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."
LEO Pharma advances delgocitinib cream into phase 3 trial for lichen sclerosus
HistoIndex partners Houston Research Institute
Formosa Pharmaceuticals licenses APP13007 ophthalmic therapy to Samil for South Korea
Bambusa Therapeutics reports first patient dosed in proof-of-concept COPD trial
Elanco Animal Health's Befrena (tirnovetmab) receives USDA approval for canine dermatitis
Sanofi and Regeneron's Dupixent gains Japan approval for paediatric asthma patients aged 6 to 11
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
Alvotech launches first-in-market golimumab biosimilar in Europe
Physiomics secures follow-on UK contract for Phase 2 study support
RedHill Biopharma reports positive opaganib data in venetoclax-resistant CLL
InduPro secures strategic investment and collaboration with Sanofi to advance autoimmune therapy
Innovent Biologics reports first participant dosed in Phase 1 trial of IBI3011