-New Positive PEARL-SC Secondary Results Reported-
-Phase 3 Development Strategy Validated by FDA-
Report is Available for Download at: www.lifesciadvisors.com/clients/anthera
Anthera Pharmaceuticals announced earnings last Thursday and also recently announced that it has officially completed End of Phase 2 meetings with the FDA. Included with earnings, was additional positive PEARL-SC data. Also, per the completion of the End of Phase 2, the Company has announced that they plan to advance the blisibimod program into Phase 3 in what we view as the optimal patient population (SS>10, SRI-8).
New Secondary PEARL-SC Results Continue to Show Positive Blisibimod Treatment Effects. During earnings, Anthera provided addition clinical results from the PEARL-SC study, which indicated that there were strong trends towards increased time to first lupus flare (1.8 fold) and to first severe lupus flare (1.6 fold) when compared to placebo. Also, 200 mg blisibimod patients demonstrated an improvement in proteinuria over 24 weeks. This results in the near normalization of the protein:creatinine ratio compared to baseline in patients taking blisibimod versus the placebo group, which had no improvement. Anti-dsDNA antibody levels significant decreased in the pooled blisibimod compared to the pooled placebo group (-23.2 IU vs. -8.8 IU, Po<0.001) at week 24.
85% of the Positive SRI-8 Treatment Effect in PEARL-SC was Due to Clinical Improvement. Previously, we discussed the PEARL-SC results, which showed that in a predefined population of lupus patients with clinically active disease (SELENA-SLEDAI (SS) >10) that were on steroids, blisibimod had a statistically significant SRI-8 treatment effect in the 200 mg weekly cohort at week 8 (22.6% vs. 6.4% placebo response, p=0.023), at week 16 (35.4% vs. 17.0%, p0.04), and at the 24 week endpoint (41.7% vs. 10.4%, p<0.001). Worth noting, 85% of the SRI-8 treatment effect observed was due to clinical improvement as opposed to serology measures. We provide a more detailed discussion of these results later in our note.