![](https://investorshub.advfn.com/uicon/58431.png?cb=1505481885)
Tuesday, October 29, 2019 4:59:59 PM
Soticlestat Shows Promise for Developmental Epileptic Encephalopathies
The director of pediatric epilepsy at Northeast Regional Epilepsy Group and co-director of epileptology at Hackensack University Medical Center spoke about soticlestat and what can be gleaned from data thus far.
By: Matt Hoffman
Published: October 17, 2019
![](http://neurologylive.s3.amazonaws.com/_media/_image/_headshots/Eric-Segal.png)
Dr Eric SegalEric Segal, MDRecently, Ovid Therapeutics announced that its phase 2 open-label extension study of soticlestat produced initial positive results, with data suggesting that the therapy is effective over the long-term in treating patients with rare developmental epileptic encephalopathies.
Ultimately, the highly selective first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) was associated with seizure reduction over 48 weeks in a small cohort of 7 patients. The median seizure frequency reductions were 84% after 25 to 36 weeks (n = 6) and 90% after 37 to 48 weeks (n = 4) of treatment, with 2 patients experiencing seizure-free runs of 264 and 150 consecutive days, respectively. Additionally, the safety and tolerability of soticlestat, previously known as OV935/TAK935, was consistent with the observations from the phase 1b/2a trial.
Amit Rakhit, MD, MBA, Chief Medical Officer, Head of Research & Development, Ovid, said in a statement that the clinical development program of soticlestat in developmental epileptic encephalopathies is expected to read out data from the ARCADE and ELEKTRA studies in 2020.
To learn more about soticlestat and the latest data, NeurologyLive spoke with Eric Segal, MD, director, pediatric epilepsy, Northeast Regional Epilepsy Group, co-director, epileptology, Hackensack Meridian Health, and assistant professor of pediatrics and neurology, Hackensack Meridian School of Medicine. Segal, a trial investigator for soticlestat, provided insight into the clinical takeaways and the potential of the therapy.
NeurologyLive: What does the clinician community need to know about these data and about soticlestat in general?
Eric Segal, MD: The preliminary data that we've seen thus far is very exciting for a first-in-class mechanism. We have pretty significant positive efficacy results in a small group of adult patients who typically have pretty severe epilepsies and it was well tolerated. I think all those pieces are very interesting.
Obviously, we need to see how this therapy works in larger groups of patients. That's going to be the next big thing. What I found to be the most interesting about the data was not only the significant median seizure reduction but also how seizure reduction was sustained and improved the longer the patients took on the medication. A lot of times when we look at open-label extensions, we tend to see a significant drop out in the number of patients. There's a small number of patients to start with, but the majority of those patients stayed in the study and had improvements in seizure frequency going from week 1 through week 36. That is very unique.
Are there any other specific datapoints that make this therapy stand out or make this therapy unique in this space?
There are a few things. One is that the sustained efficacy in this group of patients is significant. Especially in a group of patients with epileptic encephalopathies who tend to try or have used, and unfortunately have failed, some of our most effective medications that are available. To have such a high seizure reduction rate that is sustained in a group of people that have failed what we would think of as our strongest or most efficacious medications, I think that is very significant.
Is there a particular rare epilepsy or subgroup in which soticlestat has significant potential?
The therapy is underway in study for Lennox-Gastaut syndrome and Dravet syndrome. I would say that a lot of these rare disorders can be very difficult to treat in clinical practice. I think for most clinicians, of the potential indicated epilepsies, Lennox-Gastaut syndrome is probably going to be where you find the greatest number of patients with a great need, and it's exciting to see that this therapy is being considered for that. I'm really interested in seeing that in all the genetic epilepsies that that's being tested in. But especially in Lennox-Gastaut, given that we have such a large LGS community of patients that definitely need better therapies than are what are currently available.
Transcript edited for clarity.
https://www.neurologylive.com/clinical-focus/soticlestat-shows-promise-for-developmental-epileptic-encephalopathies
Recent OVID News
- eNeuro Publishes Findings on the Anti-Convulsant Properties of OV329 and Its Potential Effectiveness in Treatment-Resistant Seizures • GlobeNewswire Inc. • 07/10/2024 12:00:00 PM
- Ovid Therapeutics and Graviton Bioscience Announce Topline Data from a Phase 1 Clinical Trial Studying OV888/GV101 Capsule, a Potential First-In-Class Therapy for Cerebral Cavernous Malformations • GlobeNewswire Inc. • 07/01/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/17/2024 11:10:10 AM
- Ovid Therapeutics Reports on Takeda’s Announcement of Phase 3 Topline Study Results for Soticlestat • GlobeNewswire Inc. • 06/17/2024 10:55:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:22:06 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/14/2024 09:19:51 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 12:11:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 12:03:02 PM
- Ovid Therapeutics Reports Business Updates and First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/14/2024 12:00:00 PM
- Ovid Therapeutics to Present at the H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/13/2024 11:00:00 AM
- Ovid Therapeutics to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/04/2024 12:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/08/2024 01:24:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/08/2024 01:20:05 PM
- Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/08/2024 01:00:00 PM
- Ovid Therapeutics to Present at the TD Cowen 44th Annual Health Care Conference • GlobeNewswire Inc. • 02/28/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 11:05:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 11:01:37 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 11:00:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 10:56:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 10:53:07 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 04:10:32 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 11:06:38 AM
- Ovid Therapeutics to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference • GlobeNewswire Inc. • 02/06/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/06/2023 10:08:19 PM
- Ovid Therapeutics to Present Five Abstracts Supporting its Epilepsy Programs at the 77th American Epilepsy Society Annual Meeting (2023) • GlobeNewswire Inc. • 12/01/2023 12:30:00 PM
Peer To Peer Network aka Mobicard™ Launches AI Investor Chatbot Boosting Engagement & Lead Generation on Ihub • PTOP • Jul 15, 2024 8:30 AM
Greenlite Ventures Announces AI Integration into No Limit Platforms • GRNL • Jul 15, 2024 8:00 AM
Cannabix Technologies and Omega Laboratories Inc. Provide Positive Developments on Marijuana Breathalyzer Testing • BLO • Jul 11, 2024 8:21 AM
ECGI Holdings Enhances Board with Artificial Intelligence (AI) Expert Ahead of Allon Apparel Launch • ECGI • Jul 10, 2024 8:30 AM
Avant Technologies to Meet Unmet Needs in AI Industry While Addressing Sustainability Concerns • AVAI • Jul 10, 2024 8:00 AM
Panther Minerals Inc. Launches Investor Connect AI Chatbot for Enhanced Investor Engagement and Lead Generation • PURR • Jul 9, 2024 9:00 AM