhawk: Positive news from Phase 1 trial for SKY-0515

Blue skies for Skyhawk: Positive news from Phase 1 trial for SKY-0515

There’s more good news in the forecast in the Huntington’s disease therapeutic space as we receive positive results from Skyhawk Therapeutics about their small molecule SKY-0515 that lowers huntingtin and targets somatic expansion.

Dr Sarah HernandezJuly 11, 2024

Positive news from Wave Life Sciences SELECT-HD trial

Positive news from Wave Life Sciences SELECT-HD trial

The outcomes of the SELECT-HD clinical trial are out, with encouraging news for this allele-selective huntingtin lowering therapy

Dr Rachel HardingJune 28, 2024

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