Section 7.01 Disclosure of FD Rules.
The information contained in this Section 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the requirements of that Section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly provided by specific reference in such filing.
Section 8.01 Other Events.
The full dataset, which builds on previously reported frontline data on
The Phase 1 clinical trial of high-dose SDX was a dose-escalation study to determine the pharmacokinetics, pharmacodynamic stimulant effects, and safety of single oral doses of SDX in subjects with a history of high-dose stimulant use. high dose. After screening, subjects were treated with single escalating doses of SDX (240, 360, 480, and 600 mg), each dose being separated by at least 14 days. A total of 14 subjects received at least one dose of SDX with 14, 10, 7, and 2 subjects dosed at 240, 360, 480, and 600 mg, respectively.
Subject-rated pharmacodynamic effects of somnolence/alertness and energy were scored on a visual analogue scale (VAS) at several time points post-dose. The results indicate that VAS scores for sleepiness/alertness (bipolar scale: 0 to 100) increased with dose with maximum effects from early to late afternoon, with the most pronounced effects measured at two highest doses. Similarly, mean VAS scores for feeling energized (unipolar scale: 0-100) increased from mean baseline scores of less than 20 and up to a maximum range of 61-82, at all dose levels. , with the largest effects measured at the two highest levels. doses. Alertness and feeling of energy are relevant pharmacodynamic measures for the treatment of patients with sleep disorders such as IH.
The Company also provided an update on several upcoming milestones for the KP1077 development program. The Company expects to file an Investigational New Drug Application for KP1077 as early as the second quarter of 2022 and then initiate a Phase 2 trial in patients with HI in the second half of 2022. Additionally, we expect to receive the results of an additional trial to assess the relative cardiovascular safety of SDX versus current stimulant treatments also in the second half of 2022.
This Form 8-K contains forward-looking statements made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as than amended. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may”, “will”, “expect”, “project”, “estimates,” “anticipates,” “plans,” “believes,” “potential,” “should,” “continue” or negative versions of these or other comparable words. Forward-looking statements are not guarantees of actions or future performance.These forward-looking statements, including the continued commercialization of AZSTARYS and the continued development of the Company’s portfolio of product candidates, or the suitability of SDX for any specific disease indication, are based information currently available to the Company and its current plans or expectations, and are subject to a number of uncertainties and risks that could materially affect the Company’s current plans. nt the activities of the Company are described in detail in the quarterly report of the Company on Form 10-Q for the quarter ended
Item 9.01 Financial statements and supporting documents.
The following documents relating to Articles 7.01 and 8.01 are deemed to have been provided and not filed:
(d) Exhibits Exhibit No. Description 99.1 Press release dated
March 21, 2022. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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