Current treatments for advanced or high-risk prostate cancer are suboptimal due to limited efficacy, safety and convenience. In addition, some oral therapies require liver safety testing as well as co-administration of other agents, leading to significant dosing complexity and patient compliance concerns.
PRL-02 is a proprietary injectable product formulation designed to be a long-acting testosterone-suppression agent, which should lead to better compliance and perhaps improved efficacy and safety. Preclinical studies have shown long-acting effects on key efficacy biomarkers and a favorable safety profile, including decreased liver toxicity potential.
We intend to develop PRL-02 via the FDA’s 505 (b) (2) regulatory approval process, which will save significant time and greatly reduce costs. We anticipate filing an IND for PRL-02 in 2021, with potential market approval for this exciting product as early as 2024.
This long-acting injectable product has the potential to provide continuous testosterone suppression and therefore high efficacy without deleterious side effects. The product profile of PRL-02 is of significant interest to physicians and patients. An independent market research firm recently estimated the peak year sales of PRL-02 in the US at well over $1 billion.