Annovis Bio recently announced positive results from a Phase IIa trial of its pipeline asset ANVS401 (posiphen) in patients with early Parkinson’s disease (PD). The data presented further strengthens the previous interim trial findings, where ANVS401 showed an improvement in the overall motor skill functions of PD patients with no serious adverse events, says GlobalData, a leading data and analytics company.

GlobalData notes that while the early, preliminary data generated so far are promising and there is an established unmet need for novel treatment approaches in this space, Annovis Bio still needs to address concerns around the drug’s ability to provide therapeutic benefits in larger Phase III trials and the expected high cost of a first-in-class potential therapy, which will impact its future market entry. Given that, GlobalData anticipates that ANVS401 will generate sales of $161m in 2027 in the US, if approved.

Sarah Elsayed, Neurology Analyst at GlobalData, comments: “The role of neuroinflammation in PD has been increasingly explored over the past decade. In fact, a few companies have been investigating this approach to target PD patients at early stages of the disease, yet there are currently no available treatments that can offer neuroprotection or halt the disease progression. The announced data showed a highly statistically significant reduction in the levels of a number of different inflammatory biomarkers. As such, the advancement of ANVS401 into Phase III trials is a vital step towards providing further evidence to back up this hypothesis.”

Key opinion leaders (KOLs) interviewed by GlobalData* expressed that the α-synuclein pathway has been gaining increasing recognition among PD research, however, α-synuclein is mainly tested in cerebral spinal fluid (CSF), which adds a major difficulty in the process of collecting these samples during clinical trials.

Elsayed adds: “It remains challenging in clinical trials to differentiate between the symptomatic effects of drugs that target this approach and the potential neuroprotective properties. This is due to the difficulty to assess neuroprotective benefits in the absence of reliable biomarkers and the need to target patients earlier in the course of disease progression. Therefore, further research is needed to develop new therapies for the future PD market, given that the current options only offer symptomatic relief at moderate efficacy alongside their associated side effects.”

*Information taken from GlobalData’s report: Parkinson’s Disease – Global Drug Forecast and Market Analysis to 2029