Starting March 2018, VFS engaged a manufacturer to make large pilot scale clinical trial material. We are preparing to undertake large scale manufacture. This is an important milestone to set up proof of concept trials in 2019.
The FDA will review the VFS progress, and plans for Phase 2 trials. This is an important milestone to set up proof of concept trials in 2019.
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 disease organisms generally simlar to cocci exceeds $1B. Broadly, worldwide antifungal sales exceed $12B. 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 sales of $50M quickly and 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 substantial revenue mutiplier.
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 2019. We could start a pivotal trial in May 2019 with support now. We anticipate an independent showing of human efficacy working with an existing clinic at the NIH.
We are seeking $10M to conduct a small proof of concept trial much sooner in a small population of more extreme subjects, our "sweet spot" trial. We want to address in particular patients with significant disease and who cannot use existing drugs.
We are scaling up our pilot scale process to make a large batch of new trial material (API and drug product) in early 2019. We will begin Phase IIa patient enrollment shortly after having trial material, anticipating results 6-9 months later, and perhaps some early results within the first 2 months (endpoint confirmation, some dose ranging). With investor support, the sweet spot proof of concept trial could give results as soon as Q4 2019. We expect to be a good candidate for an additional $2M FDA orphan product trial grant in 2019.
1830 E. Broadway, #124-182
Tucson, AZ 85719
â Mail: info@ValleyFeverSolutions.com