- Aimmune Therapeutics Inc AIMT shares are down 30 percent in the last three months, having declined steadily from a high of $26.05 on August 14.
- Piper Jaffray’s Charles C. Duncan maintained an Overweight rating on the company, while raising the price target from $35 to $38.
- PALISADE Phase III trial is to commence earlier than expected and peanut allergy candidate AR101 could gain approval in the US and the EU, Duncan stated.
Analyst Charles Duncan mentioned, “We hosted Aimmune management with investors and gained incremental understanding of clinical trial execution and potential differentiation for lead peanut allergy candidate AR101.”
The Phase III PALISADE trial appears to be on track to open sites and enroll patients possibly in December. Duncan said that this is earlier than the expectation of a 1Q16 start. The earlier start of the trial makes Aimmune’s trial timeline more in-line with mind-share competitor DBV Technologies SA DBVT, for which Phase III is expected to commence in 4Q15.
Aimmune plans to open trial sites in the US, Canada, and in the EU. “We did not necessarily anticipate the inclusion of 15 or more EU sites, and we believe European regulators may require a higher level of protection from desensitization immunotherapy than the FDA, possibly on the order of 2,000mg,” Duncan commented.
Compared to competitive candidate Viaskin Peanut, AR101’s mechanism could produce this level of protection based on the Phase II data released so far. Aimmune has guided to complete PALISADE trial data in 3Q17.
In the report Piper Jaffray noted, “AR101 clearly better serves the needs of the severely allergic patient by providing life-saving protection in a relatively short time period, establishing consistent protection at levels which are clearly clinically meaningful to regulators, and likely working in a broad set of age groups including adults.”
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