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A Powerful Platform for Patient Outcomes

POZ Changes The Treatment Paradigm For Parkinsons Disease.

Parkinson’s treatment has not really changed in 50 years. As many as ten million people worldwide may be affected by the disease. Patients with advancing disease frequently develop “OFF” time – their existing medications simply do not allow them to perform even routine activities. They are invariably treated with Levadopa (L-DOPA) to control their symptoms. L-DOPA is an effective treatment in the initial stages of the disease but over time patients develop dyskinesia (involuntary motor fluctuation) due to the phasic peak / trough nature of short acting dopamine drugs.

A significant unmet need for CDS

Apomorphine (a dopamine agonist) is an effective drug in advanced disease – capable of rescuing “OFF” periods within minutes. FDA approvals of apomorphine to date have been limited to rescue therapies that do not provide continuous dopaminergic stimulation (CDS). These apomorphine formulations are confounded by severe skin reactions. Other approaches include delivery of apomorphine via a continuous subcutaneous electronic infusion device worn all day, every day. This typically requires a health care provider to set it up daily, constantly moving the infusion site given the severity of the skin reactions.

SER-252 is a potential breakthrough therapy for advanced disease.

We anticipate entering clinical studies in 2025 with a twice per week subcutaneous injection of apomorphine that has the potential to reduce “OFF” time, with no adverse skin reactions and no need for a doctor or nurse to administer it. SER-252 is a preventive therapy (not a rescue therapy) with the potential to increase “ON” time, prevent dyskinesia, and may allow some patients to titrate off all L-DOPA. Leveraging our partnership with Enable Injections, SER-252 is being developed using enFuse®, the innovative wearable drug delivery platform from Enable that allows patient self-administration with rapid treatment time.