UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On September 10, 2020, Zogenix, Inc. (the “Company”) reported positive top-line results from its third Phase 3 study (Study 3) of FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome. The study corroborates the substantial impact of FINTEPLA on convulsive seizure reduction previously demonstrated in two earlier Phase 3 trials (Studies 1 and 2) in patients with this severe, rare and often debilitating form of infant-onset epilepsy. It also expands the countries where FINTEPLA has been evaluated to include Japan and Study 3 will be the pivotal study included in the Company’s planned submission of a new drug application (“J-NDA”) in that country, expected to occur in 2021.
Study 3 was a multi-national, randomized, double-blind, placebo-controlled, Phase 3 study enrolling 143 children and young adults with Dravet syndrome, whose seizures were not adequately controlled by existing anti-epileptic drugs. The median age of patients was 9 years (range, 2-18 years) and the average baseline convulsive seizure frequency across the study groups was approximately 63 seizures per month.
Following a six-week baseline observation period, patients were randomized to one of three treatment groups: FINTEPLA 0.7 mg/kg/day (26 mg maximum daily dose; n=49), FINTEPLA 0.2 mg/kg/day (n=46) or placebo (n=48), in which FINTEPLA or placebo was added to each patient’s current treatment regimen of anti-epileptic drugs. Patients were titrated to their target dose of FINTEPLA over two weeks and then remained at that fixed dose for 12 weeks.
The study met its primary objective in demonstrating that patients in the FINTEPLA 0.7 mg/kg/day group achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group (p<0.0001). The median percent reduction in monthly convulsive seizure frequency was 73.7% among FINTEPLA 0.7 mg/kg/day patients compared to 7.6% in placebo patients.
The same analyses comparing FINTEPLA at a lower dose of 0.2 mg/kg/day versus placebo was a key secondary objective and demonstrated that patients in the lower dose group achieved a 49.9% greater reduction in mean monthly convulsive seizures compared to placebo (p<0.0001). Collectively, these top-line data are highly consistent with the results of Study 1 in demonstrating a dose-response relationship for FINTEPLA in the treatment of convulsive seizures in Dravet syndrome.
Additional key secondary objectives of the study were to compare FINTEPLA 0.7 mg/kg/day and 0.2 mg/kg/day (independently) with placebo in terms of (1) the proportion of patients who achieved ³50% reductions in monthly convulsive seizures and (2) the median of the longest convulsive seizure-free interval. These results are shown in the following table. The proportion of patients who achieved ³75% seizure reductions, a secondary efficacy measure, is also presented.
| FINTEPLA 0.7 mg/kg/day (N=48) |
FINTEPLA 0.2 mg/kg/day (N=46) |
Placebo (N=48) | ||||
| Patients with ³50% reduction in monthly convulsive seizures |
72.9% (p<0.0001) |
45.7% (p<0.0010) |
6.3% | |||
| Patients with ³75% reduction in monthly convulsive seizures |
47.9% (p=0.0001) |
28.3% (p=0.0047) |
4.2% | |||
| Longest seizure-free interval (median) |
43 days (p<0.0001) |
24 days (p<0.0010) |
13.3 days | |||
FINTEPLA was generally well-tolerated in this study, with adverse events consistent with those observed in Study 1 and Study 2 and with the known safety profile of fenfluramine. The incidence of treatment-emergent adverse events was higher in the treatment groups as compared to the placebo group, with 91.7% (n=44) of patients in the 0.7 mg/kg/day group and 91.3% (n=42) of patients in the 0.2 mg/kg/day group experiencing at least one treatment-emergent adverse event compared to 83.3% (n=40) of patients in the placebo group. The incidence of serious adverse events was similar in all three groups with 6.3% (n=3) of patients in the 0.7 mg/kg/day group and 6.5% (n=3) of patients in the 0.2 mg/kg/day group experiencing at least one treatment-emergent serious adverse event compared to 4.2% (n=2) of patients in the placebo group, including one placebo patient who died due to SUDEP (sudden unexpected death in epilepsy). Prospective cardiac safety monitoring throughout the study showed that no study patients developed valvular heart disease or pulmonary arterial hypertension.
FINTEPLA was approved by the U.S. Food and Drug Administration (“FDA”) in June 2020 for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older and a Marketing Authorization Application (“MAA”) is under review by the European Medicines Agency (“EMA”). In March 2019, the Company entered into an exclusive distribution agreement with Nippon Shinyaku, Co., Ltd. for the commercialization of FINTEPLA in Japan. The Company will supply product to Nippon Shinyaku and retains responsibility for completing its global clinical development programs for FINTEPLA, including those underway to support the Company’s planned submissions of new drug applications in Japan for Dravet syndrome and Lennox-Gastaut syndrome.
Forward-Looking Statements
The Company cautions you that statements included in this report 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: FINTEPLA providing an important treatment option for patients with Dravet syndrome; the Company’s plans to submit the J-NDA supported by the Study 3 trial results and the timing thereof; the Company’s belief that results from Study 3 corroborate the results from Study 1 and Study 2; and the Company’s plans to bring FINTEPLA to patients in additional countries over time. These statements are based on the Company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by the Company 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 the Company’s business, including, without limitation: top-line data the Company reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial, and the Japanese regulatory authority may not agree with the Company’s interpretation of such results; the Japanese regulatory authority may disagree that results of Study 3 may serve as a pivotal trial to support the J-NDA or that the existing safety and efficacy data, or the Company’s analysis of such data, is sufficient to support marketing approval in Japan; the COVID-19 pandemic may disrupt the Company’s business operations, impairing the ability to commercialize FINTEPLA and the Company’s ability to generate product revenue; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit commercialization, or that could result in recalls or product liability claims; additional data from the Company’s ongoing studies may contradict or undermine the data reported for Dravet syndrome; the Company’s dependence on third parties for the manufacture of FINTEPLA; and other risks described in the Company’s 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 the Company undertakes no obligation to revise or update this report 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZOGENIX, INC. | ||||||
| Date: September 10, 2020 | By: | /s/ Shawnte M. Mitchell | ||||
| Name: | Shawnte M. Mitchell | |||||
| Title: | Executive Vice President, General Counsel and Secretary | |||||
Document and Entity Information |
Sep. 10, 2020 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001375151 |
| Document Type | 8-K |
| Document Period End Date | Sep. 10, 2020 |
| Entity Registrant Name | ZOGENIX, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-34962 |
| Entity Tax Identification Number | 20-5300780 |
| Entity Address, Address Line One | 5959 Horton Street |
| Entity Address, Address Line Two | Suite 500 |
| Entity Address, City or Town | Emeryville |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 94608 |
| City Area Code | (510) |
| Local Phone Number | 550-8300 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, par value $0.001 per share |
| Trading Symbol | ZGNX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |