Parkinson’s disease clinical research in 7MM focuses on disease-modifying agents: GlobalData

Parkinson’s disease (PD) therapeutic landscape is heavily genericized, leaving substantial unmet needs in neuroprotective and disease-modifying therapies (DMTs). With current treatments largely focused on motor symptoms, the pipeline across the seven major markets (7MM*) highlights a growing emphasis on DMTs and non-motor symptom therapies, signalling a commitment to advancing PD treatments that address the full spectrum of patient challenges, says GlobalData.

Lorraine Palmer, Pharma Analyst at GlobalData, states, “There are a total of 93 products in Phase I-III development within the 7MM for the treatment of PD. 66 per cent of these are prospective neuroprotective agents or DMTs. These investigational agents target the key mechanisms that have been implicated in the pathophysiology of PD, such as alpha-synuclein aggregation and neuroinflammation, with the goal of slowing disease progression.”

Neuroprotective/DMT agents in in late-stage development include Annovis Bio’s Posiphen (buntanetap tartrate), which seeks to inhibit alpha-synuclein and is in Phase III development (NCT05357989) in the US and 5EU, and BioVie’s Triolex (bezisterim), an inhibitor of inflammatory mediators, which has a Phase III trial planned in the US due to its neuroprotective potential.

Palmer adds, “26 per cent of the pipeline DMTs in the pipeline target alpha-synuclein aggregation. This is a divisive mechanism of action, with some KOLs holding high hopes and others expressing scepticism, highlighting the failure of Prothena and Roche’s prasinezumab to meet its primary endpoint in the Phase II PASADENA trial (NCT03100149) and safety concerns due to the role of alpha-synuclein in healthy functioning.”

The key opinion leaders (KOLs) interviewed by GlobalData, however, agreed on the need for research to focus on the development of DMTs, while emphasising that a potential hurdle in their development is that the pathogenesis of PD can differ across patients. They also expressed enthusiasm for therapies addressing falls and non-motor PD symptoms, as this remains a strong unmet need in the field.

Palmer continues, “The 7MM PD pipeline demonstrates a significant research effort to address non-motor PD symptoms and postural instability. 18 per cent of the pipeline can be classified as ‘other antiparkinsonian agents,’ agents which emphasise symptom management beyond the core motor symptoms. Examples include agents such as Cerevance’s solengepras (Phase III; NCT06553027), which aims to improve postural instability in PD patients; IRLAB’s Pirepemat (Phase IIb; NCT05258071), which is under investigation for both postural instability and PD-dementia; and Silo Pharma’s psilocybin (Phase II), which targets depression and anxiety in patients with PD.”

The research focus on improving non-motor symptoms in PD patients is also highlighted by the fact that 3 per cent of the pipeline is specifically targeting PD-dementia and PD-psychosis. Research development into other antiparkinsonian agents, dopamine agonists, and treatments for PD-related dementia suggests comprehensive research outlook in the industry which aims to improve both motor and non-motor symptoms, addressing the broader spectrum of challenges faced by PD patients.

Palmer concludes, “The distribution of the 93 pipeline agents in the 7MM underscores a strong emphasis on neuroprotective and disease-modifying treatments, demonstrating an industry-wide focus toward therapies that could potentially slow the progression of PD.”

*7MM countries- France, Germany, Italy, Spain, the UK, the US, and Japan.