Anti-inflammatory therapeutics developer Sen-Jam Pharmaceutical announced on Friday that, in collaboration with pharmaceutical manufacturer KVK Tech, it has completed the final development deliverables under their Development, Manufacturing, Distribution, and Licence Agreement.
KVK Tech has produced the required submission batches of SJP-002C and finalised the Chemistry, Manufacturing, and Controls (CMC) package, meeting FDA standards and positioning the programme for Phase 2b/3 clinical trials.
The product, a patented novel combination of indomethacin and ketotifen, aims to address inflammation while reducing the gastrointestinal risks typically related with NSAIDs.
Jackie Iversen, RPh, MS, co-founder and head of Clinical Development at Sen-Jam Pharmaceutical, said: "This milestone is about more than manufacturing readiness. 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."
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Sen-Jam Pharmaceutical and KVK Tech complete final development deliverables for SJP-002C