BioWorld International Correspondent
Swedish drug development firm Biovitrum AB is looking to move its lead compound, an appetite-suppressing obesity treatment called BVT.933, into Phase IIb trials following positive Phase IIa results.
A Phase IIb study is slated for later this year, but ongoing partnering discussions could alter the timetable, Johan Koerdel, Biovitrum’s head of research and development, told BioWorld International.
In the Phase IIa, 154 obese but otherwise healthy volunteers received either placebo or BVT.933 in one of two dosages over a four-week period.
Stockholm-based Biovitrum said subjects in both dose groups achieved “a statistically significant and clinically relevant weight reduction compared to placebo.” Biovitrum would not disclose further details due to the ongoing partnering discussions, but Koerdel was pleased with results.
“Many experts in the field would not have expected a statistically significant weight reduction over four weeks of dosing,” he said. Moreover, the study was conducted without dietary restrictions, instructions regarding exercise or other lifestyle parameters.
BVT.933 is an agonist of the 5-HT2C receptor, a member of the serotonin receptor family. It is the first compound to specifically target the HT2C receptor, Kordel said. “We’re seeing effects that we would expect from the pharmacological action of a 5-HT2C receptor agonist,” he said.
The anti-obesity market is currently “a little bit north of $1 billion” but underdeveloped, Koerdel said. The two main marketed therapies are Xenical (orlistat), sold by F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Meridia (sibutramine hydrochloride monohydrate), marketed by Abbott Laboratories Inc., of Abbott Park, Ill.
Biovitrum was spun out from Pharmacia Corp., of Peapack, N.J., last year in an SEK1.5 billion (US$144.3 million) deal supported by a group of investors led by Nordic Capital and MPM Capital (see BioWorld International, Aug 8, 2001). It gained two new backers later in the year, when Alta Partners and HBM BioVentures acquired 16 percent of its equity from Pharmacia. The latter company now holds a 19 percent stake.