Amarex Clinical Research, LLC Guides Its Client to Phase II of FDA Trials
GERMANTOWN, Md., June 9, 2022 /PRNewswire/ -- Amytrx and Amarex Clinical Research, LLC, an NSF company, today announced they are initiating the Phase II clinical trial on atopic dermatitis (AD) using Amytrx's therapeutic AMTX-100 CF3.
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.
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."
Based on the safety profile of AMTX-100 CF3 in the Phase I/II, Amytrx plans to bridge into adolescent and juvenile subjects during its Phase II. Amytrx is actively researching AMTX-100 use in additional indications and collaborating with institutions on its leukocyte targeted cell-penetrating peptide delivery platforms to treat other unmet medical needs in inflammation, autoimmune disorders and cancer.
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.
Amarex Clinical Research, LLC (www.amarexcro.com), an NSF company, is a global, full-service Contract Research Organization (CRO), whose leadership has significant expertise conducting biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in project management: Phase I-IV, BE/BA, PK/PD; regulatory affairs: FDA applications and meetings, applications to international health authorities, GxP compliance audits; clinical operations; adaptive study designs; statistical analysis, data management; medical monitoring; safety and pharmacovigilance; and general consulting. Amarex can take your product through the entire approval process from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information, visit www.amarexcro.com.
NSF (nsf.org) is an independent, global organization that facilitates standards development, and tests and certifies products for the food, water, health sciences, and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With operations in 180 countries, NSF is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality, and Indoor Environment.
NSF's health sciences services include training and education, consulting, clinical research, regulatory guidance, corporate compliance and, separately, auditing, GMP and GLP analytical testing, DNA testing, certification, and R&D for the pharma biotech, medical device, and dietary supplement industries throughout the product lifecycle.
SOURCE Amytrx Therapeutics