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JUPITER,
Fla., Jan. 11, 2021 /PRNewswire/
-- Jupiter Orphan Therapeutics, Inc. ("JOT") a biotechnology
company pioneering a novel and disease modifying product named JOTROL™,
today announced that the first patient has been dosed in a Phase I dose
escalation study of JOTROL™. The Phase I is conducted with healthy
volunteers in various ages and include a food effect arm. Per protocol, the
first patient cohort has been dosed and the study is continuing in January
and February of 2021. Top line data is expected to be available
in March 2021. The initial dose appear well-tolerated as the
escalation continues toward clinically relevant doses. JOTROL™ is, through
its unique bioavailability, the first and only resveratrol product that can
deliver a therapeutically effective dose without causing any severe
gastro-intestinal side effects. JOTROL™ is a platform product that is
expected to be an effective treatment in many rare diseases such as
ataxias, lysosomal storage disorders and mitochondrial diseases. Building
on the positive scientific review and funding from NIA JOT is also in
preparation of a Phase II trial for treatment of Mild Cognitive Impairment
(MCI).
"We have been
able to move the Phase I trial forward very quickly after we received
funding from the NIA, $1.76 M, and equity investors, $1.2 M, by
setting up clinical material manufacturing through Catalent Pharma
Solutions and contracting with Syneos Health Phase I unit in Miami,
Florida. We are assuming positive Phase I results, which will be a Proof Of
Concept of our product and have started preparations for Phase II trials in
MPS-1, Friedreich's ataxia and MELAS in addition to MCI study preparation.
We have presently cash covering us through 2021 and are targeting
additional financing through an equity raise, possible partnering as well
as utilizing non-dilutive funding sources to be able to start several Phase
II trials later in 2021," stated Christer Rosén, Chairman and CEO.
"I am very pleased
with our progress and excited to be designing efficacy trials in several
diseases. Key benefits of a platform product like JOTROL™ is that the Phase
I trial results can be cross-referenced for any Phase II trials involving
JOTROL™ contributing to a very fast and cost-effective way of achieving
Phase II study results. There are already human trials executed with
nutritional grade resveratrol in several diseases that have shown benefits,
although with GI tolerability issues, that gives us confidence for successful
outcomes in multiple diseases. With financing in place, we may have
positive clinical results already by mid 2022," stated Marshall
Hayward, CSO.
For more information
about Jupiter Orphan Therapeutics and JOTROLTM, visit www.jupiterorphan.com.
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