Sen-Jam Pharmaceuticals and KVK Tech Achieve Key Milestone for SJP-002C, Ushering into Late-Stage Clinical Trials
In a significant stride towards advancing innovative therapeutics, Sen-Jam Pharmaceutical has announced the successful completion of final development deliverables for SJP-002C, in collaboration with KVK Tech. This milestone is crucial as it lays a solid foundation for the upcoming late-stage clinical trials necessary for SJP-002C's regulatory approval. The completed Chemistry, Manufacturing, and Controls (CMC) package, which meets the stringent FDA standards, positions the drug optimally for its Phase 2b/3 clinical studies.
SJP-002C represents a groundbreaking formulation combining indomethacin, a powerful non-steroidal anti-inflammatory drug, with ketotifen, an h1-antihistamine known for its mast cell stabilization properties. The synthesis of these two agents addresses inflammation while minimizing the gastrointestinal side effects frequently associated with NSAIDs, thus promoting patient safety without compromising efficacy.
Jackie Iversen, RPh, MS, Co-Founder and Head of Clinical Development at Sen-Jam Pharmaceutical, emphasized the importance of this achievement, stating that it goes beyond merely being ready for manufacturing. This milestone reflects a broader mission: to develop a new class of immunoregulators that rebalance the immune system, specifically targeting the concepts of inflammaging and immunosenescence. Sen-Jam views SJP-002C as not just a short-term therapeutic solution but as part of a more expansive strategy focused on promoting longevity and overall health.
Kiran Vepuri, Executive Vice President of Business Development at KVK Tech, echoed this sentiment. He expressed pride in supporting Sen-Jam by timely completing manufacturing and CMC tasks, ensuring that Sen-Jam is prepared to proceed to clinical studies without any delays. As both a strategic partner and equity holder in Sen-Jam, KVK Tech is committed to advancing vital therapies together.
The completion of the CMC package and submission batches is pivotal for several reasons:
Sen-Jam Pharmaceutical is at the forefront of a new generation of anti-inflammatory therapies, aiming for a balance between rapid market readiness and global health impacts. Their bold vision is backed by significant capital-raising efforts aimed at accelerating their research and development initiatives.
KVK Tech serves as Sen-Jam's dedicated U.S. manufacturing and distribution partner. Recognized for its commitment to high-quality and affordable medical solutions and equipped with advanced facilities, KVK Tech is strategically and financially committed to Sen-Jam’s mission, ensuring both parties are well-equipped for the future of immunotherapeutics.
In conclusion, the completion of CMC deliverables by Sen-Jam Pharmaceutical and KVK Tech marks a significant milestone in the development of SJP-002C, reinforcing both companies' commitment to innovative health solutions aimed at improving the quality of life through advanced therapeutic options.
SJP-002C represents a groundbreaking formulation combining indomethacin, a powerful non-steroidal anti-inflammatory drug, with ketotifen, an h1-antihistamine known for its mast cell stabilization properties. The synthesis of these two agents addresses inflammation while minimizing the gastrointestinal side effects frequently associated with NSAIDs, thus promoting patient safety without compromising efficacy.
Jackie Iversen, RPh, MS, Co-Founder and Head of Clinical Development at Sen-Jam Pharmaceutical, emphasized the importance of this achievement, stating that it goes beyond merely being ready for manufacturing. This milestone reflects a broader mission: to develop a new class of immunoregulators that rebalance the immune system, specifically targeting the concepts of inflammaging and immunosenescence. Sen-Jam views SJP-002C as not just a short-term therapeutic solution but as part of a more expansive strategy focused on promoting longevity and overall health.
Kiran Vepuri, Executive Vice President of Business Development at KVK Tech, echoed this sentiment. He expressed pride in supporting Sen-Jam by timely completing manufacturing and CMC tasks, ensuring that Sen-Jam is prepared to proceed to clinical studies without any delays. As both a strategic partner and equity holder in Sen-Jam, KVK Tech is committed to advancing vital therapies together.
Importance of the Milestone
The completion of the CMC package and submission batches is pivotal for several reasons:
- - Regulatory Readiness: With a total of three validated submission batches and a comprehensive CMC package, the project is fully equipped to meet late-stage clinical and regulatory demands.
- - De-Risked Program: The successful completion of stability and manufacturing processes allows clinical development to progress on schedule.
- - Scientific Validation: Insights from Oppenheimer Research have highlighted the significance of immunoregulators in treating inflammaging. Sen-Jam is positioned uniquely in this burgeoning longevity market.
- - Robust Intellectual Property: The pharmaceutical company's patent estate, including a process patent for SJP-002C, offers strong protection and commercialization advantages.
- - Next Steps — Phase 2b/3 Trials: With the successful CMC deliverables, SJP-002C is now ready to commence its next stage of clinical evaluation.
About Sen-Jam Pharmaceutical
Sen-Jam Pharmaceutical is at the forefront of a new generation of anti-inflammatory therapies, aiming for a balance between rapid market readiness and global health impacts. Their bold vision is backed by significant capital-raising efforts aimed at accelerating their research and development initiatives.
About KVK Tech
KVK Tech serves as Sen-Jam's dedicated U.S. manufacturing and distribution partner. Recognized for its commitment to high-quality and affordable medical solutions and equipped with advanced facilities, KVK Tech is strategically and financially committed to Sen-Jam’s mission, ensuring both parties are well-equipped for the future of immunotherapeutics.
In conclusion, the completion of CMC deliverables by Sen-Jam Pharmaceutical and KVK Tech marks a significant milestone in the development of SJP-002C, reinforcing both companies' commitment to innovative health solutions aimed at improving the quality of life through advanced therapeutic options.
Topics Health）
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