Hi all,
Just reiterating data , and will simplify it at the end.
Syntara Limited (ASX:SNT), a clinical-stage drug development company, is pleased to announce positive interim data from its ongoing Phase 2 clinical trial evaluating SNT-5505 (200 mg BID) in combination with ruxolitinib (RUX) for the treatment of myelofibrosis (MF). The interim results suggest that SNT-5505 has potential as a breakthrough therapy for MF and are being presented today at the 66th American Society of Hematology annual meeting (ASH). Further interim data will be released in Haha 2025 and final data in 2H 2025.
The interim data suggests that SNT-5505 compares favourably thus far to other drugs being trialled for MF demonstrating excellent tolerability and improvements in symptoms and spleen volume that increase over time.
This is in line with the anticipated disease modifying effects of a pan-LOX inhibitor that works to improve the bone marrow microenvironment and inhibits a growth factor receptor (PDGFR-) that regulates cell expansion and division. This is encouraging, particularly given the trial patient population with a suboptimal response to existing standard of care and a high disease burden. Despite long prior RUX usage, most patients had high symptom scores and enlarged spleens at their entry into the trial.
At 12 weeks of treatment, 46% of evaluable patients achieved a 50% improvement in Total Symptom Score (TSS50) which improved to 80% at 38 weeks ofSNT-5505 is safe & well tolerated with no treatment related serious adverse events noted at this interim stage – viewed together with the excellent safety profile seen in the earlier monotherapy study this is emerging as another key differentiator to MF drugs on the market and in development treatment. TSS50 is a standard efficacy endpoint used as the primary endpoint in MF clinical trial.
Professor Claire Harrison, Professor of myeloproliferative neoplasms at Guy’s and St Thomas’ NHS Foundation Trust, commented:
“This interim data confirms the excellent safety profile of SNT-5505 and also suggests that the mechanism of SNT-5505 may exert a long-term effect on the disease, with both symptoms and spleen volume continuing to improve as we now see patients on drug for 9 months. This hasn’t been seen before with this class of drug and holds potential for real long-term benefits for MF patients. I look forward to seeing the data mature in the coming months to confirm these findings.
Ok that's great but let's place that in laypersons terms.
Better Results Than Other Drugs: So far, SNT-5505 seems to work better than other similar drugs being tested. Patients are seeing their symptoms improve and their spleen shrink, and these benefits keep getting better the longer they stay on the drug.
Excellent Safety: The drug has been very well tolerated. There have been no serious side effects linked to SNT-5505, which is a big plus cHow It Works: Unlike current treatments that mostly help with symptoms, SNT-5505 is designed to actually change the disease itself. It targets the root cause by reducing scar tissue in the bone marrow and blocking signals that make abnormal blood cells grow. This could help the bone marrow work more normally over time.
Improvements Over Time: Nearly half the patients had their symptoms cut in half after just 12 weeks, and this number went up to 80% after 38 weeks. Many also saw their spleen shrink a key sign the disease is being controlled compared to some other treatments.
This study had already been on standard treatment (ruxolitinib) for a long time but still had a lot of symptoms and large spleens. Seeing real improvements in this group is especially encouraging
The early results from the SNT-5505 trial show that the drug is very safe for patients, with no serious side effects so far. What’s even more promising is that patients are not just seeing quick improvements in their symptoms and spleen size, but these improvements are continuing and getting better the longer they stay on the drug-up to nine months so far. This ongoing improvement over time hasn’t been seen before with other drugs in this class.
If these results continue, it could mean that SNT-5505 offers real, lasting benefits for people with myelofibrosis, potentially changing the course of the disease for the better. Professor Harrison is optimistic but wants to see more data as the study continues to confirm these encouraging early findings
Reference : Syntara archive
Kpax
