PRECISION-HD2
SAFETY AND TOLERABILITY OF WVE-120102 IN PATIENTS WITH HUNTINGTON’S DISEASE
Terminated
ABOUT
SPONSOR
Wave Life Sciences Ltd.
PARTICIPANTS
60
Estimated Study Completion Date: December 2020
Ages Eligible for Study:
25 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria
- Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
- Ambulatory, male or female patients aged ≥25 – ≤65 years
- Clinical diagnostic motor features of HD, defined as Unified Huntington’s Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
- Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13
Exclusion Criteria
- Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years
- Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 halflives of the oligonucleotide, whichever is longer
- Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy
- Inability to undergo brain MRI
- Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
COUNTRIES
UPDATE
WAVE Life Sciences expects to report data from both its ongoing PRECISION-HD phase 1b/2a trials, and available data from the related OLE studies this spring. The analysis will include biomarker and safety data from all dosing cohorts up to and including the 32mg cohort for PRECISION-HD2 and completed dosing cohorts for PRECISION-HD1 (including all participants from the 16mg cohort). These data are expected to support a decision regarding a potential phase 3 study.
Participants from the phase 1b/2a trials have been enrolling into the OLE studies since 2020, and the vast majority of eligible patients have been enrolled. In December 2020, WAVE submitted a clinical trial application for WVE-003 (SNP3). This is WAVE’s first HD candidate to use its novel PN backbone chemistry modifications which, according to preclinical data, increase the potency, exposure and durability of a compound. WVE-003 is also designed to selectively target the mutant huntingtin mRNA transcript while leaving the wild-type protein relatively intact.
The protocol was also submitted to EHDN, which endorsed it in December 2020. WAVE expects to start dosing HD participants with SNP3 this year, once regulatory and ethical approvals are in place.
DENMARK
TRIAL SITE:
University Hospital of Aarhus
Address: Aarhus, Denmark
TRIAL SITE:
Rigshospitalet
Address: Copenhagen, Denmark
TRIAL SITE:
Odense University Hospital and University of Southern Denmark
Address: Odense, Denmark
FRANCE
TRIAL SITE:
Hospital Henri Mondor
Address: Créteil, France
TRIAL SITE:
Institut du Cerveau et de la Moelle Epinière
Address: Paris, France
GERMANY
TRIAL SITE:
George-Huntington- Institut GmbH
Address: Münster, Germany
POLAND
TRIAL SITE:
Szpital Sw. Wojciecha
Address: Gdańsk, Poland
TRIAL SITE:
Instytut Psychiatrii i Neurologii
Address: Warsaw, Poland
UNITED KINGDOM
TRIAL SITE:
Royal Devon and Exeter Hospital NHS Trust
Address: Exeter, Devon, United Kingdom
TRIAL SITE:
Queen Elizabeth University Hospital – PPDS
Address: Glasgow, United Kingdom
