12/30/2014
9:52 AM ET
Clinical-stage
pharmaceutical company
NeuroDerm Ltd. (NDRM: Quote), which
went public in November, announced Tuesday topline results for a mid-stage
study for its proprietary liquid levodopa/carbidopa (LD/CD) product candidates
as a treatment for Parkinson's disease.
NeuroDerm Ltd. (NDRM: Quote), which
went public in November, announced Tuesday topline results for a mid-stage
study for its proprietary liquid levodopa/carbidopa (LD/CD) product candidates
as a treatment for Parkinson's disease.
Following
the announcement, the company's shares are skyrocketing more than 49 percent in
early deals.
The
company said the continuous, subcutaneous delivery of the liquid product
candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa
levels. The company added that ND0612H, the higher dose version, provided an effective
alternative to current treatments
that require surgery.
alternative to current treatments
that require surgery.
"Maintaining
consistent levodopa concentrations has been the most significant hurdle in
Parkinson's disease therapy. The results from this study demonstrate that
ND0612H can reach high LD plasma levels that, to date, could only be reached
and maintained by products that require surgical intervention," said
Sheila Oren, NeuroDerm's Vice President
of Clinical and Regulatory
Affairs.
of Clinical and Regulatory
Affairs.
The
phase IIa study was conducted on 16 patients with an advanced form of
Parkinson's disease having motor fluctuations that was chronically treated with
standard of care oral LD/CD. The primary endpoints of the study were to assess
the safety
, tolerability and pharmacokinetics
(PK) of six dose regimens of ND0612H and ND0612L.
, tolerability and pharmacokinetics
(PK) of six dose regimens of ND0612H and ND0612L.
The
patients were treated with ND0612L (n=9) or ND0612H (n=7) for eight hours per
day, for three consecutive days, with high and low doses of CD, and with
adjunct oral entacapone. The LD/CD product candidates are continuously
administered subcutaneously through a belt-worn pump.
The
trial results showed that patients receiving ND0612H achieved maximum daytime
levodopa plasma concentrations of 1,333ng/ml and 1,807ng/ml with oral entacapone
added.
Meanwhile,
patients receiving ND0612L achieved maximum daytime concentrations of 528ng/ml
and 596ng/ml with oral entacapone added.
The
company confirmed that all patients completed the study and treatment with
ND0612L and ND0612H did not raise safety and tolerability concerns.
Rehovot,
Israel-based NeuroDerm focuses on developing
drugs for central nervous system
(CNS) diseases.
drugs for central nervous system
(CNS) diseases.
The
company noted that it will now proceed with the clinical development of ND0612H
and ND0612L in the U.S. and the European Union in 2015, based on the promising
mid-stage trial results.
Parkinson's
disease is a progressive neurodegenerative illness characterized by reduced
dopamine in the brain, resulting in a debilitating decrease in the patient's motor
and non-motor functions. Its symptoms,
such as trembling in the extremities and face, slowness of movement and
impaired balance and coordination, worsen over time and gravely impact the
patient's quality of life.
and non-motor functions. Its symptoms,
such as trembling in the extremities and face, slowness of movement and
impaired balance and coordination, worsen over time and gravely impact the
patient's quality of life.
In
Tuesday's regular trading session, NDRM is currently trading at $9.23, up $3.05
or 49.35% on a volume of 2.32 million shares. In the past 52-week period, the
stock has been trading in a range of $5.67 to $9.45.
http://health.einnews.com/article/242017194/ItAVG8YB69zTAz2e
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