vTv Therapeutics Inc (NASDAQ:VTVT) up close to 10% on the release of top line data from its lead type 2 diabetes trial, and daily volume suggests the run is just beginning. Here’s what happened in the just reported trial, and what we’re looking for going forward from the company and – specifically, the program in question.
So, the data relates to a drug called TTP273 that, as mentioned, is under investigation as a type 2 diabetes treatment. This sort of diabetes derives from (or maybe its better to say comes about as a result of) the body’s inability to use insulin properly to control sugar in the bloodstream. It’s vastly more common than its type 1 counterpart, circa 95% of all diabetes patients are phase 2, and it’s the 7th leading cause of death in the US. It’s an issue, but its manageable, by way of what are called GLP-1 therapies. These therapies activate GLP-1 receptors, and in doing so, lead to the enhancement of insulin secretion, the suppression of glucagon production and decreased food intake. There’s an issue, however, and that’s route of administration. The current available SOCs are all injectable, and while these injections are fine for self administration, many people have problems with staying true to a dosing regimen. This creates more issues, and eventually leads to the above mentioned deaths.
So, vTv is a junior biotech, and it’s trying to bring a product to market that will solve the above mentioned dosing regimen issue – an oral GLP-1 drug. Oral insulin is the holy grain of the diabetes space, and this is a close second, if not on an equal footing. A company that can bring an effective form of oral insulin to market has itself a golden ticket.
The biggest problem these companies face is degradation. When these pills pass through the digestive system, the active ingredients degrade, and become useless. vTv reckons its pill is orally bioavailable through a technology called TTP Translational Technology, and it’s out to prove it with the ongoing program.
So what did the data show?
It’s phase II, so mid stage, and enrollment totaled 174. All patients, already on stable doses of metformin (which is a widely used as a first line SOC in this indication) were randomized to receive either placebo or TTP273 at doses of 150 mg once or twice daily. Both dose regimens translated to mean placebo-subtracted HbA1c (HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration) differences of -0.86 percent and -0.71 percent, respectively. Concurrently, HbA1c increased by 0.15 percent in patients randomized to placebo. Additionally, and as a sort of off the record kicker, trends were observed with patients losing on average 0.9 kg and 0.6 kg in the once and twice daily arms, respectively.
All said, these are excellent numbers. We think markets have somewhat under-reacted to their implications. Admittedly, they are a little vague right now. Safety and tolerability data is thin, and the numbers that underlie some of the secondary points are yet to be put out. However, with the top line as is, we expect that the full analysis will fall in line with the top line data.
Cash is incredibly strong for a company of this size ($51 million at last count) and debt is nonexistent. Dilutive financing is out of the way for now, and the company is pushing both this trial and a just announced preclinical Parkinson’s candidate to provide catalysts over the coming twelve months.
Bottom line, we like this one. It’s got a sound balance sheet and a promising drug in a huge indication. Catalysts will drive value going forward, so we’re going to be watching the company closely for clarity.
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Disclosure: We have no position in VTVT and have not been compensated for this article.