NASHVILLE, June 28, 2023 /PRNewswire/ — Amytrx Therapeutics, an emerging pharmaceutical company specializing in innovative anti-inflammatory therapies, is pleased to announce the open enrollment for its highly anticipated Phase 2b clinical trial of a topical formulation of AMTX-100 CF3, a groundbreaking anti-inflammatory peptide therapeutic designed to treat patients suffering from mild to moderate atopic dermatitis. This milestone marks a significant step forward in the development of advanced treatment options for individuals affected by this chronic and debilitating skin condition.
The trial’s primary endpoints include improvement in disease severity, reduction in symptoms, and assessment of safety.
Atopic dermatitis, also known as eczema, affects millions of adults worldwide, causing intense itching, redness, and dry skin (1). Despite the availability of various treatment options, there remains an unmet need for more effective and safer therapies. With this topical formulation of AMTX-100 CF3, Amytrx Therapeutics aims to revolutionize the treatment landscape and offer hope to those living with atopic dermatitis.
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,” said Dr. Matthew A. Gonda, CEO of Amytrx Therapeutics. “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.”
Amytrx Therapeutics has invested years of research and development into the creation of AMTX-100 CF3. This unique topical formulation of their anti-inflammatory peptide has shown promising results in preclinical and clinical studies. AMTX-100 CF3 utilizes a novel untapped intracellular target to control inflammation. The company believes that AMTX-100 CF3 has the potential to provide durable relief, enhance quality of life, and minimize the burden of this chronic condition with a revolutionary approach that interacts with a key checkpoint in the initiation of inflammation.
The open enrollment for the Phase 2b clinical trial of AMTX-100 CF3 is now underway. 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 company welcomes collaboration with research institutions that wish to contribute to advancing the knowledge and treatment of other inflammatory skin disorders.
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.
About Amytrx Therapeutics
Amytrx Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering the first anti-inflammatory human peptide platform (AMTX-100) yielding the potential for vastly optimized, cutting-edge therapies that safely alter the course of chronic inflammation and metabolic dysfunction to prevent and treat some of the world’s most debilitating diseases. For further information, please visit www.amytrx.com.
Kapur, S., Watson, W., & Carr, S. (2018). Atopic dermatitis. Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 14(Suppl 2), 52. https://doi.org/10.1186/s13223-018-0281-6
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