Pipeline Case Study Summary
Shifting Focus to Pipeline Programs
Over past few years, Arena Pharmaceuticals has restructured and rebuilt their organization. Long known as a weight loss company, Arena has shed its former image to focus on their proprietary clinical stage pipeline. In addition to ralinepag, Arena Pharmaceutical’s proprietary pipeline portfolio includes two other drugs: Etrasimod (APD334) and APD371. Etrasimod (APD334), a next generation S1P receptor modulator, is currently in multiple Phase 2 trials for autoimmune diseases. Results from Phase 2 trial in ulcerative colitis is expected by the end of the year. Unlike first generation receptor modulators, APD334 is selective in which receptors are targeted. In earlier studies, ADP334 has demonstrated significant lymphocyte reduction and a positive safety profile. …show more content…
Compared to the placebo group, which did not see much change in PVR, the experimental group saw a PVR improvement of 163.9 dyn.s.cm-5. The difference between the two groups was statistically significant with p=0.02. Secondary endpoints included actual percentage change of PVR from baseline, and absolute change in 6-minute walk distance (6MWD). Patients treated with ralinepag experienced a 20.1% improvement compared to baseline, and a 29.7% improvement compared to placebo. Compared to baseline, patients treated with ralinepag improved their walk distance by 36.2 meters, while patients treated with placebo arm improved by 29.4 meters. The difference between these two arms is not statistically significant. For reasons unknown, there was a high degree of similarity in 6MWD between the two arms, which differs from historic controls. Physicians generally consider a range of 15-20% decrease in PVR, and a 30-meter walking distance as clinically important for patients. Ralinepag was able to reach primary and secondary endpoints with the release of impressive top-line
Over past few years, Arena Pharmaceuticals has restructured and rebuilt their organization. Long known as a weight loss company, Arena has shed its former image to focus on their proprietary clinical stage pipeline. In addition to ralinepag, Arena Pharmaceutical’s proprietary pipeline portfolio includes two other drugs: Etrasimod (APD334) and APD371. Etrasimod (APD334), a next generation S1P receptor modulator, is currently in multiple Phase 2 trials for autoimmune diseases. Results from Phase 2 trial in ulcerative colitis is expected by the end of the year. Unlike first generation receptor modulators, APD334 is selective in which receptors are targeted. In earlier studies, ADP334 has demonstrated significant lymphocyte reduction and a positive safety profile. …show more content…
Compared to the placebo group, which did not see much change in PVR, the experimental group saw a PVR improvement of 163.9 dyn.s.cm-5. The difference between the two groups was statistically significant with p=0.02. Secondary endpoints included actual percentage change of PVR from baseline, and absolute change in 6-minute walk distance (6MWD). Patients treated with ralinepag experienced a 20.1% improvement compared to baseline, and a 29.7% improvement compared to placebo. Compared to baseline, patients treated with ralinepag improved their walk distance by 36.2 meters, while patients treated with placebo arm improved by 29.4 meters. The difference between these two arms is not statistically significant. For reasons unknown, there was a high degree of similarity in 6MWD between the two arms, which differs from historic controls. Physicians generally consider a range of 15-20% decrease in PVR, and a 30-meter walking distance as clinically important for patients. Ralinepag was able to reach primary and secondary endpoints with the release of impressive top-line