arGentis Pharmaceuticals, LLC is a privately-held diversified biopharmaceutical company dedicated to the licensing, development and commercialization of novel classes of therapies to treat chronic diseases in autoimmunity and ophthalmology. arGentis’ drug R&D programs are focused on treating underlying mechanisms of inflammatory conditions through utilization of oral and transdermal compounds. Commercializing technology from research institutions' laboratories provides arGentis with:
- A continuous pipeline of products based on world-class research.
- Therapies that have human and efficacy data which reduces clinical and regulatory risk.
- Lowered development cost given due to completed basic research, preclinical and clinical development work.
- Streamlined time to market or more expeditious out-licensing opportunities given the previous clinical data.
- Repositioning tested compounds will reduce formulation development time and simplify development of CMC data.
- Access to thought leaders within chosen therapeutic classes.
arGentis is developing ARG201, a treatment for systemic scleroderma (SSc), an autoimmune disease leading to widespread collagen build up on the skin and within the vascular structures of internal organs, resulting in co-morbidities such as pulmonary hypertension, kidney and gastrointestinal track failure, pulmonary fibrosis and death. SSc is an orphan disease with approximately 100,000 patients each in the U.S. and Europe. The mechanism of action of ARG201 is to induce immune tolerance, whereby the body ceases attacking type I collagen, a primary autoantigen in SSc. ARG201 has completed a 168-patient Phase II clinical trial with very promising results. There are currently no approved therapies for the underlying cause of SSc. Median survival from diagnosis is approximately 11 years. ARG201 has been granted orphan drug status in the US by the Federal Drug Administration (FDA) and in the EU by the European Medicines Agency (EMEA). The company is also pursuing Fast Track Drug Designation in the US. arGentis is preparing for a confirmatory Phase IIb trial to commence in 2011.
arGentis recently announced that it has expanded its drug R&D pipeline through a collaboration with the University of Tennessee Health Science Center (UTHSC) and the Veterans Affairs Medical Center of Memphis (VAMC). The parties will initiate the first human clinical evaluation of an oral altered peptide ligand (APL), ARG301, in a Phase I study of Rheumatoid Arthritis patients. The Phase I trial commenced March, 2010. ARG301, licensed by arGentis from the University of Tennessee Research Foundation, is a synthetic peptide, which in animal studies appears to down regulate autoimmunity to Type II collagen (CII), a known autoantigen in RA. Investigators at the UTHSC and Memphis VAMC developed the therapy and have received a Clinical Merit Review Grant from the Department of Veterans Affairs to conduct the trial.
We have also licensed the intellectual property to three therapies treating separate populations of patients having dry eye syndrome (DES), a condition that affects at least 20 million Americans and over 100 million people in the developed world. DES can be a serious condition, which, if left untreated, can damage ocular structures. arGentis intends to file an Investigational New Drug (IND) application(s) in 2010 for the lead DES treatment, ARG101.