Jupiter Neurosciences Announces JOTROL Manufacturing Agreement with Catalent to Support Phase 2a Parkinson’s Trial
04 February 2025 - 12:00AM
Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the
“Company”), a clinical-stage pharmaceutical company developing
JOTROL™, a patented resveratrol-based platform, today announced it
has entered into an agreement with Catalent Pharma Solutions, LLC
("Catalent") for the production of JOTROL™ softgel capsules to
support Jupiter’s upcoming Phase 2a clinical trial in Parkinson’s
disease.
Under the terms of the agreement, Catalent will
manufacture clinical batches of JOTROL, Jupiter’s proprietary
resveratrol-based therapeutic, using an optimized softgel
formulation. The production will include both active and placebo
batches for the Parkinson’s study. This manufacturing initiative
will be conducted under current Good Manufacturing Practices (CGMP)
to meet regulatory and clinical standards.
“Securing an experienced CDMO leader like
Catalent is a critical step as we advance JOTROL into clinical
development for Parkinson’s disease,” said Christer Rosén, Chairman
and CEO of Jupiter Neurosciences. “Catalent’s industry-leading
expertise in pharmaceutical manufacturing and its ability to scale
production efficiently according to a tight timeline will help us
maintain momentum in our development program and support our goal
of delivering innovative therapies to patients.”
JOTROL is designed to overcome the historical
challenges of resveratrol by significantly enhancing
bioavailability while minimizing gastrointestinal side effects. The
upcoming Phase 2a trial will evaluate the safety, tolerability, and
pharmacokinetics/pharmacodynamics (PK/PD) of JOTROL in Parkinson’s
patients over a three-month period.
With over 10 million people affected by
Parkinson’s disease worldwide, there remains an urgent need for
innovative treatments. The Parkinson’s therapeutics market is
projected to exceed $14 billion by 2030. Jupiter Neurosciences
continues to pursue strategic partnerships to accelerate JOTROL’s
development across multiple indications, including Alzheimer’s and
other neurodegenerative diseases.
About Jupiter Neurosciences, Inc.
Jupiter Neurosciences is a clinical-stage
pharmaceutical company focused on treating neuroinflammation, with
a current focus on CNS disorders and rare diseases. The Company’s
platform product, JOTROL™, is an enhanced orally administered
resveratrol formulation designed and intended to deliver
therapeutically relevant, safe levels of resveratrol. The Company’s
pipeline is focused broadly on CNS disorder and includes
indications such as Alzheimer’s Disease, Parkinson’s Disease,
Mucopolysaccharidoses Type I, Friedreich’s Ataxia, and MELAS. More
information may be found on the Company’s
website www.jupiterneurosciences.com.
About JOTROL
Resveratrol is one of the world’s most
extensively researched molecules. Thorough evaluation has shown
that for the compound to be effective, it requires a high C-Max
(~300 ng/ml of resveratrol in plasma), achievable only with doses
exceeding 3 grams using earlier resveratrol products. Poor
bioavailability has been a well-documented issue with resveratrol.
Doses over 2 grams have been associated with severe
gastrointestinal (GI) side effects, which have prevented the
compound from receiving regulatory approval for any indication.
Jupiter Neurosciences (JUNS) conducted a Phase I
study demonstrating that JOTROL achieves over nine times higher
bioavailability compared to resveratrol used in earlier clinical
trials (e.g., Turner et al., MCI/Early Alzheimer’s Disease trial,
and Yui et al., Friedreich’s Ataxia trial). The results of this
Phase I study, which will be cross-referenced in all upcoming
JOTROL trials, were published in the Journal of Alzheimer’s Disease
and AAPS Open in February 2022.
About Catalent
Catalent, Inc. is a leading global contract
development and manufacturing organization (CDMO) whose mission is
to develop, manufacture, and supply products that help people live
better and healthier lives. Catalent is dedicated to delivering
unparalleled service to pharma, biotech, and consumer health
customers, supporting product development, launch, and full
life-cycle supply. With time-tested experience in development
sciences, delivery technologies, and multi-modality manufacturing,
Catalent supports the acceleration of development programs and the
launch of more than a hundred new products every year. Powered by
thousands of scientists and technicians and the latest technology
platforms at more than 40 global sites, Catalent supplies billions
of doses of life-enhancing and life-saving treatments for patients
annually. For more information, visit www.catalent.com.
FORWARD-LOOKING STATEMENTS
Certain statements in this announcement are
forward-looking statements. These forward-looking statements
involve known and unknown risks and uncertainties and are based on
the Company’s current expectations, including the use of proceeds
from the Offering. Investors can find many (but not all) of these
statements by the use of words such as “approximates,” “believes,”
“hopes,” “expects,” “anticipates,” “estimates,” “projects,”
“intends,” “plans,” “will,” “would,” “should,” “could,” “may” or
other similar expressions. Although the Company believes that the
expectations expressed in these forward-looking statements are
reasonable, it cannot assure you that such expectations will turn
out to be correct. The Company cautions investors that actual
results may differ materially from the anticipated results and
encourages investors to read the risk factors contained in the
Company’s final prospectus and other reports it files with the SEC
before making any investment decisions regarding the Company’s
securities. The Company undertakes no obligation to update or
revise publicly any forward-looking statements to reflect
subsequent occurring events or circumstances, or changes in its
expectations, except as may be required by law.
Contact:
Dave GentryRedChip Companies, Inc.1-407-644-42561-800-RED-CHIP
(733-2447)JUNS@redchip.com
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