Item 7.01 Regulation FD Disclosure.
On
The information furnished pursuant to Item 7.01 of this Current Report, including Exhibit 99.1 hereto, shall not be considered "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of such section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended, or under the Exchange Act, unless the Company expressly sets forth in such future filing that such information is to be considered "filed" or incorporated by reference therein.
Item 8.01 Other Events.
On
The study found that ANAVEX®2-73 (blarcamesine) was safe and well tolerated in
oral doses up to 50 mg once daily. The results show clinically meaningful,
dose-dependent, and statistically significant improvements in the
The ANAVEX®2-73-PDD-001 study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study and randomized 132 patients with PDD equally to target doses of 30mg, 50mg ANAVEX®2-73 (blarcamesine) or placebo, respectively. In addition to safety and cognitive efficacy, sleep function was assessed during the study at week 8 and week 14.
ANAVEX®2-73-PDD-001 study results will be submitted for presentation at a medical conference and for publication in a peer-reviewed medical journal. Anavex is planning a pivotal trial of ANAVEX®2-73 (blarcamesine) in Parkinson's disease dementia after submitting the results of the study to the FDA to obtain regulatory guidance.
After completing the trial, participants were able to enroll in a voluntary 48-week open-label extension study, ANAVEX®2-73-PDD-EP-001, which continues to assess safety, long term efficacy and changes in gut microbiota.
ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor, which has been shown to be pivotal to restoring neural cell homeostasis and promoting neuroplasticity.
Forward-Looking Statements
Statements in this Current Report on Form 8-K that are not strictly historical
in nature are forward-looking statements. These statements include, but are not
limited to, statements relating to the implications of clinical data, any
subsequent presentation related thereto and any future studies. These statements
are only predictions based on current information and expectations and involve a
number of risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to various
factors, including the risks set forth in the Company's most recent Annual
Report on Form 10-K filed with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits 99.1 Press Release of the Company datedOctober 15, 2020 1
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