M230 - Excerpts: “I think many of the analysts thought ‘oh you’re just going to replace IVIG with a recombinant product.’ But, we’re going to take one of the mechanisms of action of IVIG and make a much more potent and effective molecule,” said Manning. He added that the companies plan to test the compound in patients who don’t respond to IVIG.
Because other immunosuppressive therapies for autoimmunity increase risk of infection, the Momenta team administered the trimer to rodents and monkeys housed under non-sterile conditions. After three months of dosing, the company found no infections in any of the animals, similar to vehicle-treated animals. “We have gone to the maximum feasible dose possible,” said Manning. “We were up in the hundreds of milligrams per kilo. I can tell you over the three months we had completely saturated every Fc? receptor for twenty four hours every day and to date, the toxicology profile is very, very benign.”