Valley Fever Solutions
Bringing New Hope to an Orphan Disease
FDA orphan designation: NikZ for cocci indication OOPD - 7 years market exclusivity QIDP - additional 5 years market exclusivity
2020 edits pending.
These June 2019 attachments are relevant, but will be updated
1/13/2020 Interview perspective
NikZ is a new class of antifungal
NCE New Chemical Entity
Novel Mechanism of Action (MOA) among commercial antifungals,
interferes with chitin synthase
Selective to fungal cells - nontoxic to mammals
Valley Fever sensitive to NikZ as monotherapy
Enhances other anti-fungal treatments as combination
Good preclinical results in reliable models
Excellent results in animal model highly correlated with human results Several pet dogs responding well
Phase 2a Trial Plans
Need support: Phase 2a Proof of Concept:
- small group of typical, long suffering patients
NIH supported: Phase 2a Proof of Concept:
- current patients unresponsive to best available treatments
NIH supported: Phase 2a Proof of Concept:
- patients with first signs of infection (early intervention)
