Pharma, BioPharma

Can deconstructing the biological clock help treat diabetes and cancer?

Rhode Island biopharma company VeroScience aims to understand Circadian rhythms, harnessing the biological clock to treat diseases like type 2 diabetes and cancer.

The evolutionary underpinnings of diabetes are actually quite strong: Animals go through cycles in which their metabolism changes. Animals become obese and insulin-resistant when food availability is very low, and their metabolism kicks into gear when the environment is flush with food.

This all aligns with Circadian rhythms, Rhode Island-based biotech VeroScience asserts, which is why it’s developing its line of therapeutics around the waxing and waning of mammal metabolic function. In short, it’s studying how the biology behind the hibernation patterns of a bear, or the mating patterns of a bird, might be harnessed to spark new therapeutic modalities.

But what’s the best application for this science?

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The private company has had a diabetes drug called Cycloset approved by the Food and Drug Administration since 2009, and is expanding its research into cancer, as well as reproductive and immunologic disorders. Here’s how the company describes its approach:

By investigating and mimicking nature’s means of regulating biochemical physiology for survival of vertebrates in the wild, VeroScience develops treatment strategies, not products per se, aimed at re-directing pathological biochemistry back towards its “normal” physiological organization.

The idea is that even in our own brains, the change in seasons impacts our neural networking. Our brain activity in the winter is wildly different than in the summer, and it’s also different in the morning than at night. This biological clock works as a controlling circuit for neuroendocrine physiology in the whole body, said Anthony Cincotta, chief scientific officer at VeroScience.

“If we can change those signals to the biological clock, we can reset the the output to the rest of the tissues in the body,” Cincotta said. “Realigning the Circadian rhythms can reprogram the whole body’s physiology.”

The company’s examining how changes in the sleep/wake cycle and social stress might impact an individual’s neural circuitry – and how that ultimately impacts their molecular physiology.

In its cancer study, for instance, VeroScience is finding that one can reset the immune system’s biological clock – helping regulate immune function. By controlling the timing of the release of different immune agents – say, the T cell – so they activate all at once instead of at different times, ostensibly one could amplify the defense systems against cancer, Cincotta said.

“We want to orchestrate and organize the entire immune system to fight off the cancer,” he said. “That’s what we’re doing through the brain.”

This is an interesting premise for drug development, sure – though the FDA has said that it hasn’t found conclusive evidence on what it is about Cycloset that lowers blood sugar.Cycloset was found in a 3,070-patient study to lower blood sugar, without adverse cardiac events. It’s meant to be used as an add-on treatment to more standard therapeutics like metformin.

This is interesting, however: Cycloset’s been on the market since 2011, and is being co-marketed by Valeant Pharmaceuticals. It’s had a bit of a rocky go of it, though – its first marketing partner was Santarus in 2011, but that was acquired by Salix in 2013. Then, this year, Salix was acquired by Valeant in March this year – sort of upsetting the continuity of marketing partner.

While Cincotta wouldn’t comment on Cycloset’s sales, it’s a fair conclusion to make that improving the public face of its long-approved diabetes drug could only help its standing with its new big pharma partner. Valeant doesn’t have a strong stake, after all, in the diabetes market.

“We’ve partnered with progressively larger companies since Cycloset was approved, and we’re hopeful this will get information and medical education on the therapy out to a broader spectrum of health professionals,” Cincotta said.

Other applications for VeroScience’s core research are in agriculture and helping save endangered species – resetting the biological clock of an animal in a zoo so they can breed in captivity, for instance. This leaves one to wonder which direction this biopharma company will take. There seems to be a great deal of promise, however, in the prospect of better harnessing the biological clock.