GX-03 Demonstrates Encouraging Safety as Development Continues

Turn Therapeutics' investigational topical therapy GX-03 continues to demonstrate an encouraging safety and tolerability profile as the company advances its ongoing phase 2 clinical trial in atopic dermatitis, according to Bradley Burnam, founder and CEO of Turn Therapeutics.

Speaking with Dermatology Times, Burnam highlighted interim findings from the first 50 patients enrolled in the study, emphasizing the absence of treatment-related serious adverse events and discontinuations due to adverse events. He also outlined the company's plans to meet with the FDA before trial completion to discuss the most efficient development pathway for GX-03.¹

Encouraging Interim Safety Findings

Burnam noted that GX-03's safety profile has been reassuring thus far, pointing out that the formulation has previously been used in thousands of individuals for other FDA-cleared indications. Although this prior experience supported a favorable tolerability profile he said the interim phase 2 data have provided additional validation in a randomized, controlled trial.¹

Among the first 50 participants, who applied GX-03 two to three times daily for 8 weeks, investigators reported no discontinuations due to adverse events and no treatment-related serious adverse events. Burnam said these findings support the potential for a therapy that combines meaningful efficacy with a favorable safety profile.

"If you can get safe and powerful into one treatment, I feel like you have the opportunity to be first line," Burnam said.

Regulatory Strategy and Next Steps

Rather than waiting for completion of the phase 2 trial, Turn Therapeutics is preparing to meet with the FDA to discuss the most efficient path forward for GX-03.

Burnam said the company plans to publish the interim findings while simultaneously engaging the FDA on the therapy's development strategy. He added that Turn Therapeutics intends to ask the FDA to consider the existing safety database when evaluating the investigational therapy.¹

"Our goal is to get this product to their toolbox as quickly as possible," Burnam said.

Adaptive Trial Design Intended to Strengthen Development

Burnam also highlighted the adaptive design of the ongoing phase 2 study, explaining that insights generated during the first stage have informed modifications intended to strengthen the second stage.

According to Burnam, these adaptations include refinements based on potential biomarkers, patient stratification, and balanced enrollment across disease severity groups. He emphasized that the objective of an adaptive trial is to use emerging clinical data to optimize study design and generate more meaningful evidence rather than simply modifying the study protocol.

Burnam credited the company's clinical and regulatory advisors with helping guide these adaptations as GX-03 continues through development.¹

References

• Turn Therapeutics announces final stage 2 design and data-driven expansion of GX-03 phase 2 program in atopic dermatitis. News release. Turn Therapeutics. July 7, 2026. Accessed July 8, 2026. https://ir.turntherapeutics.com/news-releases/news-release-details/turn-therapeutics-announces-final-stage-2-design-and-data-driven