to make its pharmconutrients with industrial biological processes that use microbial hosts, like those of common biotech drugs, Afeyan says. It is focusing on amino acids that have been validated as having health benefits by scientists, which can be delivered as proteins in pills or drinks, which don’t spark allergic reactions, and which don’t taste awful. Pronutria’s plan is to move swiftly into human clinical trials with its protein drug candidates, and sidestep a lot of the usual preclinical work for new molecular drug entities, because its proteins are already components of the human diet that are considered GRAS—an FDA abbreviation for “generally regarded as safe.” By going ahead with GRAS proteins, the firm hopes to head down a drug development path that’s faster and cheaper than what most compounds have to follow today.
The first protein to emerge from Pronutria’s platform is one for sarcopenia, the name for muscle loss associated with aging. Another product candidate is being geared to help elderly people recover from falls, Connelly said. Others in the pipeline are being eyed for phenylketonuria, inflammatory bowel disease, and cystic fibrosis. Part of the secret in making these products work will be in getting the right dosages, the right ratios of amino acids, and getting them to the right degree of solubility, he said.
“We’re putting the pharmacology first,” Afeyan says. “If we don’t see a dose/response relationship, repeatability across many people, and proper controls, then we’re not going forward.” He adds: “Since it’s from food, we are making a product recapitulating the optimal amino acid compositions that people have tied to health effects.”
Just to use a popular example, it’s possible to come up with a pharmaceutical-grade version of Omega-3 fatty acids, and a dietary supplement form of the same thing, which call for quite different business models. The pharmaceutical forms would come at higher prices, be marketed to physicians instead of consumers, and rely on a different distribution system. Medical foods also come with different regulatory requirements and standards. Pronutria hopes to handle the different issues by leaning on partners, Connelly says.
There could be tons of competitors for Pronutria, and they would vary from protein to protein that it aspires to make. To his knowledge, Afeyan says no other company has been set up to create a library of the proteins in the human diet, with an eye toward making some of them into pharmaceuticals, medical foods, and dietary supplements. “There are places to call and order an amino acid drink or mix, but they’re very expensive, taste terrible, and are not specialized to your needs,” Afeyan says.
The biggest challenge at the startup?
“Focus,” Connelly says. “For me, this is a cross-indication platform. There are a lot of different places you could go with it. We’ve generated many leads. We’re closing in on 40 lead [candidates], across many different indications. Once you have these preclinically assessed, what do you take forward? We’re trying to assess areas to focus on.”
