-Top-Line Results Show Efficacy at 200 mg Q1W Dose-
-Blisibimod Ph. 3 Should Differentiate From Benlysta-
Report is Available for Download at: www.lifesciadvisors.com/clients/anthera
This note discusses in detail Anthera Pharmaceuticals’ (NASDAQ: ANTH) Phase 2b PEARL-SC study results for blisibimod. While investors reacted swiftly to the study not meeting the primary endpoint due to no efficacy in the low-dose arms (endpoint pooled all three doses versus PBO), the 200 mg Q1W blisibimod dose showed a clear efficacy signal. The 200 mg dose is expected to advance into Phase 3 and compares favorably to Benlysta’s efficacy.
The Market Potential of Blisibimod is Not Reflected in the Anthera’s Valuation. As of Friday’s close, Anthera is trading at $0.74, which equates to a $30MM market cap and a $11MM enterprise value, using the 41.1MM fully diluted share count. Obviously, the low company valuation reflects the knee-jerk reaction of investors to the PEARL-SC data and does not reflect much value for the capacity of blisibimod to capture a portion of the ~$3-4B lupus market potential. Even if blisibimod’s is developed for the severe lupus patients only, this population accounts for ~50% of the market, or a $1.5-2B. Hence, very little value is being ascribed to blisibimod despite the positive signal observed in the high dose arm.
200 mg Q1W Blisibimod Dose Group Demonstrates Favorable Response Trends in Anticipated Phase 3 Population. In the Phase 2b PEARL-SC study, 547 patients were randomized to one of three subcutaneous doses (200 mg Q1M, 100 mg Q1W and 200 mg Q1W) or matching placebo (PBO). The primary endpoint was SRI-5 (Systemic Lupus Responder Index) of combined 270 active patients versus 270 PBO patients at 24 weeks. While the two low dose groups didn’t have an effect on SRI-5, it is important to consider that Benlysta also did not showed a treatment effect at 24 weeks in the BLISS-76 study, yet was still approved based upon 52 week results. With that said, the 200 mg Q1W blisibimod dose demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44, including a statistically significant improvement at week 20 versus placebo (p=0.02). This is a very important finding and establishes this dose for Phase 3 trials.