After failing to meet the primary endpoint in a Phase II study of TP10 in adult patients undergoing high-risk cardiac surgery, Avant Immunotherapeutics Inc. said it would not devote further time or resources to the program.
And although that wipes out not only the adult Phase II trial but also two Phase IIb trials in infants undergoing cardiac surgery, Avant CEO Una Ryan said the failure does little to alter Avant’s path.
“There is really no change for us in direction,” she told BioWorld Today. “The most advanced programs [for Avant] were the vaccines and we’ll be moving full-steam ahead on those.”
In the trial, 564 patients were randomized to receive one of four doses 1, 3, 5 or 10 mg/kg of TP10 or placebo as a 30-minute intravenous infusion. The patients were followed for 28 days post-surgery with the primary endpoint being the comparison of the number of TP10 vs. placebo patients who experienced death, myocardial infarction, required prolonged intubation or prolonged intra-arterial balloon-pump therapy. The trial showed no “clinically important” differences between placebo and any of the four dose groups.
Wall Street was expecting more. Avant’s stock (NASDAQ:AVAN) fell $1.94 Wednesday, or 64.7 percent, to close at $1.06.
Although Avant saw “glimmers of hope” in the data, Avant’s focus no longer includes cardiac surgery but is now “serious travelers’ diarrhea, chronic viral disease and cholesterol,” Ryan said.
The company has its CholeraGarde cholera vaccine that is expected to move into Phase III trials shortly, as well as an oral-dose rotavirus vaccine partnered with GlaxoSmithKline plc, of London, which should do the same. It also has Ty800 typhoid vaccine that is scheduled, in short order, to move into Phase II. Plus, Avant has CETi-1, an immunotherapeutic for cholesterol management, in clinical development, and a vaccine to treat anthrax that Avant has licensed to DynPort Vaccine Co. LLC.
Overall, Needham, Mass.-based Avant has five travelers’ vaccines that are orally formulated. Ryan believes that technology may have applications in the opposite direction as well those staying within the country’s boundaries.
“Something new that we haven’t licensed yet is taking our user-friendly, oral, single-dose technology and applying it to biowarfare vaccines,” she said, adding that the company is in discussions with the government.
Ryan said the manufacturing process is similar for all its travelers’ vaccines the products are live attenuated bacteria. TP10, a complement inhibitor, is a “large human protein manufactured in mammalian cells,” Ryan said, and thus was a “bit of an odd man out” in Avant’s drug arsenal.
Ryan said Avant would continue to put together data on TP10, including information from the infant Phase IIb trials, and perhaps pen academic papers. But Avant will sit down, evaluate the program and then make a decision about what to do next with TP10. What that means is unclear understandable given the short period Avant has had since the trial was discovered to have gone south but it does mean no additional Avant funds for TP10.
“There are other indications [for the drug] and there is a lot of intellectual property,” Ryan said. “We haven’t had time to think through all the options but we will find the best value we can.” She added, “The best use of our resources is in the vaccine area, where everything is going well.”
Ryan acknowledged the TP10 results were a setback, but said there’s more to Avant that TP10.
“We’re very disappointed but I want to remind you and the Street that we didn’t have all our eggs in one basket,” she said. “We have great risk diversification.”