Amytrx Therapeutics Comes Out of the Gate Strong with Lead Program AMTX-100, Clinical Development Plans image

Amytrx Therapeutics, Inc. is on the move.

Founded in 2014, Nashville-based Amytrx is developing novel therapies for inflammatory diseases with lead program AMTX-100 currently in clinical development for dermatologic indications.

AMTX-100 is 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

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," says Dr. Matt Gonda, Amyrx's CEO, President, and Co-founder, in a news release.

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," says 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," adds Randy Riggs, Amytrx's Chief Business Officer.