Ovid Therapeutics Inc (NASDAQ:OVID) recently announced the results of its ARCADE and ENDYMION studies evaluating its pipeline drug soticlestat as a potential therapy for epileptic encephalopathies (DEEs).
The company conducted the ARCADE phase 2 study as an open-label signal-finding pilot study evaluating patients that have rare epilepsies called Dup15q syndrome (Dup15q) and CDKL5 deficiency disorder (CDD). The latter two are highly refractory and they do not have any approved therapies so far. The ENDYMION study features a long-term open-label extension study evaluating soticlestat. All the patients that went through the ARCADE study were enrolled in the ENDYMION study.
Ovid developed soticlestat as an inhibitor of the cholesterol 24-hydroxylase (CH24H) enzyme and the development process was in partnership with Takeda Pharmaceutical Co Ltd (NYSE: TAK). The participants in the study have been receiving soticlestat orally. The data collected from the ENDYMION and ARCADE study showed that the patients experienced fewer seizures over time.
Soticlestat has so far maintained a strong safety and efficacy profile
CDD patients that went through long-term treatment for 9 months in the ENDYMION experienced a 50 percent reduction in seizure frequency. However, patients that were in the ARCADE study experienced a median increase in seizure frequency in the 12th week, although the full 9-month data revealed a 74 percent reduction.
As far as soticlestat’s safety profile is concerned, there were no adverse effects and the treatment was well tolerated in the two studies. The drug has so far demonstrated consistency considering that the results of the ENDYMION and ARCADE studies were just as favorable as previous studies involving soticlestat.
“CDD and Dup15q patients have various seizure types and are on multiple concomitant antiseizure medications per current medical practice, and yet they still lack significant control of their respective seizures,” stated Ovid Therapeutics’ Chief Medical officer, Dr. Amit Rakhit.
Soticlestat’s rollout into the market will be a huge step in the right direction especially for patients with severe epilepsy. Anti-seizure drugs have a bad reputation for becoming less efficient in the long-run because they lose their efficacy. Soticlestat’s ability to deliver long-term anti-seizure effects makes it an appealing option for epilepsy patients.