Praxis Precision Medicines Announces Positive Results of EEG Analysis of PRAX-628 Phase 1 Study
07 Agosto 2023 - 1:00PM
Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage
biopharmaceutical company translating genetic insights into the
development of therapies for central nervous system (CNS) disorders
characterized by neuronal excitation-inhibition imbalance, today
announced the results from an analysis of EEG activity for subjects
in the recent Phase 1 study that demonstrated pharmacodynamic
activity across all dose levels for study subjects who received
PRAX-628 at first administration as compared with subjects who
received placebo.
PRAX-628 is a next generation functionally selective small
molecule targeting the hyperexcitable state of sodium channels in
the brain, which is currently being developed as a rapid acting,
once daily, oral treatment for adult focal onset epilepsy.
“We are very pleased to see that PRAX-628 reached the brain at
therapeutic levels. Combined with the PRAX-628 data we have already
seen, including its solid safety results, rapid onset and wide
therapeutic window, we maintain our expectations that PRAX-628 has
the potential to be the best-in-class treatment for patients
suffering from focal epilepsy. We look forward to sharing the
results of our ongoing Phase 2 PPR study later this year, and soon
after initiating a Phase 2 study in focal epilepsy,” said
Marcio Souza, president and chief executive officer of Praxis.
Summary of PRAX-628 Phase 1 qEEG Analysis:
- In the Phase 1 study, PRAX-628 was administered to 40 healthy
participants (PRAX-628 n=30, placebo n=10). Single ascending dose
(SAD) cohorts evaluated PRAX-628 doses ranging from 5 to 45 mg and
multiple ascending dose (MAD) cohorts evaluated PRAX-628 doses of
20 and 30 mg.
- EEG data were collected over the course of Day 1 in the SAD
cohort and over three separate days during the course of the 10-day
MAD treatment period.
- qEEG analysis showed a pharmacodynamic effect at all dose
levels and was significantly different from placebo at the Tmax
timepoint (~2h) for the SAD and all timepoints for the MAD
portion.
Additional results from the PRAX-628 Phase 1 study will be
presented at an upcoming medical conference. Praxis has begun a
Phase 2 study for PRAX-628 in patients with a PPR to evaluate drug
activity and dose finding, which is expected to report topline
results in the second half of 2023. Based on these studies and the
preclinical results, Praxis intends to advance PRAX-628 into a
Phase 2 study in focal epilepsy in the first half of 2024.
About PRAX-628PRAX-628 is a next-generation,
functionally selective small molecule targeting the hyperexcitable
state of sodium-channels in the brain that is currently being
developed as a once daily, oral treatment for adult focal onset
epilepsy. Preclinical data demonstrates PRAX-628 is differentiated
from standard of care, with the potential to be best-in-class for
focal epilepsy. In vitro, PRAX-628 has demonstrated superior
selectivity for disease-state NaV channel hyperexcitability. In
vivo studies of PRAX-628 have demonstrated unprecedented potency in
the maximal electroshock seizure (MES) model, a highly
predictive translational model for efficacy in focal epilepsy. Data
from the PRAX-628-101 study demonstrated that PRAX-628 can be
safely dosed in healthy subjects to greater than 15 times the
predicted human equivalent of the rodent MES EC50, a translational
guide that suggest the therapeutic window results in unprecedented
magnitude relative to approved therapies.
About PraxisPraxis Precision Medicines is a
clinical-stage biopharmaceutical company translating insights from
genetic epilepsies into the development of therapies for CNS
disorders characterized by neuronal excitation-inhibition
imbalance. Praxis is applying genetic insights to the discovery and
development of therapies for rare and more prevalent neurological
disorders through our proprietary small molecule platform,
Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™,
using our understanding of shared biological targets and circuits
in the brain. Praxis has established a diversified, multimodal CNS
portfolio including multiple programs across movement disorders and
epilepsy, with four clinical-stage product candidates. For more
information, please visit www.praxismedicines.com and follow
us on Facebook, LinkedIn and Twitter.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995 and other federal
securities laws, including express or implied statements regarding
Praxis’ future expectations, plans and prospects, including,
without limitation, statements regarding the clinical development
of PRAX-628, as well as other statements containing the words
“anticipate,” “believe,” “continue,” “could,” “endeavor,”
“estimate,” “expect,” “anticipate,” “intend,” “may,” “might,”
“plan,” “potential,” “predict,” “project,” “seek,” “should,”
“target,” “will” or “would” and similar expressions that constitute
forward-looking statements under the Private Securities Litigation
Reform Act of 1995.
The express or implied forward-looking statements included in
this press release are only predictions and are subject to a number
of risks, uncertainties and assumptions, including, without
limitation: uncertainties inherent in clinical trials; the expected
timing of clinical trials, data readouts and the results thereof,
and submissions for regulatory approval or review by governmental
authorities; regulatory approvals to conduct trials; and other
risks concerning Praxis’ programs and operations as described in
its Annual Report on Form 10-K for the year ended December 31,
2022, its Quarterly Reports on Form 10-Q and other filings made
with the Securities and Exchange Commission. Although Praxis’
forward-looking statements reflect the good faith judgment of its
management, these statements are based only on information and
factors currently known by Praxis. As a result, you are cautioned
not to rely on these forward-looking statements. Any
forward-looking statement made in this press release speaks only as
of the date on which it is made. Praxis undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future developments or otherwise.
Investor Contact
Praxis Precision Medicines
investors@praxismedicines.com
857-702-9452
Media Contact
Ian Stone
Canale Communications
Ian.stone@canalecomm.com
619-849-5388
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