Isarna Therapeutics Presents Update From Phase 2 BETTER Study in Wet AMD and DME at the EURETINA Meeting
Isarna Therapeutics presented an update from its ISTH0036 clinical development program and the ongoing BETTER Study at the EURETINA meeting in Hamburg, Germany on September 1st, 2022. Marion Munk, MD, PhD, FEBO, and the CMO of Isarna Therapeutics provided 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, according to Isarna. Dr. Munk discussed initial efficacy signals seen in patients at 1 month after 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,” said Rene Rückert, MD, MBA, and 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 (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 as the primary endpoint and improvement of visual acuity as a secondary endpoint during a treatment period of 7 months, followed by a 2-month safety followup. 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 4 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.
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.