Adamas Announces Topline Phase 1b Data of ADS-4101 (lacosamide) for the Treatment of Partial Onset Seizures in Epilepsy
September 07 2017 - 8:30AM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced positive
topline data from the Phase 1b clinical trial of ADS-4101
(lacosamide) modified-release capsules. The study demonstrated that
a 600 mg dose of ADS-4101, taken once-nightly, provided a 1.7-fold
increase in average lacosamide concentrations throughout the day
compared to the maximum approved daily dose of 400 mg, taken as 200
mg twice-daily (BID), of VIMPAT® (lacosamide) immediate-release
tablets in healthy volunteers, with comparable tolerability.
ADS-4101 is an investigational drug in development for the
treatment of partial onset seizures in patents with epilepsy.
“There is an important need for new, clinically
meaningful treatment options for patients with epilepsy as even
despite advances, patients continue to suffer from seizures,” said
Rajiv Patni, MD, Chief Medical Officer of Adamas Pharmaceuticals,
Inc. “The healthy volunteer steady-state data suggest that
lacosamide concentrations achieved with the 600 mg once-nightly
dose of ADS-4101 are well above both the minimum concentration and
maximum concentration achieved with the highest approved dose of
VIMPAT, taken as 200 mg twice-daily.”
“ADS-4101 is the fourth product developed from
our validated time-dependent biology approach. The Phase 1 results
confirm ADS-4101’s innovative steady state pharmacokinetic profile,
which provides high drug concentrations during the day to match the
diurnal pattern of seizures, with lower levels at night when
seizures are less frequent,” stated Gregory T. Went, Ph.D.,
Chairman and Chief Executive Officer of Adamas Pharmaceuticals,
Inc. “We look forward to sharing these results with the epilepsy
community and discussing the next steps for the ADS-4101 program
with the FDA at an End-of-Phase 2 meeting.”
ADS-4101 Phase 1b Clinical Trial
DataThe ADS-4101 Phase 1b study was designed to evaluate
the tolerability and steady state pharmacokinetic (PK) profile of
three ascending doses of ADS-4101 compared to ascending doses of
VIMPAT in 24 healthy volunteers. The objectives of the study were
to determine the steady-state PK parameters of three dose levels of
ADS-4101 and three dose levels of VIMPAT as well as to compare
overall safety and tolerability of ADS-4101 versus VIMPAT. ADS-4101
was dosed once-nightly starting at 200 mg for Week 1, increasing to
400 mg for Week 2 and 600 mg in Week 3, compared to VIMPAT dosed
per its label at doses of 200 mg in Week 1, 300 mg in Week 2 and
400 mg in Week 3, all taken twice-daily in equal divided doses.
ADS-4101 exhibited a plasma concentration-time profile
characterized by a slow initial rise in plasma concentrations
overnight that peaked the following morning and were sustained
throughout the day. At the 600 mg dose, ADS-4101 provides a
1.7-fold increase in average lacosamide concentration throughout
the day compared to 400 mg daily, taken as 200 mg BID, of
VIMPAT.
ADS-4101 was safe and well-tolerated across all
three doses, with the highest dose of ADS-4101 (600 mg)
demonstrating equivalent tolerability when compared to a lower dose
of VIMPAT (400 mg, taken as 200 mg BID). The types of central
nervous system/psychiatric adverse events (AEs) reported during the
ADS-4101 treatment were consistent with the known VIMPAT safety
profile in healthy volunteers. For known VIMPAT AEs (oral
hypoesthesia, dizziness, abnormal dreams, and euphoria), incidences
were comparable or lower for 600 mg ADS-4101 versus 400 mg VIMPAT,
and the number of subjects with these AEs were small (<10%).
About ADS-4101ADS-4101 is an
investigational drug in development for the treatment of partial
onset seizures in patients with epilepsy. Derived from Adamas’s
validated time-dependent biology approach to drug development,
ADS-4101 is a potential high-dose, once-nightly lacosamide therapy,
with a drug profile that provides high concentrations of lacosamide
during the day to match the time when seizures occur most often.
Lacosamide is an anti-epilepsy active ingredient previously
approved by the U.S. Food and Drug Administration (FDA) and
currently marketed as VIMPAT (lacosamide).
About Adamas Pharmaceuticals,
Inc.At Adamas, we believe in the power and the promise of
medicines derived from a deep understanding of time-dependent
biology. Our expertise lies in uncovering and mapping the
relationship between disease and drug activity. From there, we
strive to create medicines with therapeutic profiles that match the
pattern of disease to drive a more significant and durable clinical
effect. This understanding of time-dependent biological processes
informs our every innovation, targeting advancement in treatment of
chronic neurologic disorders. Our portfolio includes: GOCOVRI TM
(amantadine) extended release capsules (previously ADS-5102), the
first and only FDA-approved medicine for the treatment of
dyskinesia in patients with Parkinson’s disease receiving
levodopa-based therapy, with or without concomitant dopaminergic
medications; ADS-5102 in development for the treatment of multiple
sclerosis walking impairment, and ADS-4101, a high-dose,
modified-release lacosamide in Phase 1 clinical development for the
treatment of partial onset seizures in patients with epilepsy.
Additionally, Adamas’s licensed assets are currently marketed by
Allergan under the brand names NAMENDA XR® and NAMZARIC®, and
Adamas is eligible to receive royalties on sales of these medicines
beginning in June 2018 and May 2020, respectively. For more
information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz
Pharma GmbH & Co. KGaA. VIMPAT® is a trademark of UCB.
Contact:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3567
Email: ir@adamaspharma.com
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