- Significant reduction of key cytokines
IL-31, IL-36α, and IL-36γ
- ISGA mean score of 0.83 with GX-03 topical
pre-treatment vs 2.44 placebo, comparable to biologics
- Company projects phase 1b/2 efficacy trials to begin in 2025
WESTLAKE
VILLAGE, Calif., Aug. 5, 2024
/PRNewswire/ -- Turn Therapeutics, a pharmaceutical and
medical device company focused on immunology, advanced wound care,
and dermatology, announced today positive data results of GX-03 in
a biomarker study intended to measure its immunological inhibitory
effects during eczema induction.
The study evaluated the immunological inhibitory effects of the
topical application of Turn Therapeutics' candidate, GX-03, in an
eczema model using C57BL/6 mice and a well-established NIH
pre-treatment protocol. After a four-day pretreatment period with
GX-03, disease induction was carried out over the following three
days. Cytokine levels and average disease severity scores were then
assessed using the ISGA (Investigator's Static Global Assessment)
scale across all groups.
GX-03 showed inhibition of key cytokines implicated in multiple
dermatological conditions, including atopic dermatitis. IL-31
levels, considered to play a significant role in the pathogenesis
of eczema and atopic dermatitis (AD), showed a reduction of 67.7%
vs placebo [p-value (1.12×10−6)]. IL-36α and IL-36γ also
demonstrated significant inhibition: 50% [p-value
(3.0×10−6)] and 49%
[4.35×10−8], respectively. IL-36α is a key cytokine
driving a spectrum of dermatological pathologies while IL-36γ is
largely associated with multiple forms of psoriasis.
The ISGA is a 5-point rating scale that is recommended by the US
Food and Drug Administration for assessing the severity of AD. ISGA
success is a widely used endpoint in AD clinical studies. Following
a pre-treatment regimen, Turn Therapeutics' candidate demonstrated
a significant reduction in ISGA score to 0.8, indicating clear to
almost clear, compared to 2.4 with placebo, or mild-moderate
eczema.
"This inhibition data is especially notable given that it was
achieved via pre-treatment prior to disease induction, indicating
powerful dermal penetration and lasting effects," said Bradley Burnam, founder and CEO of Turn
Therapeutics. "With the data produced over the past couple of
months detailing the potential efficacy in eczema, we look forward
to entering the clinic with this non-steroid, non-injectable asset
with a lengthy safety history in humans."
The results of the study were recently featured in Dermatology
Times. Turn Therapeutics' GX-03 formulation has a well-established
safety history and has received FDA clearance in other indications
that confirm its non-cytotoxicity and lack of sensitization
potential.
For more information, please see turntherapeutics.com. To
request an interview with Turn Therapeutics' Founder and CEO,
Bradley Burnam, contact
media@turntherapeutics.com. To invest via limited online offering,
click here.
About Turn Therapeutics
Turn Therapeutics is a
pharmaceutical and medical device company focused on advanced wound
and dermatologic care. Turn's technology targets broad indications
with few safe or effective options, such as moderate to severe
eczema and onychomycosis. Leveraging the guidance and data produced
by medical experts, Turn's innovative flagship formula continues to
suggest remarkable efficacy for a variety of indications.
Visit turntherapeutics.com.
Forward-looking Statements
The statements contained
herein may include prospects, statements of future expectations,
and other forward-looking statements that are based on management's
current views and assumptions and involve known and unknown risks
and uncertainties. Actual results, performance, or events may
differ materially from those expressed or implied in such
forward-looking statements.
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SOURCE Turn Therapeutics