#China #Chengdu #Atopic Dermatitis #Technoderma #TDM-180935

Technoderma Medicines Successfully Completes Phase 2a Clinical Trial for TDM-180935 Ointment

On January 6, 2025, Technoderma Medicines, Inc. announced the successful completion of its Phase 2a clinical trial focusing on the efficacy and safety of TDM-180935 ointment for Atopic Dermatitis (AD). This randomized study, designated as NCT06363461, evaluated the ointment's performance over 8 weeks in patients suffering from this chronic skin condition.

Study Overview

The trial involved a total of 24 patients with mild to moderate AD, split into two groups receiving either 1% or 2% concentrations of TDM-180935, alongside a placebo group. The study was structured to comprehensively assess not only the efficacy, but also the safety, tolerability, and pharmacokinetics of the treatment. The results from the primary endpoint, which measured changes in the modified Eczema Area and Severity Index (m-EASI) at the end of the treatment period, indicated strong positive outcomes, particularly in the high-strength 2% TDM-180935 group.

The trial design also included an open-label pharmacokinetic (PK) substudy with an additional six patients, which further validated the findings. One notable response observed was that significant improvements were recorded across all active treatment groups. In fact, the study achieved a response rate where patients showed notable improvement in their AD symptoms as measured by the vIGA-AD score.

Safety Profile

Safety assessments revealed that the ointment was well-tolerated among participants with no serious adverse events reported. Of the 24 patients, only one participant in the placebo group exited due to a flare at the application site, underscoring the favorable safety profile of TDM-180935. Furthermore, measurable systemic exposure was minimal, an encouraging sign for its use on larger body surface areas often affected by AD.

Dr. Arthur P. Bertolino, Chief Medical Officer at Technoderma, commented, "The results from this study confirm the proof-of-concept for TDM-180935, leading us to favor the 2% formulation for further development in our AD program." He highlighted the selective advantages that TDM-180935, as a potent JAK1/Tyk2 small molecule inhibitor, may offer compared to existing treatments.

Significance of Results

Zengquan Wang, CEO of Technoderma Medicines, expressed his enthusiasm regarding the study's outcomes. He noted, "We are pleased with this clinical study confirming excellent toleration and minimal systemic absorption of TDM-180935 ointment. Demonstrating strong preliminary efficacy in the treatment of Atopic Dermatitis reinforces our aim to advance this promising program in our portfolio." This trial serves as validation for Technoderma's ongoing commitment to developing multiple innovative treatments for dermatologic diseases.

Future Directions

Technoderma is exploring further advancements in its pipeline, focusing on treatments for various skin conditions, including Psoriasis and Lupus Erythematosus. The successful results from the TDM-180935 trial not only pave the way for broader clinical applications but also enhance the company's position in the competitive healthcare landscape.

Conclusion

The completion of Technoderma's Phase 2a trial represents a significant step forward in addressing the challenges of treating Atopic Dermatitis, a condition that affects a substantial percentage of the global population. As the healthcare community watches closely, the potential of TDM-180935 as a leading topical treatment for AD is one that might significantly improve patients' lives, enabling enhanced skin health and quality of life for those affected by this chronic condition.