Full Press Release Details
• Significant reduction of key cytokines IL-31, IL-36α, and IL36γ
• 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 — 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. To request an interview with Turn Therapeutics’ Founder and CEO, Bradley Burnam, contact media@turntherapeutics.com . To invest via limited online offering, click here . 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.
WESTLAKE VILLAGE, Calif., Aug. 5, 2024 — 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.
To request an interview with Turn Therapeutics’ Founder and CEO, Bradley Burnam, contact media@turntherapeutics.com . To invest via limited online offering, click here .
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.