Valley Fever Solutions, Inc. (VFS, an Arizona corporation), is developing Nikkomycin Z (NikZ) as a dramatically superior potential cure for Valley Fever. VF is a painful and debilitating orphan disease causing annually over 2,000 serious cases, 9K hospitalizations, and 150 deaths. About 60,000 people are sickened each year, suffering for months. Victims with more serious cases suffer for years. Each year, another 1,000 patients have serious disease - with no therapeutic options, as the current drugs do not work for them.
Collectively, the market for antifungals across a spectrum of similar disease organisms approaches $1B. Broadly, worldwide antifungal sales exceed $6B. NikZ for Valley Fever, our first indication, has Orphan Product designation. In 2014 we added GAIN Act QIDP designation. These provide for 7 and 5 years sequential market exclusivity after marketing approval. We expect to reach peak sales of $130M for Valley Fever fairly quickly with our many advantages over standard-of-care drugs. We expect therapeutic benefit in other indications in immunosuppressed patients, expecting a 2-3x market multiplier.
Our Phase I results were very promising. We are pursuing patents related to the new manufacturing process for NikZ. VFS is seeking a tranched A round or a partnership to reach proof of concept in late 2017. We could start a pivotal trial in late 2017 with support now.
We anticipate showing human efficacy working with an existing trial at the NIH. We are seeking $2M to conduct a small proof of concept trial much sooner in a small population of more typical subjects, our "sweet spot" trial. We are making progress under an NIH grant to conduct a clinical trial in patients with new infection, a trial we hope to begin in late 2017. An NIH contract delivered some GMP product by an older process.
We are scaling up our pilot scale process to make a large batch of new trial material (API and drug product) in May 2017. We will begin Phase IIa patient enrollment shortly after having trial material, anticipating results 3-6 months later, and early results within the first 2 months (endpoint confirmation). With investor support, the sweet spot proof of concept trial could give results as soon as Fall 2017. Such private funding would accelerate the NIH proof of concept path by a year or more. We expect to be a good candidate for an additional $2M FDA orphan product trial grant in 2018.
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