Monday, 25 August 2014

Teva: putting its money where its mouth is

Laquinimod gets a vote of confidence as Teva take it into Huntington's disease. #MSBlog #MSResearch

"You have heard me get excited on this blog about the potential of laquinimod to be the ultimate add-on DMT for MS. Laquinimod appears to work downstream of the autoimmune inflammatory events and targets the so called glial, or innate immune, responses. In the RRMS trial programme laquinimod did not have a very striking effect on relapses, or focal MRI activity, but did delay MS disease progression and slowed down excessive brain atrophy in MSers. This is why Teva are now taking laquinimod forward in progressive MS in addition to another large trial in RRMS. However, the glial, or innate immune, response in MS, which I refer to as the 'Hot Microglial' response is not unique to MS and occurs in most neurodegenerative diseases. This is why I find the news that Teva are testing laquinimod in Huntington's disease, an hereditary neurodegenerative disease, so exciting. Teva obviously believe enough in the mode of action of laquinimod to tackle an orphan non-autoimmune neurodegenerative disease. This is what I call 'putting your money where your mouth is'. I can only complement Teva on not being risk adverse; great things come to people and organisations who take risks."


A Clinical Study in Subjects With Huntington's Disease to Assess the Efficacy and Safety of Three Oral Doses of Laquinimod

ClinicalTrials.gov Identifier: NCT02215616

Primary Outcome Measure: Change from baseline in Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS TMS)

Inclusion Criteria:
  1. Presence of 40-49 CAG repeats, inclusive, in the huntington gene
  2. Male or female between 21-55 years of age, inclusive, with an onset of HD at or after 18 years of age
  3. Women of child-bearing potential (women who are not post menopausal or who have undergone surgical sterilization) must practice an acceptable method of birth control for 30 days before taking the study treatment, and 2 acceptable methods of birth control during all study duration and until 30 days after the last dose of treatment was administered.
  4. A sum of >5 points on the UHDRS TMS at the screening visit
  5. Able and willing to provide written informed consent prior to any study related procedure being performed at the screening visit. Patients with a legal guardian should be consented according to local requirements
  6. Willing to provide a blood sample at the screening visit
  7. Willing and able to take oral medication and able to comply with the study specific procedures
  8. Ambulatory, being able to travel to the study centre, and judged by the investigator as likely to be able to continue to travel for the duration of the study
  9. Availability and willingness of a caregiver, informant, or family member to provide input at study visits. A caregiver is recommended to be someone who attends to the patient at least 2 to 3 times per week for at least 3 hours per occasion, and the suitability of the caregiver should be judged by the investigator
"For more information on HD I suggest reading this easy to understand post on NHS Choices."

CoI: multiple

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