The organisations Takeda Pharmaceutical Company and Ovid Therapeutics are collaborating over the development of the experimental drug TAK-935/OV935 as a possible treatment for several rare epilepsy syndromes. Takeda has just announced their plans for a clinical development program that includes three new studies. The original news release can be read here, at Takeda’s website.
The Three Announced Studies
Takeda has announced plans to carry out three more clinical trials of the experimental drug TAK-935/OV935. These are:
- A trial of the drug in paediatric patients who have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome
- A study of the effects of the drug on Duplication 15q syndrome (Dup15q) and CDKL5 deficiency disorder (CDD) in paediatric patients
- An extension trial of the drug in patients who have developmental and epileptic encephalopathies (DDEs), and who took part in a previous trial of the drug.
TAK-935/OV935 is also currently being investigated in a Phase 1b/2a clinical trial.
The Ongoing Study
This Phase 1b/2a study has finished enrolling patients diagnosed with rare DEEs. It is a dose-escalation study that will compare the effects of TAK-935/OV935 to a placebo. The researchers will look at how safe and tolerable the experimental drug is, as well as the effect it has on the frequency of patients’ seizures, and the levels of a molecule called 24HC. Topline results from the study are expected to be released around the end (fourth quarter) of 2018.
Previous Research into TAK-935/OV935
So far, four Phase 1 clinical trials of TAK-935/OV935 have already been carried out and completed. Preclinical research using models has also been used to investigate the effects of the experimental drug.
About the Rare DDEs
The conditions that the drug will be tested on in the upcoming clinical trials are Dravet syndrome and Lennox-Gastaut syndrome, and CDD and Dup15q.
Dravet syndrome causes severe childhood epilepsy that affects children’s intellectual development. It is usually a genetic condition that generally begins to affect children within their first year.
Lennox-Gastaut syndrome is a type of developmental and epileptic encephalopathy, that, according to the source article, is the cause of around 1 – 4% of childhood epilepsy.
Cyclin-dependent kinase-like 5 deficiency disorder (CDD) is a very rare and severe neurological condition. It is the result of a genetic alteration in the CDKL5 gene that affects the production of a protein involved in the development of the brain and neurones. CDD is linked to many effects, including developmental delays, intellectual disability, reduced fine motor skills, and epilepsy that is often treatment-resistant in very young infants.
Duplication 15q syndrome (Dup15q) is a severe neurological disorder that often leads to seizures, muscle issues, intellectual disability, and developmental delay.