Redefining Treatment Paradigms for Advanced Parkinson’s Disease
Parkinson’s treatment has not really changed in over 50 years
Patients are typically treated with an oral levodopa (LD) – carbidopa (CD) combination to control their symptoms. This is an effective treatment in the early to mid-stages of the disease but over time patients develop dyskinesia (involuntary motor fluctuation) due to the phasic peak / trough nature of short acting LD. Patients with advancing disease inevitably become inadequately controlled by oral LD/CD and adjunct oral therapies, developing more frequent “OFF” time – where their existing medications simply do not allow them to perform even routine activities.
A significant unmet need for Continuous Dopaminergic Stimulation (CDS)
Approved and emerging alternatives that provide CDS in advanced patients are highly invasive products with significant quality-of-life limitations. These therapeutic approaches typically involve the patient wearing an electronic pump and tubing set 16 to 24 hours per day, 7 days per week to deliver a continuous infusion of LD/CD or apomorphine (a dopamine agonist). A home healthcare aide is usually required to set up, program, and maintain the device and to manage local infusion site reactions. Serina is positioning our SER-252 POZ Apomorphine drug candidate as a best-in-class product that overcomes all these limitations.
POZ Apomorphine is a potential Best-in-Class treatment for advanced patients
Apomorphine is similar to LD in terms of efficacy, but not dependent on the patient having intact presynaptic machinery to convert LD to dopamine. We anticipate entering clinical studies in 2025 with a product candidate that can provide CDS with no infusion pump, no adverse skin reactions and no healthcare aide needed to manage the therapy. Apomorphine drug approvals in the US have been limited to rescue indications, due to its short half-life and serious adverse local administration site reactions. SER-252 is a preventive (not rescue) therapy with the potential to increase “ON” time, decrease “OFF” time, prevent dyskinesia, and may allow some patients to titrate off all LD.
