Summer Street Reports Concerns Over Afrezza Affinity 1 Studies

Shares of MannKind (NASDAQ: MNKD) are down approximately 2 percent amid comments from Summer Street analyst Bart Classen.

Classen reported in an interview that MannKind's briefing documents may be “problematic” regarding Affinity 1 studies on the Afrezza Dreamboat insulin inhaler. The analyst questioned if Affinity 1 was a “proper bridging study” as there are “inconsistencies” in the data. Classen further examined and questioned if the Afrezza inhaler is noninferior to injectable insulin and equivalent to Medtone C inhaler.

On March 26, 2014, Summer Street hosted a tech assessment to preview the April 1 inhaled insulin AdComm panel. At the assessment, Summer Street said to expect a cautious and negative briefing document with the FDA, specifically detailing the history of inhaled insulin setbacks including two prior MannKind CRLs and the Exubera experience.

The firm added that the FDA will have substantial issues with the Medtone C arm of trial from the old device and the bioequivalence bridging to the new Dreamboat inhaler.

In August, Bart Classen voiced his concerns over the Affinity 1 trial. The analyst said that MannKind's Affinity 1 trial results are seen as “suspicious”. On August 19, Classen remarked that he was “confident FDA won't approve Afrezza Dreamboat inhaler without new, large clinical trials.”

Shares of MannKind fell as much as 10.4 percent on Thursday to $4.87. The stock has slightly rebounded and is currently trading at $5.20, down 3.35 percent.