• Product Pipeline
  • Immuno-Inflammatory
  • CRx-102
  • CRx-139
  • Pain
  • CRx-170
  • Topical Dermatology
  • CRx-191
  • CRx-197
  • Metabolic
  • CRx-401
  • Clinical Trials
  • Research Programs
Products > Immuno-Inflammatory Program > CRx-139

CRx-139

A dissociated steroid designed to enhance the immuno-modulatory activity of a low-dose glucocorticoid steroid without a comparable increase in steroid-related side effects.

  • Description: Synergistic combination containing low doses of the glucocorticoid steroid prednisolone and the antidepressant paroxetine.
  • Data: Positive activity in a human biomarker study against validated inflammatory biomarkers. Activity on certain RA endpoints in a phase 2a clinical trial.
  • Formulation: Developing co-formulated, modified-release capsule.
  • Commercial Opportunity: Novel synergistic combination for the treatment of immuno-inflammatory diseases.
About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic disease, mainly characterized by inflammation of the lining, or synovium, of the joints. According to the Arthritis Foundation, rheumatoid arthritis affects one percent of the United States population, or 2.1 million Americans. Rheumatoid arthritis can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. Because it is a chronic disease, rheumatoid arthritis continues indefinitely, and frequent flares in disease activity can occur. Rheumatoid arthritis is also a systemic disease, which means it can affect other organs in the body. Studies have shown that early aggressive treatment of rheumatoid arthritis can limit joint damage, which in turn limits loss of movement, decreased ability to work, higher medical costs and potential surgery.

Status: Currently on hold with no further development investment.

Clinical Results:

Phase 2a Rheumatoid Arthritis

We investigated CRx-139 in a phase 2a clinical trial studying CRx-139 versus 3mg prednisolone alone, in patients with rheumatoid arthritis (RA) (Full News Release). This trial served two important purposes. One purpose was to determine the effect of 3mg of prednisolone alone (a very low dose) in RA and to contrast this effect with the activity previously reported with CRx-102, a synergistic combination of very low dose prednisolone and dipyridamole.

  • CRx-139 did not show statistical significance vs. 3mg prednisolone alone as measured by ACR20 at day 70, the primary endpoint of the trial.
  • CRx-139 did show statistical significance on multiple other endpoints, including ACR20 and ACR50 at earlier time points requiring further analysis.
  • The results with 3mg prednisolone confirm that the anti-inflammatory benefits previously observed in three phase 2a clinical trials with CRx-102 are due to the synergistic activity of CRx-102's components, as opposed to an effect derived from the prednisolone component alone.
  • In this trial, CRx-139 was generally well tolerated, and there were no drug-related serious adverse events reported for subjects treated with CRx-139. The most common adverse events observed with CRx-139 that occurred with a frequency of greater than 5% were headache and nausea, known side effects of paroxetine, one of the two components of CRx-139.

ACR20 and ACR50 are standard measures developed by the American College of Rheumatology to rate RA disease improvement. Patients are classified as ACR20 responders if they demonstrate at least a 20% improvement from baseline in tender and swollen joint count and at least 3 of 5 other symptom-related criteria. Patients are classified as ACR50 responders if they demonstrate at least a 50% improvement from baseline using the same criteria.