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running an experiment related to an antibody for Alzheimer’s. She wanted to find a way to reduce the side effects of the antibody, so she decided to put it on a filamentous bacteriophage called M13—a virus that targets bacteria—and give it to mice.
The results didn’t make any sense. Mice that got the virus with no drug attached to it were seeing a therapeutic effect. So she started putting the virus into test tubes with aggregates like beta amyloid and plaque-forming proteins associated with other neurodegenerative diseases. The phage was breaking them up too. The key was to figure out why.
The younger Solomon then teamed with Hillerstrom and decided to take on the problem. They licensed the IP surrounding the phage from Tel Aviv University, and formed Neurophage around it. They’ve since been able to secure three different venture rounds, raising a total of $35 million from Shire, Merieux Developpement, and private angel investors.
Using that cash, Neurophage’s scientists then studied the phage to figure out which parts of it were helping break up these plaques. They found that a tiny portion, some 0.1 percent of the mass, was in charge of the activity. Neurophage then took those pieces, built a fusion protein out of them called NPT002 with an in-house technology, and tested it in the petri dish just as it did with the virus. Neurophage found the same type of results in those experiments, and with animal models as well.
Even so, breaking up plaques in test tubes and animals is nothing compared to the exorbitant task of not only doing so in humans and proving it translates into a truly meaningful clinical benefit, but doing it safely. Neurophage plans to deliver the drug intravenously, through an injection once a month, and can look to the fact that fusion protein drugs like etanercept (Enbrel) are well established. And so far—in animal studies, of course—it’s been able to deliver NPT002 without seeing any big red flags for safety issues, like the compound sticking to organs it’s not supposed to, or homing in on different masses.
Still, it will take plenty of time, a lot of cash, and without question the help of a big pharmaceutical partner for Neurophage to get the ultimate proving ground of a huge Phase III clinical trial in either Alzheimer’s or Parkinson’s—the place where so many seemingly-promising drugs have failed.
So far, Neurophage has gotten some credible investors to back it, and has also been able to attract the interest of the Michael J. Fox Foundation, which has awarded the company two different grants to continue its research into breaking up Parkinson’s-related plaques. And Neurophage should complete another roughly $15 million Series D round—following the $6.4 million Series C round it announced in May—within the next couple months to get it to the point of submitting its first application to start clinical trials.
According to Solomon, Neurophage plans to begin its first clinical trial in the second half of 2015, through which it’ll likely use PET imaging to see if its drug candidate is reducing amyloid beta or tau in humans. Ideally, Neurophage would get a partner after Phase I trials that would help it run a big Phase II study in a large population like Parkinson’s or Alzheimer’s, while it handles a smaller study for a disease like Huntington’s, simultaneously, Solomon says. That’d allow the company to hedge its bet.