Hops give a distinctive bitter taste to beer, which has been known to cause many a drinker to pack on an extra pound or two. But a Seattle-based startup called KinDex Pharmaceuticals thinks a chemical in these plants might just help people shed weight–and even control their diabetes.
KinDex is announcing today that it’s raised a $5 million Series A round. Polaris Partners, Paul Schimmel (of the Scripps Research Institute), Metagenics co-founder Jeff Katke, and KinDex president and CEO (and former Metagenics executive) Jeffrey Bland are providing the cash. KinDex aims to double the size of the round within the next year and close it out at $10 million, according to Bland.
The cash will help the startup kick off a Phase 2 trial testing its lead drug, KDT501, in people with Type 2 diabetes. The drug is a derivative of an extract of hops that KinDex serendipitously found to play a role not only in quelling an immune response related to fatty diets and diabetes, but potentially in weight loss as well.
KinDex traces its roots back more than a decade, when Bland, then the president of Aliso Viejo, CA-based medical foods company Metagenics, decided that Metagenics should start screening natural products for anti-inflammatory capabilities. Oddly enough, after screening hundreds of products, Metagenics found extracts of hops to be the most active. So Metagenics set up a division to look into the cellular biology of these compounds and figure out how they were helping to curb inflammation.
In doing so, Metagenics found that these hops extracts seemed to have an impact on a network of enzymes that help the body regulate glucose transport and management, and insulin sensitivity. Specifically, Bland says, the molecules appeared to neutralize some of the inflammatory responses that are triggered when, in response to a high-fat diet, bacteria in the gut release molecules called endotoxins. Left unchecked, the inflammation can lead to what’s known as insulin resistance, when the body doesn’t properly absorb glucose. But by blunting this type of immune response, the hops molecules seemed to have the ability to normalize glucose levels, Bland says.
In surveying the existing scientific literature, Bland says, Metagenics found that the biology of those molecules hadn’t really been studied very much. “This was like, the dream for a scientist that you can serendipitously fall into something that hadn’t had a lot of work done on it,” he says.
Scientists at Metagenics then published a number of papers on the hop plant’s cell biology, and found that some of the extracts from the plant were more effective at things like normalizing blood glucose in diabetic lab mice than others. After finding and refining the molecule it believed to be doing the “biologically heavy lifting” in the hops, Metagenics spun out the project in September 2009 with the help of a $20 million loan from consumer products company Alticor, according to Bland. The company, called KinDex Therapeutics, then developed what became KDT501: a derivative of hops modified by a few steps of chemistry.
“It’s now a compound that actually can be tested as a drug,” Bland says. “We were the first to develop a pharmaceutical grade new chemical entity from these hops materials.”
KinDex filed an investigational new drug application, conducted animal studies, and then an early Phase 1b study to assess KDT501’s safety with the help of the Alticor loan. KinDex even found another interesting potential benefit to the drug along the way. It appeared to promote weight loss by indirectly affecting “brown fat,” a type of tissue that helps mammals burn off the commonly known “white fat” tissue that stores excess energy.
With the early work behind KinDex, it was time to really see if the company had a drug that could benefit human patients. So the company enlisted a partner with a “broader expertise” in pharmaceutical development—Polaris—to help fund and advise it as it prepped for a mid-stage clinical trial, according to Bland. As part of the round, KinDex recapitalized and changed its name from KinDex Therapeutics to KinDex Pharmaceuticals, and moved from an LLC to a C-corp structure. Alticor is still a stockholder, but KinDex negotiated a “friendly” deal where it would only have to pay back a portion of the loan.
“We needed really to move to someone who really understood this space and could assist us with the appropriate strategic direction,” Bland says of the shakeup.
KinDex envisions running a roughly 200-patient mid-stage study in which patients with type two diabetes and a “modestly increased” body mass index would get either KDT501 on its own, KDT501 in tandem with the commonly used diabetes drug metformin, or just a placebo. The reason for this study design is KinDex envisions its drug as an add-on that could counteract some of the side effects of metformin and other type 2 diabetes drugs. Adding KDT501 could also reduce the dosages required for some of the other drugs, Bland says.
Should KinDex get the results it hopes for in the coming study, it could pave the way for a partnership with a big pharmaceutical company that could pick up the tab for a pricey Phase 3 study. But given the heavy competition in the diabetes and obesity spaces, KinDex knows it’s got to deliver something stellar, not just decent, to achieve its goals.
“Getting your signal above the noise in this space requires something quite remarkable both in terms of mechanism of action, safety, and clinical efficacy,” Bland says. “We’ve gotta fulfill those criteria.”