Open Enrollment Underway for Phase 2b Trial of Topical AMTX-100 CF3 in AD
The trial's primary endpoints include improvement in disease severity, reduction in symptoms, and assessment of treatment safety.
Amytrx Therapeutics is enrolling mild to moderate atopic dermatitis patients for its Phase 2b clinical trial of a topical formulation of AMTX-100 CF3.
Eligible adults interested in participating or learning more about the trial are encouraged to visit the ClinicalTrials.Gov listing # NCT04313400 or visit Amytrx Therapeutics' website at www.amytrx.com.
The Phase 2b clinical trial will continue to build upon a recent trial that has evaluated the safety and efficacy of AMTX-100 CF3 in a larger cohort of adult patients that has shown favorable efficacy bypassing the need for rescue steroid treatment. This randomized, double-blind, placebo-controlled study will be conducted at 8-10 clinical sites across the country. This study is seeking 60 participants to generate a 1:1 ratio between placebo and active arms of the study. The trial's primary endpoints include improvement in disease severity, reduction in symptoms, and assessment of treatment safety.
This clinical trial will include a 28-day treatment period with twice daily treatment and a 2-week follow-up assessment post-treatment to determine therapeutic efficacy. In addition, participants will receive a topical emollient 2-weeks prior to trial to exclude participants who may be impacted by a placebo effect. Precision medicine techniques will also be used to assess changes in the expression of genes involved in inflammation.
"We are thrilled to initiate the open enrollment for our Phase 2b clinical trial of AMTX-100 CF3," says Dr. Matthew A. Gonda, CEO of Amytrx Therapeutics, in a news release. "At Amytrx, we are committed to developing innovative therapies that can make a meaningful difference in the lives of patients. This trial represents a crucial step towards bringing a safe and targeted treatment option to adults suffering from atopic dermatitis, in addition to other chronic inflammatory skin diseases such as psoriasis, vitiligo, lupus, graft vs. host, and more."
AMTX-100 CF3 is an anti-inflammatory peptide that utilizes a novel untapped intracellular target to control inflammation.
The open enrollment for the Phase 2b clinical trial of AMTX-100 CF3 is now underway.
The current topical formulation of AMTX-100 CF3 being studied in the Phase 2b clinical trial provides an example of the various formulations available for novel anti-inflammatory peptide AMTX-100. Amytrx Therapeutics is actively exploring other delivery methods to cater to the diverse needs of patients across a variety of inflammatory diseases. These formulations include oral, injectable, nasal spray, and other options. This comprehensive approach underscores Amytrx Therapeutics' commitment to developing a range of therapeutic options that can effectively target inflammation and provide additional treatment strategies.