Princeton, NJ-based Soligenix ($SGNX) called a sudden halt to its late-stage study of orBec--an oral formulation of beclomethasone dipropionate for acute gastrointestinal Graft-versus-Host disease--after its monitoring board called the game off due to a notable absence of efficacy. And now the biotech plans to study its options on cost containment, including possibly axing the disappointing program, as it turns its focus to vaccines as well as other possible uses of oral BDP.
The biotech's CEO, Christopher J. Schaber, declared that he was stumped over why the confirmatory trial had ended in failure. But he suggested that "changes in the overall treatment practices of the allogeneic stem cell transplantation patient population that may have had an impact on the treatment effect of orBec since the previous Phase III study was concluded in 2004." Soligenix's stock is listed on the Over The Counter Bulletin Board and closed yesterday at 26 cents. By mid-morning the news had obliterated much of its remaining value, sliding 85% to a mere three cents.
A little more than a month ago Italy's Sigma-Tau Pharmaceuticals bet $5 million upfront for a European licensing deal on orBec, expanding their North American pact. Another $11 million was promised in potential milestones, with $2 million tied to the successful conclusion of the Phase III study. Sigma-Tau has been a steady partner on this program. The company inked a $30 million licensing deal for orBec's North American rights in 2009, when Soligenix was operating under its old name, Dor BioPharma.
The sudden halt of this Phase III, though, couldn't have come as a complete surprise. The treatment had failed its first Phase III, where the primary endpoint was geared to median time-to-treatment failure through Day 50. But it scored well on the secondary endpoints, which had kept their hopes for the drug alive.
- here's the Soligenix release