Meet the Unnoticed Alzheimer's Biotech Facing a Make-or-Break 2018

It seems that the primary news surrounding Alzheimer’s disease research has been nothing but negative for years. Phase III failures, discontinuing research and development have dominated the headlines. But one company is hoping to break that trend with two Phase III readouts this year. If successful, that will put vTv Therapeutics ahead of other pharma companies, such as Biogen, Eli Lilly and Merck, anticipating their own Alzheimer’s drug readouts in 2019 or 2020.

In an interview with MedCity News, vTv Therapeutics Chief Executive Officer Stephen Holcombe said positive news for drug candidate azeliragon means the company could field a product by 2019 – making it the first to do so in 15 years. vTv’s azeliragon has fast-track approval, which could shorten the amount of time it takes to hit the street should it successfully pass both late-stage trials. Data from the first Phase III trial is expected in the first quarter of the year and the second trial is expected in the second half of the year.

High Point, N.C.-based vTv discovered azeliragon, a novel orally active small-molecule antagonist of RAGE, through its proprietary drug discovery platform TTP Translational Technology. In its research, vTv said research has shown that receptor for advanced glycation endproducts (RAGE) activation contributes to the pathogenesis of Alzheimer’s disease. "Sustained Amyloid-β interactions with RAGE at the blood-brain barrier (BBB) and in neuronal and microglial cells, play potentially major roles in amyloid plaque formation, neuroinflammation and chronic neural dysfunction," which are all hallmarks of Alzheimer’s disease, according to company data.

Although Eli Lilly’s data analysis of its failed Phase III Alzheimer’s disease treatment solanezumab has given some the idea the amyloid plaque thesis in Alzheimer’s is dead, vTv is not deterred. In the interview with MedCity News, Holcombe pointed out that both amyloid plaque and tau, the other big theory, are part of the "RAGE paradigm," which could give his product a leg up where others have failed.

Holcombe noted that azeliragon, which has been in development for 18 years, would likely be used as a preventative treatment. The therapy could not reverse any damage from Alzheimer’s, but it could slow progression of the disease.

In Phase IIb trials, azeliragon provided statistically significant benefits to patients with mild and mild-to-moderate Alzheimer’s patients. Over the course of 18 months, patients with mild Alzheimer’s registered a 4.0 point improvement on using the ADAS-Cog11 assessment scores. The patients with the mild-to-moderate diagnosis also fared well, scoring 3.1 improvement, MedCity News said.

With both trials set to read out later this year, it’s for sure that large pharma companies will be keeping a close eye on the data. Holcombe himself said that there is "no lack of interest" from big pharma.

"They know this trial is reading out. They see that this is a drug that can be added on to the standard therapy. It can be used down the road, potentially, in combination with what they’re working on," Holcombe told MedCity News.

Alzheimer’s and other forms of dementia are a growing healthcare concern. In the United States, Alzheimer’s disease is the sixth-leading cause of death across all ages and the fifth-leading cause of death in people over 65 years of age. By 2050, the number of global patients is expected to hit 131.5 million.

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