SAN
DIEGO, March 29, 2024 /PRNewswire/ -- PassPort
Technologies, Inc. (PPTI), based in San
Diego, a clinical-stage drug and medical device development
company, today announced positive interim results from the Phase 1
(Part A) clinical trial of Zolmitriptan PassPort® utilizing its
proprietary transdermal microporation system for the treatment of
acute migraine. Zolmitriptan is an FDA-approved prescription
medication used for treating migraine symptoms.
Zolmitriptan PassPort® demonstrated
tolerability and rapid delivery of zolmitriptan.
Zolmitriptan PassPort®, a needle-free combination system
consisting of a microporation device and zolmitriptan patch, was
applied on the individual's upper arm to deliver zolmitriptan into
the systemic circulation via micropores painlessly created in the
skin.
The open-label, randomized, crossover study consisting of 32
healthy volunteers tested the tolerability and pharmacokinetics of
Zolmitriptan PassPort® with 3 different doses (0.75 mg, 1.5 mg, and
3.0 mg) compared to oral administration of 2.5 mg zolmitriptan.
Zolmitriptan PassPort® was well-tolerated with no serious
adverse events. Zolmitriptan was detected in the plasma only 2
minutes after Zolmitriptan PassPort® administration, much faster
than 15 minutes seen for oral administration. The relative
bioavailability of Zolmitriptan PassPort® was approximately 160 to
200% compared to oral zolmitriptan.
"We are pleased with the tolerability and pharmacokinetics of
Zolmitriptan PassPort® in Phase 1 Part A study. Our Zolmitriptan
PassPort® is expected to demonstrate significant advantages of
faster onset of action and higher pain relief for migraine patients
with severe nausea and patients who are non-responsive to oral
triptans. It will provide a Best-in-Class product option." said
President and CEO Tomoyuki
Fujisawa.
Part B study, currently underway, will evaluate the transdermal
administration of a single dose at alternative sites, the subject's
abdomen and upper thigh. The final results will be available to the
public in Q3 2024.
PPTI holds exclusive global rights to develop and commercialize
the Zolmitriptan PassPort® but intends to out-license for further
clinical development and commercialization.
About PassPort Technologies, Inc.
As a cutting-edge biotechnology entity, PPTI is committed to the
swift development and patient delivery of innovative
pharmaceuticals through the PassPort® system. The company aims to
constantly develop technologies that serve the pharmaceutical
industry and broader life sciences sectors. PPTI's mission is to
advance global health outcomes. Further details can be found at
https://passport-tech.com.
About PassPort® Technology
The PassPort® System integrates patented painless skin
microporation and dry patch formulation technologies to regulate
drug delivery through the micropores created in the skin. This
innovative system enables transdermal delivery of not only small
molecules but also peptides, proteins, and RNAs for therapeutics
and infection vaccines.
Forward-Looking Statement
Except for historical information, all the statements,
expectations, and assumptions contained in this Press Release are
forward-looking statements. Actual results may differ materially
from those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ
materially include: the early phase of the clinical trial; risks
associated with the drug development process; competition; reliance
on key personnel; and other risks described in other PassPort
Technologies, Inc. press releases and presentations.
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SOURCE PassPort Technologies, Inc.