Syntara Limited Reports Promising Interim Results for SNT-5505 in Myelofibrosis Study

Syntara Limited, a prominent clinical-stage drug development firm based in Australia, has recently announced encouraging interim results from its Phase 2 clinical trial evaluating SNT-5505. This investigational treatment, which is to be administered in combination with ruxolitinib (RUX), targets patients suffering from myelofibrosis (MF), a serious condition that can severely impact the bone marrow's ability to produce blood cells. The interim findings were shared at the 66th American Society of Hematology (ASH) annual meeting on December 10, 2024.

Interim Results Overview

The ongoing Phase 2 study evaluates a dosage of 200 mg of SNT-5505 taken twice daily alongside a stable dose of RUX. Notably, the results have presented a promising opportunity for those with MF by demonstrating both positive tolerability and a consistent improvement in symptoms and spleen volume over time. The data showcased that up to 46% of evaluable patients saw a 50% reduction in their Total Symptom Score (TSS50) at just 12 weeks, which remarkably increased to 80% by 38 weeks of treatment. This improvement is considered substantial in clinical studies focused on MF.

Clinical Efficacy Demonstrated

The analysis also revealed that 30% of evaluable patients experienced a clinically meaningful reduction in spleen volume, with a significant 20% achieving a more substantial 35% reduction. These clinical endpoints hold immense significance for myelofibrosis patients, especially those who have had limited responses to current standard treatment options.

Notably, the ongoing improvement in spleen volume and reduction in symptom severity over the treatment period is a pioneering finding that distinguishes SNT-5505 from existing therapies. Such sustained benefits are crucial for enhancing long-term outcomes for MF patients.

Professor Claire Harrison, a specialist in myeloproliferative neoplasms at Guy's and St Thomas' NHS Foundation Trust, highlighted the promising safety profile of SNT-5505, emphasizing its potential to offer long-term relief for patients suffering from myelofibrosis. “This interim data not only confirms the excellent safety profile of SNT-5505 but also suggests that it may yield long-lasting effects on the disease as we observe notable improvements over nine months,” she commented.

Safety Profile and Future Plans

Syntara's interim data has also suggested that SNT-5505 is well tolerated, with no treatment-related serious adverse events reported. This profile is particularly encouraging since many existing therapies for MF are associated with considerable side effects.

Company CEO Gary Phillips stated, “The emerging results indicate that SNT-5505 could be a groundbreaking treatment, providing continued and durable benefits as the treatment period extends. This differentiates our drug from others on the market and reinforces the importance of symptom reduction, which the FDA closely monitors.”

Looking ahead, Syntara Limited plans to discuss the trial's design for a pivotal Phase 2c/3 study with the FDA, following the collection of further data by March 2025. The company is also anticipating that intermediated data will continue to reinforce the drug's potential while paving the way for collaboration with global and regional partners.

Conclusion

As Syntara Limited pushes forward in the evaluation of SNT-5505, the early findings serve as a beacon of hope for many suffering from myelofibrosis. With the expectation of further interim results being disclosed in the first half of 2025 and final data later that year, the medical community eagerly awaits more comprehensive insights into this innovative therapy. Syntara continues to leverage its expertise in drug development to address the critical needs within the realm of blood cancers and related conditions, potentially transforming the landscape of myelofibrosis treatment.