Neos Therapeutics Initiates and Completes Dosing in a Phase 1 Trial of NT0502 for the Treatment of Chronic Sialorrhea
January 13 2020 - 8:00AM
Neos Therapeutics, Inc. (NASDAQ: NEOS), a commercial-stage
pharmaceutical company developing and manufacturing central nervous
system-focused products, today announced that it has initiated and
completed dosing in a Phase 1 pilot pharmacokinetic study
evaluating the safety and tolerability of NT0502 in healthy
volunteers. NT0502 is a new chemical entity and selective
anticholinergic agent that, based on preclinical data, is
preferential for blocking muscarinic receptors in the salivary
glands. The Company is developing NT0502 for the treatment of
chronic sialorrhea, which is defined as prevalent and excessive
drooling from the mouth resulting from the inability to control and
swallow oral secretions, a common problem in patients with a
variety of debilitating neurological conditions. Top-line
pharmacokinetic data from the study is expected in the first
quarter of 2020.
“There is significant market need for new treatments for chronic
sialorrhea that can improve the quality of life for the millions of
patients with neurological conditions, such as Parkinson’s disease,
cerebral palsy and amyotrophic lateral sclerosis (ALS), who must
also live with the associated burden of excessive drooling,” said
Jerry McLaughlin, President and Chief Executive Officer.
“NT0502 has a novel mechanism that offers the promise of an
effective treatment with an improved tolerability profile for
patients relative to existing pharmacologic options for chronic
sialorrhea. We are looking forward to the results of this pilot
pharmacokinetic study and the continued progress of NT0502 through
the clinic.”
The Phase 1 trial for NT0502 is a single-dose open-label,
randomized study to assess the systematic exposure and safety of
four ion-resin, modified-release orally disintegrating tablet
formulations of NT0502 and oxybutynin in 30 healthy adults. Data
from this study will provide insights into the pharmacokinetic
profile of the four formulations and provide guidance on final
formulation selection and dosing for future clinical trials.
About NT0502NT0502 (N-desethyloxybutynin) is a
new chemical entity being developed as an oral, once- or
twice-daily treatment to reduce chronic sialorrhea in patients with
neurological and other conditions associated with drooling and
excessive salivation. Based on preclinical data, the Company
believes that NT0502 offers the potential for an improved
tolerability profile and an easier-to-dose oral formulation,
without the need for complex titration, compared to existing
treatment options. NT0502 is an active metabolite of oxybutynin, an
approved drug to treat a urological condition.
About SialorrheaSialorrhea is defined as
prevalent and excessive drooling from the mouth as a result of
limitations in a person’s ability to control and swallow oral
secretions. Sialorrhea can lead to significant physical and
psychosocial complications, including perioral chapping,
aspiration, dehydration, infection, foul odor, stigmatization, and
increased dependency and level of care, all of which can create an
additional burden for these medically complicated patients. In the
U.S., more than 1.4 million patients – including those suffering
from Parkinson’s disease, cerebral palsy, stroke, traumatic brain
injury, ALS and other neurological conditions – experience
sialorrhea due to neuromuscular/sensory dysfunction.1 Many of these
patients remain untreated today because existing non-selective
anticholinergic agents are associated with treatment-limiting side
effects and cumbersome dosing schedules.
About Neos Therapeutics Neos Therapeutics,
Inc. (NASDAQ: NEOS) is a fully-integrated pharmaceutical
company focused on developing, manufacturing, and commercializing
innovative medicines utilizing its proprietary modified-release
microparticle, drug delivery technology. Adzenys
XR-ODT® (amphetamine) extended-release orally disintegrating
tablets (see Full Prescribing Information, including Boxed
WARNING), Cotempla XR-ODT® (methylphenidate) extended-release
orally disintegrating tablets (see Full Prescribing
Information, including Boxed WARNING), and Adzenys-ER®
(amphetamine) extended-release oral suspension (see Full
Prescribing Information, including Boxed WARNING), all for the
treatment of ADHD, are the first three branded, approved products
using the Company’s modified-release microparticle, drug delivery
technology. In addition, Neos manufactures and markets its generic
version of the branded product Tussionex®2, an extended-release
oral suspension of hydrocodone and chlorpheniramine for the relief
of cough and upper respiratory symptoms of a cold (see Full
Prescribing Information, including Boxed WARNING). Additional
information about Neos is available
at www.neostx.com.
Forward-Looking StatementsAny statements in
this press release about future expectations, plans and prospects
for the Company, including statements about the Company’s strategy,
future operations, commercial products, clinical development of its
therapeutic candidates (including NT0502), plans for potential
future product candidates, financial condition and outlook, and
other statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “suggest,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the net sales,
profitability, and growth of the Company’s commercial products; the
status, timing, costs, results and interpretation of the Company’s
clinical trials or any future trials, including the Phase 1 study
of NT0502, whether NT0502 preferentially blocks muscarinic
receptors in the salivary glands, and whether NT0502 will be an
effective treatment with an improved tolerability profile and a
more acceptable dosing regimen for patients compared to existing
treatment options; the uncertainties inherent in conducting
clinical trials, including the timing and results of the Phase 1
study of NT0502; expectations for regulatory interactions,
submissions and approvals; the financial condition and outlook for
the Company; availability of funding sufficient for the Company’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; uncertainties related to the Company’s
intellectual property; other matters that could affect the
availability or commercial potential of the Company’s commercial
products or therapeutic candidates; and other factors discussed in
the Risk Factors set forth in the Company’s Annual Report on Form
10-K and Quarterly Reports on Form 10-Q filed with the Securities
and Exchange Commission (SEC) and in other filings the Company
makes with the SEC from time to time. In addition, the
forward-looking statements included in this press release represent
the Company’s views only as of the date hereof. The Company
anticipates that subsequent events and developments may cause the
Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so, except
as may be required by law.
References
- Mozaffarian. AHA Circulation. 2016; Taylor. MMWR Surveill Summ.
2017; Laskowitz. CRC Press; 2016; Alhashemi. Neurosciences
(Riyadh). 2010; Cohen. Int J Stroke. 2016; Maenner. Ann Epidemiol
2016; Marras. NPJ Parkinsons Dis. 2018; Kalf. J Neurol. 2009; Reid.
Dev Med Child Neurol. 2012; McGrath Epidemiol Rev. 2008; 2015
Clozapine for Treating Schizophrenia – A comparison of the States;
Maher. Ther Adv Psychopharmacol. 2016.
- Tussionex® is a registered trademark of the UCB Group of
Companies.
Contacts:
MediaJennifer GuinanSage Strategic
Marketing610.410.8111jennifer@sagestrat.com
InvestorsRichard Eisenstadt Chief Financial
OfficerNeos Therapeutics972.408.1389reisenstadt@neostx.com
Sarah McCabe Stern Investor Relations, Inc. 212.362.1200
sarah.mccabe@sternir.com
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