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 over 2,000 serious cases, 8K hospitalizations, and 150 deaths a year. About 60,000 people are sickened each year, suffering for months. Victims with more serious cases suffer for years.
Collectively, the market for antifungals across a spectrum of similar disease organisms approaches $1B. This 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.
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 in 2016 to reach proof of concept. We could start a pivotal trial in 2017 with support now. We have a "fast track" plan to proof of concept in 15 months for <$5M, and an aggressive plan for <$2.5M.
We anticipate showing human efficacy working with an existing trial at the NIH, possibly within 4-6 months after getting trial material. We were awarded an NIH grant to conduct a clinical trial in patients with new infection. We hope to begin this trial in late 2016. An NIH contract is moving towards delivering GMP product in about mid 2016.
We are prepared to scale up our successful pilot scale process and make a large batch of new trial material (API and drug product) in 12 months, with a useful amount of initial trial drug product after 7 of those 12 months. 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 (effect finding). With investor support, the proof of concept trial could give results as soon as early 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 $1.5M FDA orphan product trial grant in 2017.
1830 E. Broadway, #124-182
Tucson, AZ 85719
January 11, 2016, 3:30 pm, Davidson -
VFS at Biotech Showcase
Temple at Nikko, Japan where the organism that produces Nikkomycin-Z was discovered