Sola entered P3 on biomarker results alone with no evidence of clinical benefit.
[Lilly Chief Executive John Lechleiter cautioned in an interview that observers shouldn't "over-interpret" the decision to complete the trials, and that it remains to be seen whether solanezumab is safe and effective.
"This remains a very high-risk area of research," Jan Lundberg, president of Lilly Research Laboratories, told analysts on a conference call.]
Retiring Lilly Chief Executive John Lechleiter (an organic chemist who became a businessman) is being replaced by David Ricks, who comes from a commercial background. He holds a bachelor’s degree in business from Purdue University and an MBA from Indiana University, announced in July this year. As exec VP he had been overseeing the AD program.
[Ricks has a background in doing deals, and he anticipates doing more of that when he takes over as CEO.
“I have some passion for that area,” he said of mergers and acquisitions, but added that the company isn’t looking for large-scale deals. “We’re interested in pipeline collaborations or acquisition of companies that have assets we’re interested in.”] http://www.bloomberg.com/news/artic...ter-to-retire-will-be-replaced-by-david-ricks
That is a big difference between PBT2 and Sola. PBT2 produced stat sig executive function evidence over both AD and HD at phase2 level. That was reinforced by the results of an HSG developed test of patient reported improvements over just 6 months in HD. To see evidence of clinical efficacy in AD AND HD in a Phase2 is a pretty big deal IMO.
From a 2015 Study of AD trials.
Schneider et al. [2] have pointed out that, to date, no anti-amyloid phase III study has been preceded by a positive phase II proof of concept study. Instead the decision to move to phase III has at times been made based on positive data on effects on biomarkers rather than clinical endpoints: an example here is that of solanezumab [2], where after entering phase III studies based on biomarker and safety data in phase II, the first phase III results did not reach statistical significance (though the study led to design of the further ongoing phase III study in mild patients). Moving to phase III based on positive clinical results in subgroups but not the overall analysis in phase II also carries significant risk as exemplified by the failure in phase III of tarenflurbil in mild AD, a subgroup with apparently positive results in phase II [11]. The motivation to skip phase IIB studies prior to entry into phase III for the newer disease-modifying agents may be prompted partly by the long duration of such studies and the drive for commercial organisations to enter the market as early as possible. Another factor behind the leap into phase III may be concern over issues around statistical power in phase II. Of course, the sample size estimation is dependent on both the magnitude of the response and associated variability - which may be conveniently combined into an ‘effect size’ consisting of the mean difference between active and control groups divided by the standard deviation of the difference. Continuous development failures in the AD field have led to more cautious anticipated effect sizes - with consequently larger predicted sample sizes needed to show them. https://alzres.biomedcentral.com/articles/10.1186/s13195-015-0153-y http://onlinelibrary.wiley.com/doi/10.1111/joim.12191/full
Maybe Ricks would consider a partnership now. It is looking bad for the monoclonal antibody pure AB removal drugs. Prana have a phase3 ready ionophore with a very different MOA to Sola and encouraging P2 results, with just a small FDA objection to negotiate
LLY have spent 3 decades and $3B leading up to this failure, and they have been determined to find an AD answer "in house". With this failure following the 1600 patient Phase3 semagacestat disaster which increased cognition loss, maybe they will look outside.
PBT Price at posting:
5.7¢ Sentiment: Hold Disclosure: Held
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