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Highlights
- Syntara receives fast track status for SNT-5505
- Promising results continue in myelofibrosis Phase 2 trial
- Final results and pivotal study discussions expected in 2025
Clinical-stage biopharmaceutical company Syntara (ASX:SNT) has reported significant progress in its mission to address myelofibrosis, a rare and serious type of blood cancer. The company’s treatment candidate, SNT-5505, is showing promising clinical performance as part of an ongoing Phase 2 trial, coupled with a major regulatory milestone from the US Food and Drug Administration (FDA).
FDA Fast Track Opens Doors
In a noteworthy development, the FDA has granted fast track designation to SNT-5505. This designation is designed to facilitate the development and expedite the review of treatments that address serious medical conditions and unmet needs. It also enables more frequent interactions with the FDA and offers the opportunity for accelerated approval processes.
Strong Interim Results in Combination Therapy
Syntara’s Phase 2 trial evaluates SNT-5505 in combination with ruxolitinib (RUX), targeting patients with myelofibrosis who have had a limited response to existing treatment options. The disease, which disrupts bone marrow function and blood cell production, leads to symptoms such as anemia, enlarged spleen, and increased risk of infection.
Patients enrolled in the study have been undergoing combination treatment for an average of three years. The interim results indicate continued improvement in both symptom relief and spleen volume reduction—key markers of treatment efficacy. These findings support the potential for SNT-5505 to enhance long-term outcomes when used alongside Janus kinase (JAK) inhibitors.
According to Syntara, these improvements are considered novel compared to other drugs currently in the market or late-stage development. This not only highlights the differentiated mechanism of SNT-5505 but also strengthens its positioning in a competitive treatment space.
The company expects the final three patients in the study to complete 12 months of treatment by the third quarter of 2025. After this, final results will be disclosed, setting the stage for a pivotal Phase 2c/3 trial.
Syntara also intends to advance discussions with the FDA to define the next steps in its clinical roadmap. Simultaneously, the company is exploring potential collaborations with regional and global partners to support the continued development and commercialization of SNT-5505.
With compelling interim data and regulatory momentum, Syntara (SNT) is steadily progressing towards a potential new therapeutic option for patients affected by myelofibrosis.
