Completion of submission batches and NDA-ready CMC package strengthens regulatory foundation for upcoming Phase 2b/3 trials and underscores Sen-Jam's leadership in immunoregulation and inflammaging.

Sen-Jam Pharmaceutical, in partnership with KVK Tech, announced the successful completion of the final development deliverables under their Development, Manufacturing, Distribution, and Licence Agreement. KVK Tech has manufactured the required submission batches of SJP-002C and finalized the Chemistry, Manufacturing, and Controls (CMC) package, meeting FDA standards and positioning the program for Phase 2b/3 clinical trials.

SJP-002C is a patented novel combination of indomethacin, a potent non-steroidal anti-inflammatory drug, and ketotifen, an H1-antihistamine and mast cell stabilizer. Together, they address inflammation while reducing the gastrointestinal risks typically associated with NSAIDs.

"This milestone is about more than manufacturing readiness," said Jackie Iversen, RPh, MS, Co-Founder and Head of Clinical Development at Sen-Jam Pharmaceutical. "It reflects our broader mission to advance a new class of immunoregulators that restore balance to the immune system. By targeting inflammaging and immunosenescence, we are building a pipeline with potential far beyond acute conditions—positioning SJP-002C as both a near-term therapeutic and part of a longer-term longevity strategy."

"We are proud to support Sen-Jam by completing the submission batches and CMC package for SJP-002C," said Kiran Vepuri, Executive Vice President of Business Development at KVK Tech. "Our focus has been on quality and readiness so that Sen-Jam can proceed into late-stage clinical studies without delay. As both a strategic partner and equity holder in Sen-Jam, we are deeply committed to advancing much-needed therapies together."

Importance of the Milestone

• Regulatory Readiness: Completion of three validated submission batches and a full CMC package suitable for late-stage clinical and regulatory requirements.
  
  
• De-Risking the Program: Manufacturing and stability work complete, allowing clinical development to advance on schedule.
  
  
• Scientific & Strategic Validation: Recent commentary from Oppenheimer Research noted the role of immunoregulators in addressing inflammaging, highlighting Sen-Jam's pipeline as a differentiated opportunity in the longevity sector.
  
  
• Strong Intellectual Property: Sen-Jam's global patent estate, now including a manufacturing process patent for SJP-002C, provides robust protection and commercialization leverage.
  
  
• Next Step – Phase 2b/3 Trials: With CMC deliverables complete, SJP-002C is now positioned to begin the next phase of clinical testing.