Amytrx and Amarex Clinical Research, LLC, an NSF company, announced they are initiating the Phase II clinical trial on atopic dermatitis (AD) using Amytrx’s therapeutic AMTX-100 CF3.
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AMTX-100 CF3 is a unique peptide in a topical ointment formulation that readily penetrates the skin. It is made of 87% water and leaves no smell or residue. Phase I data in AD patients showed that half of the patients in a seven-day treatment protocol achieved total or almost total clearance of treated atopic dermatitis lesions after only one week of AMTX-100 CF3 administration, and more significantly, the improvement trend continued even after end of treatment and through the 2-week follow-up period.
We are encouraged by the biological impact on patients in this study for their treatment.
Amytrx specializes in safe and effective anti-inflammatory peptide therapeutics for patients suffering from chronic inflammatory and autoimmune diseases. AMTX-100 CF3, its leading drug candidate, is known for its ability to transport across membranes, address inflammation and modulate immune mediated diseases instead of simply inhibiting inflammation.
“We are encouraged by the biological impact on patients in this study for their treatment with a therapeutic we believe is not only effective, but is supportive of compliance,” said Randy Riggs, Chief Business Officer at Amytrx. “We’re excited by the potential of our peptide therapeutic that doesn’t inhibit, but safely modulates inflammation to bring about the resolution of immune-mediated diseases.”
Working together, Amytrx and Amarex successfully completed the drug’s Phase I human safety and exploratory efficacy trial in 2021. Amytrx is initiating the Phase II trial in adult subjects with mild to moderate atopic dermatitis using transcriptomic mapping. The study will evaluate safety and efficacy of treatment over 28 days.
Amarex designed this study, submitted the IND application for FDA approval, diligently guided Amytrx through the Phase I trial, and is poised to continue leading the product through FDA trials until it is approved for market.
“We are pleased that our expert solutions and dedicated staff helped Amytrx meet this critical milestone on time.” said Dr. Kazem Kazempour, President and CEO at Amarex. “The FDA gave us the green light to proceed with this adaptive design trial transitioning from the Phase I part illustrating our commitment to helping sponsors accelerate their development of safe and innovative patient treatments. Amarex is honored to be working with Amytrx on their ground-breaking anti-inflammatory therapy.”