Germantown, MD, USA (October 08, 2020) – Amarex Clinical Research, LLC, an NSF International company client, Amytrx Therapeutics ("Amytrx"), recently initiated clinical testing of their anti-inflammatory therapeutic product AMTX-100 for dermatological diseases and conditions with the enrollment of patients in a first-in-man Phase 1/2b study for treatment of mild to moderate atopic dermatitis. Amarex wrote and submitted the IND application for Amytrx and is now managing the clinical trial.
Preclinical safety studies in the IND cover several other inflammatory skin conditions including psoriasis, rosacea, acne, herpes type 1 and 2, and shingles.
Amarex President & CEO, Dr. Kazem Kazempour, said, "Atopic dermatitis is a chronic inflammatory skin disorder that affects all age groups and can cause physical and psychological discomfort and pain. Amytrx's topical peptide, AMTX-100 CF, is a new prospective treatment targeting this significant unmet medical need. We are excited to understand more about the potential for this drug to benefit patients afflicted with inflammatory skin conditions. We hope to continue working with Amytrx for many years to come."
The trial initiated in March 2020 and is currently being conducted at four clinical sites in the United States. Completion of full enrollment is anticipated in 1Q 2021.
"AMTX-100's anti-inflammation peptide is an entirely new therapeutic with immense potential to yield safer and more effective dermatologic therapies. The data for atopic dermatitis generated thus far is very encouraging. We also see promising preclinical test results for a wide range of diseases resulting from inflammation that represent significant unmet medical needs," said Dr. Matt Gonda, Amyrx's CEO, President, & Co-founder.
Amytrx's product is a first-in-class cell-penetrating peptide bioengineered entirely from human protein sequences. The mechanism of action of AMTX-100 is well understood. It modulates chronic and acute inflammation by targeting importins, which are nuclear transporters of large inflammatory transcription factors that promote the production of inflammatory cytokines, chemokines growth factors and metabolic products by a natural process to restore immune and metabolic balance.
About Amytrx Therapeutics, Inc.
Amytrx is a clinical-stage biopharmaceutical company advancing the next generation of new anti-inflammatory peptide therapies for patients suffering from chronic inflammatory diseases. We are a group of dedicated scientific, medical, and business professionals all deeply committed to positively transforming the health and lives of patients. The company's breakthrough therapeutic platform, AMTX-100, is a first-in-class anti-inflammatory peptide bioengineered from human protein sequences that modulate the immune system by a natural process, reducing pathogenesis in a range of inflammation-induced conditions. This completely novel approach to restoring immune balance harnesses significant potential for safer and more effective treatments across a range of diseases where medical need remains. Our business strategy includes exploring collaborative opportunities with pharmaceutical and biotechnology partners, as well as clinical and research organizations, to advance new or complementary therapies for chronic diseases where excessive inflammation or metabolic imbalances play key causative roles. For more information on the company, please visit www.amytrx.com.
VP, Corporate Affairs
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive 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. Amarex provides high quality and cost-efficient services. For more information visit www.amarexcro.com.
Patrick J. Burke
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