Current treatments for advanced or high-risk prostate cancer are suboptimal due to limited efficacy, safety, or compliance. In addition, oral abiraterone acetate therapies require high daily doses and liver safety testing as well as co-administration of other agents, leading to a complicated dosing regimen and patient compliance concerns.
PRL-02 utilizes a unique patented prodrug of the abiraterone active pharmaceutical ingredient (API) in an injectable product formulation. The clinical formulation has been proven in nonclinical models to be a long-acting testosterone-suppression agent with an improved safety profile (including decreased liver toxicity), which in combination should lead to better compliance. The PRL-02 product profile is of significant interest to physicians and patients. Propella presented its findings from nonclinical studies at the prestigious annual American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2021.
We will file an Investigational New Drug Application (IND) for PRL-02 in 2Q 2021, with potential market approval for this promising product as early as 2024.
An independent market research firm recently estimated the peak year sales of PRL-02 in the US at more than $1.5 billion.