MUNICH--(BUSINESS WIRE)--Isarna Therapeutics will present an update from its ISTH0036 clinical development program and the ongoing BETTER Study at the EURETINA meeting in Hamburg, Germany on September 1st, 2022. Prof. Marion Munk, MD, PhD, FEBO, the CMO of Isarna Therapeutics and a renowned global retina specialist will provide initial positive safety results and efficacy signs from 18 patients treated in the study. To date, the trial has reported a good safety profile for ISTH0036 with no drug-related adverse events and no signs of intraocular inflammation. Prof. Munk will discuss initial efficacy signals seen in patients at one month post first treatment.
“Isarna values the opportunity to interact with other specialists in the field at the EURETINA conference and present the positive progress we have achieved in the BETTER trial,” commented Dr. Rene Rückert, MD, MBA, COO of Isarna Therapeutics. “We have now recruited a total of 23 out of the targeted 60 patients, with the trial on target to achieve full enrollment in the first quarter of 2023 and final data readout expected by the end of 2023.”
The BETTER Study is an ongoing parallel, two-segment Phase 2 open label clinical study to evaluate Isarna’s lead candidate ISTH0036 in patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The study aims to enroll as many as 30 patients for each indication and is being conducted by internationally renowned experts at clinical trial centers in Austria and India. The study’s objective is to evaluate ISTH0036 in these two indications and gain data that will enable the transition into a Phase2b/3 clinical trial.
The Phase 2 trial is gathering data on the reduction of retinal fluid and central macular thickness (CMT) as the primary endpoint and improvement of visual acuity (VA) as a secondary endpoint during a treatment period of seven months, followed by a two-month safety follow-up. The trial aims to explore the prevention of fibrosis and epithelial-mesenchymal transition as a key differentiator to currently approved anti-angiogenic therapies, mostly targeting Vascular Endothelial Growth Factors (VEGF). Furthermore, the durability of the antisense therapy ISTH0036 will be evaluated, which showed target suppression in preclinical models for more than four months. Patients selected for the trials will include both newly diagnosed, treatment naïve patients and those who have already been treated with anti-VEGF therapeutics.
Wet AMD causes reduced vision in the center of the eye and affects as many as 190 million people globally1. Macular edema occurs when there is abnormal leakage and accumulation of fluid in the macula from damaged, dysfunctional blood vessels in the retina. A common cause of macular edema is diabetes, which is the leading cause of irreversible blindness in mature adults in the U.S.2 Both diseases can be treated with a range of anti-VEGF drugs however, these therapeutics are not able to maintain visual acuity as many patients develop fibrosis during the disease progression.
Isarna has developed ISTH0036 to target the transforming growth factor-beta (TGF-β), a protein which is chronically elevated in ophthalmic, fibrotic, immunologic, and cancerous diseases. ISTH0036 suppresses TGF-β protein production via well-studied antisense mechanisms.
***
About Isarna
Isarna Therapeutics was built on profound knowledge in antisense oligonucleotide design and therapeutic development of this innovative compound class. Today, Isarna is developing a portfolio of antisense therapies targeting an emerging therapeutic field in human biology: TGF-β signaling. Precise modulation of TGF-β pathways using antisense therapy may result in safer and more effective treatment options for a broad range of indications. Currently, Isarna is focusing on ophthalmology; its lead compound, ISTH0036, has entered Phase 2 clinical development in the blockbuster indications wet AMD and DME. In addition, Isarna has established a portfolio of antisense compounds addressing three important isoforms of TGF-β to treat fibrotic liver disease, such as NASH, and various forms of cancer.
1 Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, et al. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013;1:e339–49.
2 Bressler NM. Age-related macular degeneration is the leading cause of blindness. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. PMID: 15108691.
