Turn Therapeutics has announced positive data from a biomarker study of its topical candidate, GX-03, indicating significant immunological inhibitory effects in an eczema model. The study, which assessed GX-03's impact on cytokine levels in C57BL/6 mice, revealed substantial reductions in key cytokines implicated in atopic dermatitis (AD). These findings suggest GX-03 could offer a novel approach to managing AD by targeting the underlying immunological pathways.
Cytokine Inhibition
The research demonstrated that GX-03 significantly inhibited several cytokines known to play a role in dermatological conditions. Notably, IL-31, a cytokine heavily implicated in the pathogenesis of eczema and AD, showed a 67.7% reduction compared to placebo (p < 0.000001). Additionally, IL-36α and IL-36γ, cytokines associated with various dermatological pathologies and psoriasis, respectively, were also significantly inhibited, with reductions of 50% (p < 0.000003) and 49% (p < 0.0000001).
Impact on Disease Severity
The study also evaluated the impact of GX-03 on disease severity using the Investigator's Static Global Assessment (ISGA) scale, a 5-point rating scale recommended by the FDA for assessing AD severity. Following pretreatment with GX-03, the ISGA score was significantly reduced to 0.8, indicating clear to almost clear skin, compared to a score of 2.4 with placebo, which represents mild-moderate eczema.
Future Clinical Development
"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. The company plans to advance GX-03 into clinical trials, emphasizing its non-steroid, non-injectable nature and established safety history. GX-03 has already received FDA clearance in other indications, confirming its non-cytotoxicity and lack of sensitization potential.
