Zogenix Presents New Data for FINTEPLA® in Dravet Syndrome at CNS 2020

Rhea-AI Summary

Zogenix, Inc. (Nasdaq: ZGNX) shared significant findings from an open-label extension trial of FINTEPLA® (fenfluramine) for Dravet syndrome at CNS/ICNA 2020. The interim data indicated that substantial seizure reductions were maintained for up to two years. A post-hoc analysis revealed favorable Number Needed to Treat (NNT) for achieving ≥75% seizure reduction compared to other therapies for Dravet syndrome. FINTEPLA is FDA-approved, under European review, and in development for Lennox-Gastaut syndrome treatment. These results underscore FINTEPLA's clinical value for patients and families affected by Dravet syndrome.

Positive

• Substantial seizure reductions maintained for up to two years in Dravet syndrome patients treated with FINTEPLA.
• Favorable post-hoc analysis showing improved NNT for achieving ≥75% seizure reduction compared to similar therapies.
• FINTEPLA is FDA-approved and under review in Europe, indicating strong regulatory support.

Negative

• None.

• Interim data from open-label extension trial showed substantial seizure reductions were maintained in patients treated with FINTEPLA® for up to two years

• Post-hoc analysis demonstrated NNTs (Number Needed to Treat) to achieve a clinically meaningful response compared favorably to similar studies of other Dravet syndrome therapies

EMERYVILLE, Calif., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq: ZGNX), a global biopharmaceutical company developing rare disease therapies, shared new data analyses for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome at the Child Neurology Society and International Child Neurology Congress (CNS/ICNA) 2020. Dravet syndrome is a rare, highly refractory form of infant- and childhood-onset epilepsy marked by frequent and often prolonged seizures that are difficult to control with existing medications, significant cognitive and motor impairments, and a higher risk of sudden death.

“In addition to the significant convulsive seizure reductions seen in all three multi-national Phase 3 studies of FINTEPLA in Dravet syndrome, we are proud to collaborate with expert clinician investigators to show the durability of the clinically meaningful seizure reduction that FINTEPLA provided for patients treated for up to two years,” said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. “Furthermore, new post-hoc data analysis from our studies demonstrated that for every two to three patients treated with FINTEPLA, one patient achieved ≥75% (profound) convulsive seizure reduction compared with placebo. We believe these new data analyses further showcase the clinical value that FINTEPLA provides for many Dravet syndrome patients and their families.”

The company’s CNS 2020 posters are now available in the Zogenix Newsroom and include:

• Long-Term (2-Year) Safety and Efficacy of Adjunctive ZX008 (Fenfluramine HCl) for Dravet Syndrome: Interim Results of an Ongoing Open-Label Extension Study
  (Sullivan, Auvin, Pringsheim et al)
  
  
• Number Needed to Treat (NNT) with Fenfluramine to Achieve a Clinically Meaningful Reduction in Convulsive Seizure Frequency in Patients with Dravet Syndrome
  (Sullivan, Dlugos, Nabbout et al)
  
  
• Quantifying “Clinically Meaningful Changes” in Seizure Frequency—Data From 3 Phase 3 Studies of ZX008 (Fenfluramine Hydrochloride Oral Solution) in Dravet Syndrome: Do Expectations and Views Change Over Time?
  (Gammaitoni, Sullivan, Dlugos et al)
  

About Dravet Syndrome

Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. Despite existing therapies, there remains a great unmet need in Dravet syndrome to reduce convulsive seizures that can lead to medical emergencies, hospitalizations, and SUDEP (sudden unexpected death in epilepsy). The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child’s well-being, can present significant emotional and logistical challenges for all members of the family.

About Zogenix

Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA^® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA, is under review in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is also developing MT1621, an investigational novel deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

Forward Looking Statements

Zogenix cautions you that statements included in this press release and the poster presentations that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include Zogenix’s development plans for FINTEPLA in Lennox-Gastaut syndrome and for MT1621, and the potential clinical value that FINTEPLA provides for Dravet syndrome patients and their families. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the timing of enrollment or results of Zogenix’s clinical trials; the COVID-19 pandemic may disrupt Zogenix’s business operations, impairing the ability to complete the planned studies of MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA or MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; additional data from Zogenix’s ongoing studies may contradict or undermine the data reported for Dravet syndrome; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACTS:

Zogenix
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732
corpcomms@zogenix.com

Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578
britchie@lifesciadvisors.com

Media
Stefanie Tuck
Vice President, Porter Novelli
+1 (978) 390-1394
stefanie.tuck@porternovelli.com

FAQ

What were the findings from Zogenix's recent presentation on FINTEPLA for Dravet syndrome?

Zogenix reported that substantial seizure reductions were sustained for up to two years in patients treated with FINTEPLA, with favorable NNT in a post-hoc analysis.

How long did the seizure reduction last for patients on FINTEPLA according to the recent data?

Patients treated with FINTEPLA maintained substantial seizure reductions for up to two years.

What is the significance of the NNT findings for FINTEPLA in Dravet syndrome?

The findings indicated that the NNT for achieving a ≥75% seizure reduction with FINTEPLA compared favorably to other Dravet syndrome therapies.

What is the regulatory status of FINTEPLA (ZGNX) in the U.S. and Europe?

FINTEPLA has been approved by the U.S. FDA and is currently under review in Europe.