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Promising Results from Phase I Trial for New Anticoagulant Drug

Published: 7/8/2024
      
anticoagulant
Sirnaomics
Phase I study
STP122G
Factor XI
clinical trial
GalAhead
RNA therapeutics
blood clotting
safety profile

Key Takeaways

  • Interim results for Sirnaomics' anticoagulant STP122G show positive safety outcomes.
  • The Phase I study aims to determine the optimal dose for effectiveness and safety.
  • STP122G could provide a safer alternative for managing clot-related conditions.

Did You Know?

Did you know that Factor XI inhibitors like STP122G could offer safer alternatives for anticoagulation therapy with fewer bleeding risks?

Interim Findings Show Positive Progress

Sirnaomics Ltd. has reported encouraging interim results from their Phase I clinical study for their new anticoagulant drug, STP122G. The study involves healthy participants receiving various doses of the drug to evaluate its safety and effectiveness.

The second group of eight participants who received 50 mg of the drug showed no serious side effects or dose-limiting toxicities. This promising outcome has paved the way for testing higher doses in future cohorts.

Details of the Phase I Study

This first-phase study aims to test the safety, tolerability, and effectiveness of STP122G, which is being administered under controlled conditions. The study is structured to ensure all findings are rigorously evaluated before moving to subsequent phases.

Sirnaomics plans to conduct the study across five different dose levels: 25 mg, 50 mg, 100 mg, 200 mg, and 400 mg. The ultimate goal is to identify the optimal dose that offers the highest efficacy with the least risk.

What is STP122G?

STP122G is an innovative drug designed to inhibit Factor XI, an enzyme involved in blood clotting. By targeting Factor XI, it aims to offer a new approach to preventing and treating clot-related conditions like deep vein thrombosis and pulmonary embolism.

This drug utilizes Sirnaomics' advanced GalAhead™ mxRNA technology, which allows for precise targeting of liver cells to reduce the production of Factor XI. This targeted approach may offer long-lasting benefits with fewer side effects compared to current anticoagulants.

Future Steps in the Study

Given the positive safety profile seen in the first two cohorts, Sirnaomics will proceed to higher doses. The total planned participants for this study is 40, with each group receiving escalating doses to better understand the drug's effect.

The company aims to select the most effective dosage for further clinical trials, potentially leading to broader use in treating various conditions associated with abnormal blood clotting.

The Broader Impact of STP122G

STP122G has the potential to address multiple health issues. Its innovative approach could be beneficial for patients who need anticoagulation therapy but face bleeding risks with current medications.

The successful development of STP122G could therefore offer a significant advancement in how clot-related conditions are managed, providing a safer and more effective treatment option for many patients.

Conclusion

The interim results from Sirnaomics' Phase I study are promising and suggest that STP122G could be a valuable addition to the range of anticoagulation therapies. As the study progresses, more data will help refine the drug’s dosage and efficacy, moving it one step closer to availability for patient use.

Sirnaomics continues to innovate in the field of RNA therapeutics, aiming to bring new solutions to unmet medical needs. STP122G is a testament to their commitment to advancing medical science and improving patient outcomes.

References

  1. Sirnaomics Announces Interim Results for RNAi Therapeutic
    https://www.sirnaomics.com/interim-results-RNAi-therapeutic
  2. Clinical Trial Identifier: NCT05844293
    https://clinicaltrials.gov/ct2/show/NCT05844293
  3. Understanding Factor XI and Anticoagulation
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7661088/