New FINTEPLA® (fenfluramine) data shows long-term reductions in seizure frequency in patients with Lennox-Gastaut syndrome (LGS)

  • The median reduction in the frequency of gout attacks was 39.4% at 3 months (n = 227; p

  • A Supplementary New Drug Application (sNDA) was recently submitted seeking FDA approval for the use of FINTEPLA in LGS.

EMERYVILLE, Calif., Sept. 30, 2021 (GLOBE NEWSWIRE) – Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing therapies for rare diseases, today announced data from an interim analysis of a Phase 3 in 12 month open label extension study (OLE) (Study 1601; Part 2) showing that treatment with FINTEPLA® (fenfluramine) led to a clinically significant and sustained reduction in gout attacks in patients with Lennox-Gastaut syndrome (LGS) on antiepileptic drugs (ASM). LGS is a rare and severe form of childhood epilepsy in which seizures are extremely difficult to control and are associated with significant cognitive, behavioral and motor impairments. These data were presented today at the 2021 Annual Meeting of the Child Neurology Society (CNS), which will be held from September 29 to October 2, 2021.

“We are delighted to present this study review on the effect of long-term treatment of FINTEPLA for patients with LGS in need of relief from the significant burden associated with lifelong treatment-resistant seizures,” said Kelly Knupp, MD, MSCS, FAES associate professor at Children’s Hospital Colorado and principal investigator of the study. “These results highlight the potential of FINTEPLA to reduce the frequency of seizures experienced by patients with LGS in order to significantly improve long-term disease-associated outcomes. “

Study results
A total of 247 patients (mean age, 14 years) entered the OLE study after completing the randomized, controlled portion of Study 1601. An interim analysis was performed when> 90% of patient data was available. . The median frequency of gout attacks before study treatment was 75 per month (range 4 to 2943).

The results presented at the deadline showed that patients experienced significant improvements in the frequency of seizures in the OLE study. During the treatment period, the median reduction in the frequency of gout attacks was 39.4% at 3 months (n = 227; p

“We are very pleased with the compelling results of this study analysis demonstrating the potential long-term impact and clinical benefit of FINTEPLA for LGS patients, who face challenges in finding effective seizure control,” said Gail Farfel, Ph.D., Executive Vice President. President and Director of Development at Zogenix and one of the study authors. “We are also pleased to have recently submitted an additional new drug application requesting approval for the use of FINTEPLA for the treatment of seizures associated with LGS..

In the long-term trial, FINTEPLA was generally well tolerated with no valvular disease or pulmonary hypertension observed. The most common treatment-related adverse reactions were decreased appetite (n = 40, 16.2%), fatigue (n = 33, 13.4%), nasopharyngitis (n = 31, 12, 6%) and seizures (n = 27, 10.9%). The death of a patient has occurred; the cause was reported as aspiration pneumonia and was considered unrelated to the study drug.

The poster, titled “FINTEPLA (fenfluramine) Provides Clinically Significant Reduction in Seizure Frequency Leading to Decrease in Lennox-Gastaut Syndrome Patients Up to 1 Year: Interim Analysis of an Extension Study in open ”(Kelly G. Knupp, Ingrid E. Scheffer, Berten Ceulemans, et al) is available on the Zogenix press room.

About OLE Intermediate Analysis
Patients with LGS who completed a randomized Phase 3 clinical trial and were eligible could enroll in the OLE study (NCT03355209). Efficacy and safety / tolerability were assessed at months 1, 2 and 3, then at 3 month intervals. A total of 247 patients had enrolled in the OLE as of October 19, 2020 and had received at least 1 dose of the study drug in the OLE.

About Lennox-Gastaut syndrome
Lennox-Gastaut syndrome (LLS) is a rare and devastating childhood epilepsy that can occur from several different causes. LGS is characterized by many types of seizures, many of which result in frequent falls and injuries, and which often do not respond to currently available anti-epileptic drugs The intellectual and behavioral problems associated with LGS, as well as the need for 24-hour care add to the complexity of living with this disease.

About Zogenix
Zogenix is ​​a global biopharmaceutical company engaged in the development and commercialization of therapies with the potential to transform the lives of patients and their families living with rare diseases. The Company’s First Rare Disease Treatment, FINTEPLA® (fenfluramine) oral solution, has been approved by the US FDA and the European Medicines Agency. In Japan, Zogenix is ​​in the process of submitting a New Drug Application (J-NDA) for FINTEPLA for the treatment of seizures associated with Dravet syndrome at the end of 2021. Lennox-Gastaut syndrome and one in a mitochondrial disease called deficiency in TK2. Zogenix also plans to initiate a study on FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is working with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

Forward-looking statements
Zogenix cautions you that statements included in this press release that are not descriptions of historical fact are forward-looking statements. Words such as “believes”, “anticipates”, “plans”, “expects”, “indicates”, “will”, “intention”, “potential”, “suggests”, “assuming”, “Designed” and similar expressions are intended to identify forward-looking statements. These statements include the potential of FINTEPLA to reduce the frequency of seizures and provide clinical benefit to LGS patients, if approved, as well as statements regarding the clinical development plans of Zogenix. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be taken as a representation by Zogenix that any of its plans will be realized. Actual results may differ from those presented in this press release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: interim data from the OLE study and other clinical trials may change at as more patient data becomes available and is subject to audit and verification procedures that could result in significant changes in the final data; the COVID-19 pandemic could continue to disrupt Zogenix business operations, including the schedule of clinical visits in the ongoing OLE study, which would compromise regulatory submissions and approvals; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine which could limit regulatory approval or marketing, or which could lead to recalls or product liability claims; the possibility for the FDA to delay the timing of the sNDA review due to internal FDA resource constraints or for other reasons; and other risks described in previous Zogenix press releases as well as in periodic public filings with the United States 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 makes no commitment to revise or update this press release to reflect any events or circumstances. subsequent to the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This warning is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACTS:

Zogenix
[email protected]

Investors
Brian ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | [email protected]

Media
Trish McCall, Porter Novelli
+1 (805) 390-3279 | [email protected]

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