Biotech Values

[biocqr]

VTVT > Dew, Peter and the board in general... I would love to hear your thoughts on this phase III AD trial for TP-488/Azeliragon which targets RAGE (Receptor for Advanced Glycation End-Products).

There are no other RAGE drugs under development in AD at present however there is some rationale for the target...

(2017) Ligands of Receptor for Advanced Glycation End-Products Produced by Activated Microglia are Critical in Neurodegenerative Diseases
https://goo.gl/3JAtvc

(2012) The Complexity of Sporadic Alzheimer's Disease Pathogenesis: The Role of RAGE as Therapeutic Target to Promote Neuroprotection by Inhibiting Neurovascular Dysfunction
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3310161/

TP-488 was discovered by Transtech Pharma and licensed to Pfizer. A phase 2b clinical trial was stopped due to the worsening of patients in the high dosage arm. The drug was returned to Transtech which morphed into VTVT. The CEO of Pfizer at the time was Jeffrey Kindler who was ousted in a reported boardroom coup...Kindler is now Chairman of the BOD of VTVT.

VTVT is claiming the trial was stopped prematurely and the futility analysis is suspect...

https://www.xconomy.com/raleigh-durham/2015/07/30/vtv-therapeutics-ipo-raises-117m-for-alzheimers-diabetes-drugs/

VTv claims that Pfizer’s decision to stop the azeliragon trial was premature, and that the study would likely have a different result if completed. The interim analysis used data from only 84 patients, rather than the full group of 266 patients. VTv says in its filings that the data had not undergone rigorous database monitoring and error correction, and that after correcting for errors, vTv and independent statisticians couldn’t replicate Pfizer’s analysis. In a presentation for the recent Alzheimer’s Association International Conference in Washington, D.C.—included among vTv’s filings—Marwan Sabbagh, chief medical officer/scientific officer for the Arizona Alzheimer’s Consortium, said the interim analysis was based on “a single snapshot, a single variable, and a single statistical model different than protocol planned final analysis.”

VTv is picking up where Pfizer left off. For the Phase 3 trial, the company has a “special protocol assessment”—an agreement with the FDA on the study’s design and how to analyze the data. Such agreements can minimize the chance that the regulator will reject the drug, as long as the trial meets the agreed upon study goals. In May, vTv began enrolling people in the 800-patient, two-group Phase 3 study. Each group of 400 patients will be randomized to receive the 5 mg daily dose azeliragon; the trial aims to study the drug’s effect on cognitive impairment in Alzheimer’s patients. The company expects to report initial data for the first group, in early 2017. Data from the second group are expected by mid-2018. The FDA has granted “fast track” status for the vTv drug, a designation reserved for drugs addressing unmet medical needs.

VTVT put these presentations together to justify their attempt to revive azeliragon in a new phase III trial...

http://www.vtvtherapeutics.com/assets/docs/Burstein_AAIC_2016_Azeliragon_Responder_Analysis_27July2016_final.pdf

https://www.sec.gov/Archives/edgar/data/1641489/000156761915000959/s000971x6_fwp.htm

Disclosure: I have a very tiny position in VTVT...I’m on the fence leaning towards dumping it and looking for any reasons to do so - lol.

They were supposed to report "initial data for the first group, in early 2017" which is nowhere to be found..that's probably reason enough to eject my small stake right there.