Current therapies for herpes labialis (e.g., cold sores and genital lesions) are lacking in efficacy, convenience, or safety. Marketed topical products are generally considered safer than oral products but have limited efficacy requiring four or more application per day. Preclinical studies have demonstrated that PRL-01 is more rapidly absorbed into the affected skin and may be significantly more efficacious than current therapies leading to a longer duration of response and improved patient outcomes with fewer daily applications. Moreover, PRL-01 is a clear, easy-to-apply, aesthetically pleasing topical formulation designed to be devoid of the grittiness or telltale mess associated with most ointments and creams.
We intend to develop PRL-01 via the FDA’s accelerated 505 (b) (2) regulatory approval pathway. We anticipate filing an IND for PRL-01 in 2021, with potential market approval for this life-enhancing product as early as 2024.
An independent market research firm recently estimated the US market for the topical treatment of herpes labialis at over $1 billion. A topical product with the profile of PRL-01 has significant commercial potential and would be expected to capture a significant portion of this lucrative market.