Fixed-Dose Combination (FDC)
IT-102 is a bilayer fixed-dose combination (FDC) formulation of celecoxib, a diaryl substituted pyrazole, and lisinopril, a long-acting angiotensin converting enzyme inhibitor, indicated in patients for whom treatment with both celcoxib and lisinopril is appropriate. The indiciations for the combination product are based on the indications for the individual components that have been approved by the Food and Drug Administration (FDA).
Indications approved by the FDA for celecoxib that are of interest to IT-102 :
- Relief of the signs and symptoms of osteoarthritis
- Relief of the signs and symptoms of rheumatoid arthritis in adults
- Management of acute pain in adults
Indication approved by the FDA for lisinopirl that is of interest to IT-102 :
- Treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
Based on the above information and the coexistence of arthritis pain and hypertension in populations, IT-102 is being developed for the combined treatment of arthritis and hypertension. The preference for and improved compliance with a single tablet makes the proposed FDC formulation a very useful drug for treatment of 2 common conditions with increasing frequency in the aging population. Additionally, combination of lisinopril with celecoxib may reduce the incidence of cardiovascular adverse events and edema associated with celecoxib treatment.
As celecoxib also has proven activity against FAP, the merger of Marina Biotech with IthenaPharma brings two clinical products with proven activity against FAP to kick start and de-risk the CEQ508 program. IT-102 will be further developed as an enhancer of CEQ508 in FAP.