VTv Therapeutics Inc. released data showing the second part of a late stage study on its experimental Alzheimer's drug azeliragon failed to meet goals.
But the early stage biopharmaceutical company is not giving up on the therapy — it will be discussing ways to advance azeliragon toward a regulatory approval with the U.S. Food and Drug Administration based on data collected so far, it said in a news release.
"We are eager to obtain early feedback from the FDA based on the results we have achieved and the data that we have observed associating lower plasma levels of the drug and improved efficacy," CEO Steve Holcombe said.
"As a result, we believe that azeliragon has the potential to address the pressing unmet need in Alzheimer's disease," he added.
Azeliragon is being developed under a Special Protocol Assessment process following an agreement with the U.S. Food and Drug Administration in 2014. The process is a binding agreement with the FDA that the phase 3 trial design, planned execution and data analyses are acceptable to support regulatory approval. The drug was also granted a fast track designation.
In part A of the phase 3 trial, dubbed Steadfast, azeliragon had failed to improve cognitive or functional outcomes versus placebo. At that time, vTv had said it would discontinue all current clinical studies involving azeliragon, including an open-label extension study.
The results from part B released June 12, follows close on the heels of Eli Lilly and Co. and AstraZeneca PLC halting trials for lanabecestat.

Alzheimer's disease, an ailment that has long stumped researchers and drug developers, causes progressive decline in memory and cognition.
While there is no cure for the disease yet, the pharmaceutical industry has been fighting an uphill battle to get a drug in the market, spending billions of dollars in failed trials in the process.
Notable Alzheimer's disease studies that are still ongoing include Biogen Inc.'s aducanumab and Eisai Co. Ltd.'s elenbecestat.
