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
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
- 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
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/16/2023 05:15:10 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/15/2023 09:11:14 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 11/03/2023 08:08:37 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/03/2023 12:13:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/03/2023 12:10:27 PM
- Ovid Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Updates • GlobeNewswire Inc. • 11/03/2023 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/18/2023 12:04:53 PM
- Ovid Therapeutics and Ligand Pharmaceuticals Enter into a $30 Million Agreement for a 13% Interest in Soticlestat Royalties and Milestones Extending Ovid’s Cash Runway into 2026 • GlobeNewswire Inc. • 10/18/2023 12:00:00 PM
- Ovid Therapeutics to Present at the Jefferies Biotech CNS/Neuro Summit • GlobeNewswire Inc. • 10/10/2023 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/02/2023 04:15:27 PM
FEATURED Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • May 7, 2024 8:51 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM