Synavive™ (CRx-102)

A dissociated steroid with a novel mechanism to provide the immuno-inflammatory benefits of glucocorticoid steroids without associated steroid side effects.

• Description: Synergistic combination of prednisolone, a glucocorticoid steroid, and dipyridamole, a cardiovascular drug. We believe Synavive works through a novel mechanism that selectively amplifies the glucocorticoid steroid's desirable activities without replicating associated side effects.
• Data: Positive phase 2a clinical results in hand osteoarthritis (OA), rheumatoid arthritis (RA) and an inflammatory biomarker study. Demonstrated treatment benefit over placebo across a variety of efficacy measures in Phase 2 knee OA study.
• Formulation: Developing a modified-release, once-daily capsule potentially providing greater synergy through co-exposure and an improved tolerability profile.
• Commercial opportunity: NSAID/COXIB replacement in OA. Replacement of, or add-on to, some NSAIDS, steroids and DMARDs in RA.

OA represents a market of 33 million patients in the U.S., and RA has another 2 million patients in the U.S.

Status: Completed Phase 2 study in Knee OA.

Phase 2a Rheumatoid Arthritis

We studied Synavive in a multi-center randomized, blinded, placebo-controlled phase 2a clinical trial of 59 patients with rheumatoid arthritis (Full News Release). The clinical trial compared CRx-102 plus a disea se-modifying, anti-rheumatic drug (DMARD) to placebo plus DMARD in subjects with rheumatoid arthritis. Synavive demonstrated statistically significant ACR20 response at day 42 compared to placebo.

Phase 2a Hand Osteoarthritis

We studied Synavive in a randomized, blinded, placebo controlled phase 2a clinical trial in 83 patients with moderate to severe osteoarthritis of the hand in Norway (Full News Release). The study met its primary endpoint of improvement in joint pain using the AUSCAN index. The AUSCAN Osteoarthritis Index is a composite patient-reported outcome tool developed specifically for hand osteoarthritis, similar to the WOMAC index which is used for knee and joint osteoarthritis. Synavive demonstrated statistically significant improvement in pain compared to placebo.

Phase 2b Knee OA

We studied Synavive in a randomized, double-blind placebo controlled phase 2b clinical trial in 279 patients with symptomatic knee OA. Synavive provided treatment benefits compared to placebo across a range of efficacy measures, including pain, stiffness and physical function.

CRx-102 was generally well tolerated, and there were no serious adverse events reported from patients taking CRx-102.