Human Genome Sciences (NASDAQ: HGSI) has released an updated look at its experimental lupus drug, noting that the closely watched Benlysta failed to achieve a secondary endpoint on a statistically significant response after 76 weeks of therapy. The primary endpoint was a significant response after a year of therapy, though, a key objective that has already been hit in the pivotal Phase III.
A total of 38.5 percent of all lupus patients responded to the high dose of Benlysta after 76 weeks, compared with the 32.4 percent of responders on a placebo. That wasn't a wide enough margin to hit the secondary endpoint. But it also wasn't so far off the mark that the updated data would likely derail efforts to gain FDA approval.
TheStreet's Adam Feuerstein, though, noted that if the drug effect wanes after a year of therapy, doctors could be persuaded to shorten the treatment stage, a response that could take a bite out of Benlysta's expected blockbuster revenue. HGS and its partner GlaxoSmithKline appear eager to file for an approval of Benlysta later in 2010, with positive data from two late-stage trials to rely on.
"A positive overall picture has emerged from our pivotal Phase III studies of Benlysta, including its achievement of statistical significance on the primary efficacy endpoint at Week 52 with a favorable safety profile in both BLISS-52 and BLISS-76," said HGS CEO Tom Watkins. "We view the results of these studies as strongly supportive of our view that Benlysta has the potential to become the first new approved drug in more than 50 years for people living with systemic lupus."
- here's the HGS press release
- and here's the analysis from TheStreet