Annovis glosses over primary endpoint in pivotal Parkinson’s data, focuses on subgroups

Annovis Bio has published its delayed phase 3 Parkinson’s disease data, reporting success in subgroups and secondary endpoints while skirting the question of whether the candidate moved the needle on the main goal.  

Pennsylvania-based Annovis enrolled 523 early Parkinson’s patients to show if six months of daily dosing with buntanetap improves scores on the MDS-UPDRS disease rating scale compared to placebo. Yet, the company’s press release leads with the effect of buntanetap on cognition and follows up with details of changes in MDS-UPDRS in subpopulations of patients. 

Annovis linked the higher of the two tested buntanetap doses to a statistically significant improvement in cognition compared to placebo. None of the five secondary endpoints listed on relate to cognition, although the description of the study said it would be assessed using the MMSE measure.  

The biotech focused its discussion of the primary goal on subpopulations. Assessing the effect of the drug candidate proved “challenging,” Annovis said, because patients who were diagnosed less than three years ago had “minimal or no deficits in MDS-UPDRS Part II.” The measure looks at activities of daily living. Annovis recently removed Part III, a motor exam, from the primary endpoint, citing FDA feedback.

Faced with the challenges of assessing efficacy, Annovis zeroed in on subpopulations of patients to try to show that buntanetap works. The biotech reported significant improvements on MDS-UPDRS Part II and III in 158 participants who were diagnosed more than three years ago, as well as in a subpopulation of patients with postural instability and gait difficulty.

The readout ends the wait for the data. Annovis previously told investors to expect the data by the end of January. Days before the deadline, the biotech delayed the readout because of “ongoing data cleaning efforts to ensure the accuracy and reliability of the study results.” In May, Annovis set a June target for the publication of topline efficacy data.

Investors didn't seem convinced by today's results, sending the biotech's stock down 9% to $4.79 in the opening hour of trading on Tuesday.