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Amytrx Therapeutics Emerges from Stealth to Develop Novel Therapies for Inflammatory Diseases with Lead Program AMTX-100 Currently in Clinical Development for Dermatologic Indications

  • AMTX-100 breakthrough anti-inflammatory peptide technology advancing first-in-class therapies for inflammatory, autoimmune, and metabolic diseases

 

  • FDA acceptance of topical AMTX-100 IND application for mild to moderate atopic dermatitis (eczema); Phase 1/2b clinical trial underway

 

  • Versatile formulations of AMTX-100 in preclinical development for additional indications with high unmet medical need; Program supported by excellent systemic and topical safety studies

 

NASHVILLE, TN, September 17, 2020 /PRNewswire/ -- Amytrx Therapeutics, Inc., (“Amytrx”), a clinical stage biopharmaceutical company advancing next-generation inflammation-targeting therapies, today launched from stealth to announce the company's novel therapeutic platform, clinical development plans, and preclinical program initiatives.

Founded in 2014, Nashville-based Amytrx is developing AMTX-100, a new anti-inflammatory therapeutic platform, which has broad potential in multiple inflammatory, autoimmune, and metabolic diseases.

Amytrx acquired the technology in an exclusive license of IP from Vanderbilt University, leveraging 25 years of scientific research developed in the lab of distinguished immunologist Dr. Jacek Hawiger, M.D., Ph.D., who is also a co-founder in the company. Post-licensing, Amytrx secured $11 million in Series A financing from prominent investors to advance a pipeline of best-in-class anti-inflammatory therapies for diseases with significant unmet medical need.

 

About AMTX-100

Amytrx's platform is a breakthrough therapeutic approach focused on reprogramming immune cell genomes. AMTX-100 is a first-in-class, cell-penetrating, anti-inflammatory peptide bioengineered entirely from human protein sequences. 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 and chemokines, by a natural process to restore immune and metabolic balance.

"AMTX-100's inflammation-targeting technology is an entirely new therapeutic approach with immense potential to yield safer and more effective therapies. By naturally modulating common and key pathways used to initiate inflammation, AMTX-100 has the ability to provide broad therapeutic activity without affecting important housekeeping genes essential for cell growth and viability, drastically minimizing side-effects and safety concerns seen with many small molecule and biologic anti-inflammatory drugs," said Dr. Matt Gonda, Amyrx's CEO, President, and Co-founder.

 

Clinical Pipeline

Amytrx has achieved several important milestones in early 2020, advancing a potentially best-in-class topical formulation of AMTX-100 into clinical development for dermatologic indications.

The company received FDA approval of its Investigational New Drug (IND) application for mild to moderate atopic dermatitis (eczema), initiating a Phase 1/2b clinical trial for this indication in March. Preclinical safety studies in the IND cover several other inflammatory skin conditions including psoriasis, rosacea, acne, herpes type 1 and 2, and shingles, potentially accelerating clinical development for these indications. The Phase 1 study is in progress in 25 eczema patients to evaluate the safety, tolerance and exploratory biological activity endpoints of a topical AMTX-100 cream formulation.

"Amytrx is using a revolutionary and broad-spectrum approach to treating inflammation with its cell-penetrating peptide platform. The clinical data for eczema generated thus far is very encouraging," said Dr. Dennis J. Carlo, Chief Executive Officer of Adamis Pharmaceuticals and Amytrx Board member.

 

Preclinical Program

Amytrx is looking to expand the AMTX-100 platform into additional indications.

 

The company's preclinical program is focused on developing the compound in a variety of injectable, oral, eye drop and nasal spray formulations to enhance specificity and safety of therapeutic delivery for systemic or high-concentration localized delivery. "Existing in vivo preclinical studies indicate excellent systemic and topical safety profiles and strongly support the therapeutic benefit of AMTX-100 in a range of disorders where inflammation or metabolic stressors form the underlaying basis of the condition," said Randy Riggs, Amytrx's Chief Business Officer.

 

About Amytrx Therapeutics

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 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

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Amytrx Contact:

Maya Frutiger

VP, Corporate Affairs

Email: mfrutiger@amytrx.com

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Amytrx Therapeutics, Inc.

102 Woodmont Blvd | Suite 243 Nashville, TN 37205

400 Riverhill Business Park | Suite 410 Birmingham, AL 35242

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