Sen-Jam Pharmaceutical and KVK Tech Reach Key Milestone in CMC
Significant Progress in CMC Deliverables for SJP-002C
The recent achievement by Sen-Jam Pharmaceutical and KVK Tech marks an important milestone for SJP-002C, paving the way for its progression in late-stage clinical trials. The partners have successfully finalized the Chemistry, Manufacturing, and Controls (CMC) package, solidifying the regulatory groundwork necessary for the upcoming Phase 2b/3 clinical studies.
Combination Therapy Potentials
SJP-002C is a groundbreaking formulation that combines two powerful components: indomethacin, known for its anti-inflammatory properties, and ketotifen, which acts as an H1-antihistamine and mast cell stabilizer. This carefully designed combination not only targets inflammation but also alleviates some of the gastrointestinal risks commonly associated with non-steroidal anti-inflammatory drugs (NSAIDs).
Leadership Perspectives
Jackie Iversen, Co-Founder and Head of Clinical Development at Sen-Jam Pharmaceutical, expressed enthusiasm about the milestone. "This milestone signifies more than just preparing for manufacturing. It aligns with our mission to elevate a new class of immunoregulators aimed at re-establishing balance within the immune system. Our efforts to combat both inflammaging and immunosenescence position SJP-002C not only as an immediate therapeutic option but also as a part of a broader longevity strategy," said Iversen.
Partnership with KVK Tech
KVK Tech has played a crucial role in this progress. Kiran Vepuri, Executive Vice President of Business Development at KVK Tech, conveyed pride in supporting Sen-Jam's initiatives. "Completing the submission batches and CMC package for SJP-002C demonstrates our commitment to quality and timeliness. As both a strategic collaborator and equity holder in Sen-Jam, we are passionate about advancing therapies that serve vital health needs. Our collaboration reinforces our shared goal of facilitating the advancement of necessary treatments," stated Vepuri.
Benefits of the CMC Milestone
Several advantages arise from this recent accomplishment, further reinforcing the program's future:
- Regulatory Readiness: The delivery of three validated submission batches along with a complete CMC package provides a strong foundation for clinical and regulatory requirements.
- De-Risking the Program: The completion of manufacturing and stability work enhances the potential for clinical development to proceed without interruption.
- Scientific & Strategic Validation: Recent commentary from industry experts highlights the significance of immunoregulators in addressing challenges associated with inflammaging, positioning Sen-Jam as a leader in this evolving sector.
- Strong Intellectual Property: With global patent protection, including a patent on the manufacturing process for SJP-002C, Sen-Jam secures robust commercialization opportunities.
- Next Steps – Phase 2b/3 Trials: With CMC deliverables completed, SJP-002C is now well-prepared for the next phase of clinical testing, representing a strategic advancement in its development.
About Sen-Jam Pharmaceutical
Sen-Jam Pharmaceutical focuses on innovating anti-inflammatory treatments that emphasize accessibility and rapid deployment in healthcare settings globally. Their commitment to addressing unmet needs continues to drive advancements in therapeutic strategies.
About KVK Tech
KVK Tech is a prominent pharmaceutical manufacturer based in the U.S., registered with the FDA and dedicated to delivering high-quality, affordable medicines. Their expertise in formulation and CMC positions them as a strategic partner to Sen-Jam in enhancing the availability of innovative therapies like SJP-002C.
Frequently Asked Questions
What is SJP-002C?
SJP-002C is an innovative combination of indomethacin and ketotifen aimed at managing inflammation and minimizing gastrointestinal risks commonly faced with NSAIDs.
Who is involved in the development of SJP-002C?
Sen-Jam Pharmaceutical and KVK Tech are the primary partners advancing SJP-002C through its late-stage clinical development.
What milestones have been achieved for SJP-002C?
Completion of submission batches and the full CMC package, both vital for regulatory compliance and readiness for clinical trials, mark the key milestones achieved.
How does SJP-002C fit into the broader therapeutic landscape?
SJP-002C is part of Sen-Jam's larger mission to develop immunoregulators that mitigate issues related to inflammaging and support longevity strategies.
What role does KVK Tech play in this partnership?
KVK Tech serves as Sen-Jam's exclusive U.S. manufacturing and distribution partner, contributing to the production and readiness of SJP-002C for clinical trials.
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