Replies to post #65386 on Anavex Life Sciences Corp (AVXL)

[Mikesc]

Imagine spending all that $$$$ on developing a drug and along comes a small biotech company (small printing firm) that has a drug the will make your drug obsolete before you get it to market... I am loving this...

[F1ash]

It looks like Lilly has taken a pretty long time to advance their drug. One phase 2 was ~7 years ago.

Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers

First received: May 19, 2006
Last updated: October 5, 2009
Last verified: October 2009

Sponsors and Collaborators
Eli Lilly and Company

https://clinicaltrials.gov/ct2/show/NCT00329082?term=Solanezumab&rank=11


https://clinicaltrials.gov/ct2/results?term=Solanezumab&pg=1



Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: LY2062430: Multiple-Dose Safety in Subjects With Mild-to-Moderate Alzheimer's Disease and Single-Dose Safety in Healthy Volunteers

[bas2020]

from another board...

SOL failed twice. They keep changing the endpoints and keep making the patients earlier in the disease hoping for some improvement. In the latest P3 trial, there was no difference between SOL and placebo in Activities of Daily Living functional scale, basic items of the ADCS-ADL, and Clinical Dementia Rating. The two Phase III trials were EXPEDITION 1 and EXPEDITION 2. EXPEDITION 1 didn't meet the predefined assessments. Lilly changed the predefined study goal in EXPEDITION 2, but EXPEDITION 2 didn't meet that goal either.
An ex-FDA official told the Financial Times that solanezumab "does not have a snowball’s chance in a very hot place" of getting conditional approval. To the FDA, missing the primary endpoint in a Phase III trial is "fatal" (from Financial Times)