Zynerba Pharmaceuticals Announces Twelve Month ZYN002 Data from STAR 2 Study in Patients with Focal Seizures at the 2018 Annu...
April 25 2018 - 7:00AM
Continued Improvement in Seizure Control Seen in
Adult Refractory Focal Seizure Patients Receiving ZYN002 through 12
Months of Open Label Exposure
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage
specialty neuropsychiatric pharmaceutical company dedicated to
developing and commercializing innovative pharmaceutically-produced
transdermal cannabinoid treatments for rare and near-rare
neurological and psychiatric disorders with high unmet medical
needs, is reporting new longer term open label clinical data today
in the Emerging Science session of the 2018 Annual Meeting of the
American Academy of Neurology (AAN) in Los Angeles, CA.
In a poster presentation entitled, “Transdermal
Cannabidiol (CBD) Gel for the Treatment of Focal Epilepsy in
Adults” (poster P4.468), Dr. John Messenheimer presents additional
data from ongoing STAR 2
(Synthetic Transdermal
CAnnabidiol for the TReatment of
Epilepsy) 24-month open label extension study evaluating ZYN002
cannabidiol (CBD) transdermal gel in adult patients with focal
seizures. The presentation includes data through twelve months of
open label exposure to ZYN002.
The key findings include that responses to ZYN002
in the STAR 2 open label extension, as measured by reductions in
focal seizures from the baseline period of STAR 1, are associated
with continued treatment with ZYN002. In addition, ZYN002 was shown
to be well tolerated through 12 months of treatment in STAR 2.
“These data continue to suggest that focal seizures
may be reduced with longer-term exposure to transdermally-delivered
CBD,” said Dr. Liza Squires, Zynerba’s Chief Medical Officer. “In
this population of patients, the use of ZYN002 for an additional 12
months in STAR 2 was well tolerated and appeared to result in
clinically meaningful seizure reductions both across and within the
originally randomized STAR 1 groups. These data continue to provide
insight into the potential for ZYN002 in certain epilepsies, and we
look forward to initiating a Phase 2b study in adult refractory
focal seizures in the second half of 2018.”
The data presented in the poster are as
follows:
- 188 patients were randomized, 186 were analyzed for efficacy,
and 174 completed STAR 1;
- 171 patients (98% of STAR 1 completers) continued into STAR
2;
- As of December 12, 2017, 95 patients remained in the STAR 2
study;
- Patients were taking a wide range of antiepileptic drugs
(AEDs), the most common of which are levetiracetam, carbamazepine,
lamotrigine, lacosamide, and valproate.
Efficacy
- In STAR 2, longer term exposure to
ZYN002 resulted in greater improvements in seizure frequency among
all ZYN002-treated patients;
- Longer term exposure to ZYN002
appeared to result in clinically meaningful reductions in seizures
both across and within originally randomized STAR 1 patient
groups:- Compared to baseline, the median changes in seizure rates
at months 3, 6, 9, and 12 of STAR 2 across all ZYN002-treated
patients at each time point were:— 25% reduction at month 3
(N=171)— 36% reduction at month 6 (N=146)— 49% reduction
at month 9 (N=112)— 58% reduction at month 12 (N=70)- A photo
accompanying this announcement is available
at: http://resource.globenewswire.com/Resource/Download/1d9eb21b-8ff9-40e4-be0f-db0561d94621-
Compared to baseline, the median changes in seizure rates at months
3, 6, 9, and 12 of STAR 2 in patients initially treated with
placebo or ZYN002 in STAR 1 were:
|
|
|
Median Change (%) in Seizure Rates in STAR 2 Study |
|
|
Month 3 |
|
Month 6 |
|
Month 9 |
|
Month 12 |
|
Placebo (STAR 1) |
|
-10 (n=60) |
|
-16 (n=49) |
|
-41 (n=37) |
|
-57 (n=24) |
|
ZYN002 195 mg (STAR 1) |
|
-32 (n=56) |
|
-48 (n=49) |
|
-55 (n=39) |
|
-63 (n=25) |
|
ZYN002 390 mg (STAR 1) |
|
-31 (n=55) |
|
-38 (n=48) |
|
-46 (n=36) |
|
-59 (n=21) |
- A photo accompanying this announcement is available
at: http://resource.globenewswire.com/Resource/Download/e17084af-5352-4851-8843-556420cf1e73
Safety
- ZYN002 was well tolerated with good skin tolerability;
- In STAR 2, the most common treatment-emergent AEs (> 7.5%)
were upper respiratory tract infection (viral and bacterial [17%])
and headache (11%);
- One serious AE was considered possibly related to ZYN002
(increased anxiety);
- There were no clinically significant abnormal liver AEs (i.e.
alanine aminotransferase/aspartate aminotransferase) >3x upper
limit of normal reported for patients receiving ZYN002.
A copy of the poster presentation is currently
available on the Zynerba corporate website
at: http://zynerba.com/publications/
About ZYN002
Zynerba’s ZYN002 CBD gel is the first and only
pharmaceutically-produced CBD formulated as a patent-protected
permeation-enhanced gel and is being studied in children with
Fragile X Syndrome, adult epilepsy patients with focal seizures and
osteoarthritis. ZYN002 is a clear, permeation-enhanced gel that is
designed to provide controlled drug delivery transdermally with
once- or twice-daily dosing.
About Zynerba Pharmaceuticals,
Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a
clinical-stage specialty pharmaceutical company dedicated to
developing and commercializing innovative pharmaceutically-produced
transdermal cannabinoid treatments for rare or near-rare
neuropsychiatric diseases with high unmet medical needs. We are
dedicated to improving the lives of people with severe health
conditions by developing cannabinoid medicines designed to meet the
rigorous efficacy and safety standards established by global
regulatory agencies. Through the discovery and development of these
potentially life-changing medicines, Zynerba seeks to improve the
lives of patients battling severe, chronic health conditions
including Fragile X syndrome, refractory epilepsies, Tourette
Syndrome, and other neuropsychiatric disorders. Learn more at
www.zynerba.com and follow the Company on Twitter at
@ZynerbaPharma.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. We may, in some cases, use terms such as
“predicts,” “believes,” “potential,” “proposed,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from the Company’s current
expectations. For example, there can be no guarantee that the
Company will obtain approval for ZYN002 or ZYN001 from the U.S.
Food and Drug Administration (FDA) or foreign regulatory
authorities; even if ZYN002 or ZYN001 are approved, the Company may
not be able to obtain the label claims that it is seeking from the
FDA. In addition, the Company’s cash and cash equivalents may not
be sufficient to support its operating plan for as long as
anticipated. Management’s expectations and, therefore, any
forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other
factors, including the following: the success, cost and timing of
the Company’s product development activities, studies and clinical
trials; the success of competing products that are or become
available; the Company’s ability to commercialize its product
candidates; the size and growth potential of the markets for the
Company’s product candidates, and the Company’s ability to service
those markets; the Company’s ability to develop sales and marketing
capabilities, whether alone or with potential future collaborators;
the rate and degree of market acceptance of the Company’s product
candidates; and the Company’s expectations regarding its ability to
obtain and adequately maintain sufficient intellectual property
protection for its product candidates. This list is not exhaustive
and these and other risks are described in the Company’s periodic
reports, including the annual report on Form 10-K, quarterly
reports on Form 10-Q and current reports on Form 8-K, filed with or
furnished to the Securities and Exchange Commission and available
at www.sec.gov. Any forward-looking statements that the
Company makes in this press release speak only as of the date of
this press release. The Company assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Zynerba ContactWill Roberts, VP
Investor Relations and Corporate
Communications484.581.7489robertsw@zynerba.com
Media contactTheresa Dolge Tonic
Life CommunicationsOffice:
215-928-2748Theresa.Dolge@toniclc.com
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