SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
Date of Report (Date of earliest event reported): December
ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
or other jurisdiction
51 West 52nd Street, 7th Floor, New York, NY USA
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
communications pursuant to Rule 425 under the Securities Act (17
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d -2(b))
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e -4(c))
Securities registered pursuant to Section 12(b) of the Act:
of each class
of each exchange on which
Stock, $0.001 par value
Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17
CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2).
growth company ☐
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
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pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On December 15, 2020, Anavex Life Sciences Corp. (the “Company”)
issued a press release announcing top-line results from a U.S.
Phase 2 randomized, double-blind, placebo-controlled trial of
ANAVEX®2-73 (blarcamesine) in adult female patients with
Rett syndrome. A copy of the press release is furnished as Exhibit
99.1 to this Current Report.
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
Item 8.01 Other Events.
On December 15, 2020, the Company announced top-line results from a
U.S. Phase 2 randomized, double-blind, placebo-controlled trial of
ANAVEX®2-73 (blarcamesine) in adult female patients with
The primary endpoint of the trial was safety. The convenient oral
liquid once-daily dosing of 5 mg ANAVEX®2-73 was well-tolerated and
demonstrated dose-proportional PK (pharmacokinetics). Adverse
events related to study drug were similar between ANAVEX®2-73
(13.3%) and placebo (10%), with no reported serious adverse events
(SAEs). The safety profile of ANAVEX®2-73 in this trial is
consistent with prior clinical trial data.
All secondary efficacy endpoints of the trial showed statistically
significant and clinically meaningful sustained improvements for
ANAVEX®2-73 compared to placebo, consisting of the Rett Syndrome
Behaviour Questionnaire (RSBQ) (p = 0.048) and the Clinical Global
Impression Improvement Scale (CGI-I) score (p = 0.014) in the
intent-to-treat (ITT) population (n = 25). Statistically
significant differences in patient symptoms between the active and
placebo groups occurred as early as 4 weeks following the
initiation of ANAVEX®2-73 administration. Improvements in RSBQ
scores were correlated with parallel decreases (improvements) in
glutamate plasma levels. ANAVEX®2-73 activates the sigma-1 receptor
(SIGMAR1). Data suggests that activation of the sigma-1 receptor
(SIGMAR1) is pivotal to restoring neural cell homeostasis and
promoting neuroplasticity. Consistent with previous ANAVEX®2-73
clinical trials, patients carrying the common form of the SIGMAR1
gene treated with ANAVEX®2-73 experienced stronger improvements in
the prespecified efficacy endpoints.
All twenty-five patients in this randomized study elected to enter
a 12-week ANAVEX®2-73 extension study. The Company will be
advancing its Expanded Access Policy in order to provide long-term
therapy to current participants with Rett syndrome under an
expanded access program for ANAVEX®2-73.
Based on the results in this first of its kind U.S. Phase 2 study
in adult patients with Rett syndrome, the Company is planning to
meet with FDA to discuss the approval pathway. There are no
FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track
designation, Rare Pediatric Disease designation and Orphan Drug
designation from the FDA for the treatment of Rett syndrome and may
be considered for accelerated approval.
ANAVEX®2-73 is currently being evaluated for Rett syndrome in two
other ongoing placebo-controlled clinical studies: The Phase 2
AVATAR trial in adult Rett syndrome study and the EXCELLENCE Phase
2/3 pediatric Rett syndrome study.
The study evaluated the safety, pharmacokinetics and efficacy of
ANAVEX®2-73 in 25 adult female patients diagnosed with Rett
syndrome (positive MECP2 gene mutation).
ANAVEX®2-73 treatment yielded a statistically significant, drug
exposure-dependent response in the RSBQ Total scores, when compared
to placebo, in the ITT cohort (all participants, p = 0.048). 66.7%
of ANAVEX®2-73 treated subjects showed a statistically significant
improvement in drug exposure-dependent RSBQ response as compared to
10% of the subjects on placebo in the ITT cohort (all participants,
p = 0.011). Improvements in this adult population with Rett
syndrome, assessed by RSBQ Total scores, are considered clinically
meaningful according to published criteria applied to
neurodevelopmental disorders. ANAVEX®2-73 treatment resulted in a
sustained improvement in CGI-I scores throughout the 7-week study,
when compared to placebo in the ITT cohort (all participants, p =
0.014). 86.7% of ANAVEX®2-73 treated subjects showed a
statistically significant CGI-I response, defined as sustained
improvement to treatment, as compared to 40% of the subjects on
placebo in the ITT cohort (all participants, p = 0.014).
ANAVEX®2-73 was found to be well tolerated with very good
medication compliance during the trial. All 25 subjects completed
the study. The overall incidence of patients who experienced
adverse events related to study drug, which were mild, or moderate
was 13.3% (2) for the ANAVEX®2-73 treatment group and 10% (1) for
the placebo group. No serious treatment emergent adverse events
were reported during the course of the trial. There were no
clinically significant differences in vital signs, lab values and
EKG parameters between the active drug and placebo groups.
Collectively, the study results are consistent with the known
safety profile of ANAVEX®2-73. There was no signal for increased
risk for common disorder-related manifestations.
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
SEC. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement and Anavex Life Sciences Corp. undertakes
no obligation to revise or update this press release to reflect
events or circumstances after the date hereof.
Item 9.01 Financial Statements and Exhibits.
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.
LIFE SCIENCES CORP.
Christopher Missling, PhD
Chief Executive Officer
December 15, 2020