MUNICH--(BUSINESS WIRE)--Isarna Therapeutics, a leader in TGF-β targeted antisense therapeutics, today announced that it has submitted a Clinical Trial Authorization (CTA) application with the German Regulatory Authority to begin human studies on its lead program ISTH0036, a selective TGF-β2 antisense oligonucleotide. TGF-β2 is considered a prime disease driver in major ophthalmic diseases such as glaucoma, secondary cataract, and proliferative vitreoretinopathy.
“Glaucoma is the leading cause of irreversible blindness worldwide. By targeting TGF-β2 we believe that ISTH0036 represents an important innovative and so far unexplored new approach to stopping and potentially modifying the course of the disease in its advanced stages and, therefore, it addresses a high unmet medical need,” stated Dr. Philippe Calais, CEO of Isarna. “We expect to begin studies in the first half of 2015 and are seeking funding to advance this as well as our lead TGF-β isoform specific programs in fibrosis and oncology through the proof-of-concept stage.”
Dr. Calais continued, “Isarna made significant progress during the course of 2014, as it was only a year ago that we announced our agreement with Santaris providing us with exclusive access to their LNA chemistry technology, and today we announce our first CTA filing for a major disease in ophthalmology.”
ISTH0036 is a modified antisense oligonucleotide selectively targeting TGF-β2. TGF-β (Transforming Growth Factor beta) plays an important role in key pathways such as cell proliferation, cell differentiation, immune response and tissue modeling. Because TGF-β is chronically elevated in many diseases, including ophthalmic and fibrotic diseases and cancer, and involved in their pathophysiologies, it is an extremely versatile drug target throughout the body. Preclinical studies have demonstrated that ISTH0036 is highly potent and shows selective target engagement (TGF-β2 messenger RNA downregulation) consistent with long-lasting relevant tissue uptake.
About Isarna Therapeutics
Isarna Therapeutics has an unmatched commitment to developing selective TGF-β inhibitors to fight cancer and to effectively treat ophthalmic and fibrotic diseases. We are advancing a unique pipeline of novel oligonucleotides and combination modalities to transcend clinical response and improve patient outcomes. www.isarna-therapeutics.com. Isarna is headquartered in Germany, and registered as a Dutch BV as well as a U.S. Corporation.