Breakthrough Results from the BETTER Trial
Isarna Therapeutics has achieved groundbreaking results from its Phase 2 BETTER trial, showcasing the effectiveness of innovative antisense therapy designed to block TGF-?2 production. This pioneering treatment indicates significant promise in addressing concerns related to retinal fibrosis in patients suffering from wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Positive Impact on Patients
The trial, presented at a respected annual meeting focused on ophthalmology, highlighted the performance of ISTH0036, a selective antisense oligonucleotide. Patients receiving the therapy via intravitreal injections every eight weeks demonstrated not only stable but improved best-corrected visual acuity (BCVA). Additionally, there were observed anatomical improvements in the retina, including a decline in central retinal thickness (CRT) across all patient demographics.
Advantages over Existing Treatments
What stands out about ISTH0036 is its ability to significantly reduce the volume of hyperreflective material associated with fibrosis in patients with nAMD, contrasting sharply against the outcomes of traditional anti-VEGF therapies. DME patients also benefited from the treatment, experiencing reduced intraretinal fluid volume irrespective of prior anti-VEGF treatments. The overall safety profile was positive, with intraocular pressure remaining stable throughout the study.
Expert Insights from Isarna’s Team
Prof. Marion R. Munk, Chief Medical Officer of Isarna Therapeutics, expressed enthusiasm about the trial's findings, emphasizing ISTH0036's potential to redefine care for those at risk of progressive vision loss. As the medical community seeks better solutions for conditions like nAMD and DME, the advantages presented by this antifibrotic agent offer a new path forward.
Future Steps for Isarna Therapeutics
Following these promising results, Isarna Therapeutics plans to engage with regulatory bodies in the US and Europe, aiming to escalate ISTH0036 into the next phases of clinical development. The aim is to facilitate the transition towards Phase 2b and Phase 3 pivotal clinical studies, building upon the strong foundation established by the BETTER trial.
Exploring ISTH0036 and the BETTER Trial Further
ISTH0036 represents a novel approach to combating retinal diseases, targeting TGF-?2, a vital cytokine involved in disease progression linked to fibrosis. The BETTER trial not only tested the drug on treatment-naïve patients but also included those previously treated with anti-VEGF therapy, providing a well-rounded examination of its effectiveness across different patient groups.
About Isarna Therapeutics
Isarna Therapeutics stands at the forefront of antisense oligonucleotide technology and therapeutic targeting, focusing on the TGF-? signaling axis, which plays a crucial role in a myriad of diseases. The company is actively advancing its pipeline, with ISTH0036 leading the charge in late-stage clinical development for significant retinal conditions.
Contacting Isarna Therapeutics
For inquiries, individuals can reach Isarna Therapeutics via email at info@isarna-therapeutics.com. Media representatives can contact Trophic Communications, reaching out to Gretchen Schweitzer or Desmond James at +49 151 678 59086 or email at isarna@trophic.de.
Frequently Asked Questions
What is ISTH0036?
ISTH0036 is an investigational antisense oligonucleotide aimed at reducing the production of TGF-?2, targeting retinal diseases like wet AMD and DME.
What did the BETTER trial demonstrate?
The BETTER trial showed that ISTH0036 effectively stabilized or improved visual acuity and reduced retinal thickness in patients.
How often is ISTH0036 administered?
Patients receive ISTH0036 through intravitreal injections every eight weeks.
What are the safety findings from the trial?
The treatment was well tolerated, with stable intraocular pressure throughout the study.
What are Isarna’s next steps for ISTH0036?
Isarna Therapeutics plans to discuss trial results with regulators and move toward Phase 2b and Phase 3 studies.
