Valley Fever Solutions

Nikkomycin Z -
- Expanded Indications include Candida, Aspergillus
- NikZ suppresses Valley Fever in very sick dogs
- Dr. Larwood completes his PhD
- New Web Page Design Arriving Soon!

Nikkomycin Z (NikZ) is first in a new class of antifungal

• Novel mechanism of action, expected to raise the standard of care against many fungal infections
• Recent animal tests confirm 100% survival against dissemianted candidiasis and (in combination) aspergillosis
• Oral dosing completely suppresses brain infection (Coccidioides)
• New formulation gives still higher benefit, and at doses 90% lower
• Selective against fungal cells - thus far no safety concerns in mammals
• Enhances other anti-fungal treatments in combination with other drugs
• Scaled up trial material, Phase IIa trials in sick humans ready to proceed in next round

News Highlights

• June 2024 Congratulations Doctor Larwood! Now a UCSF PhD
• April 5, 2024 68th Annual Coccidioidomycosis Study Group  
• NikZ Success Against VF in Naturally Infected Dogs –  Slides


• Feb 28, 2023 Biocom Global Investor Conference  
• Update on NikZ test progress  –  Presenters  


• January 2023 - Mycology (Journal) NIKZ effective against Candida albicans
• Nikkomycin Z against systemic candidiasis significantly suppresses fungal growth, giving 100% survival

  David Larwood Interview at Biotech Showcase

      Our CEO explains our driving inspiration.    
    "Cure" is a big word in human therapy, something we seek to approach, but something notoriously difficult to prove. We anticipate reducing relapse in at least many humans, and look forward to the day of no relapses. We have seen no relapse a year after therapy in three seriously ill dogs with natural infection, accepted as highly representative of human disease and outcomes. Fungicidal levels of NikZ have been found in most pre-clinical studies, eliminating detectable Valley Fever residual fungus.

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  Valley Fever Solutions, Inc. (VFS, an Arizona corporation), is developing Nikkomycin Z (NikZ) as a dramatically superior therapy for Valley Fever (VF). VF is a painful and debilitating orphan disease causing annually over 2,000 serious cases, 9K hospitalizations, and 150 deaths. Aggregate costs of VF in California are $700M, and in Arizona another $700M.
    About 60,000 people are sickened each year, suffering for months. Victims with more serious cases suffer for years. Each year, another 2,000 patients progress from mild infection to disseminated VF, a very serious condition. About half of these cannot take current drugs, so they have not therapeutic options and simply have to suffer. This is our core target market. NikZ is well tolerated, so we expect a significant shift from current therapies to NikZ.

  NikZ has been shown to be effective against chronic disseminated disease in dogs. Valley Fever in dogs and humans is similar in incidence, diagnosis, symptoms, therapies, and responses. This benefit in dogs is likely to be found in humans as well. Treating disseminated VF, current drugs are recommended for 4-6 months or longer as needed, often years. We are preparing to test our improved formulation of NikZ in dogs, expecting to see as before some respond to near resolution of disease in 60 days (33% of dogs treated with the traditional formulation), and many to improve in 60 days. Severity scores improved by 50% in 44% of the treated dogs. We expect the improved formulation to be as effective at lower doses, and perhaps more effective, as seen in other VF animal disease tests.

  Collectively, worldwide sales of antifungals across a spectrum of disease organisms exceed $6.3B. Of these used to treat Valley Fever (and other diseases) sales are about $1.9B. The largest seller remains amphotericin B, a 63 year old drug in newer formulations, at about $550M. Comparing NikZ with the best amphotericin B formulations, NikZ has many advantages against Valley Fever. We are confirming how NikZ compares against other important fungal diseases. A first-in-class antifungal can reach peak sales >$1B (fluconoazole, introduced 1988, estimated $175M in 2019)

  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. We could start a pivotal trial within 9 months of support. We anticipate a possible independent showing of human efficacy working with a clinic at the NIH.

  We are seeking $14M to conduct a robust proof of concept trial 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. A milestone Phase I/II trial before the robust trial will cost $4M (part of the $14M), with smaller, earlier milestone increments.

  Our manufacturing is working at a scale sufficient to make clinical trial material. We are refining this for further scalability. We will begin Phase IIa patient enrollment shortly after having human grade trial material, anticipating results 6-9 months later, and with perhaps some early results (endpoint confirmation, some dose ranging).

    We plan to collect approvable data within 18 months of starting a major program, and hope to be commercial about a year later. We look to expand testing in other important fungal diseases known to show sensitivity to NikZ.
    Historical challenges with drug supply capability are mostly resolved. We can supply at trial scale now, and expect to demonstrate capability to supply market requirements to any level about 9 months after starting, in good alignment with human clinical trial plans.

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  April 5, 2024
  "CSG": 68th annual Coccidioidomycosis Study Group
  "Suppressing Coccidioidomycosis in Naturally Infected Dogs by Frequent Dosing of Nikkomycin Z"  – Presentation Deck  

     Oral NikZ treatment gave very high suppression of severe natural valley fever infection in dogs failing available therapies. Testing our new NikZ oral dosing protocol, the dogs felt significantly better in a few days, mostly clearing disease in two months, with essentially undetectable symptoms by four months. This recovery was stable for years after ceasing therapy. One dog with deep CNS symptoms came close to full recovery. Another dog with very early infection, recently diagnosed, responded well and quickly to NikZ.
     Human VF response to standard drugs is highly similar to dog VF response to the same drug, so success in human therapy of VF with NikZ is very, very promising.

  January 10, 2023
  Biotech Showcase

  Nikkomycin Z improved formulation is highly effective against more fungi. Conference Page  
     VFS has been continuing development of Nikkomycin-Z testing in pre-clinical models of our improved dosing formulation, significantly more effective. Recent tests show 100% survival in pre-clinical models of Candida albicans, disseminated Coccidioides infection including in the brain, and when combined with other antifungal drugs effective against Aspergillus fumigatus

  September 28, 2022
  Valley Fever Solutions at White Hat Investor Conference

     We presented news of our continuing advances at the Arizona AzBIO White Hat conference. AzBIO – BioScience Week

  FDA Workshop - August 5, 2020
  Advances and the Promise of Nikkomycin Z

     The US Food and Drug Administration organized a day-long meeting on Valley Fever (coccidioidomycosis), including incidence, history, current therapies, developing therapies, and prospects for the future. FDA Meeting  –  2022 2022 Article
     John Galgiani, MD, discussed the history and promise of NikZ. Galgiani presentation He and Janet Blair, MD, chaired the afternoon session of the meeting, "Session 2: Clinical Trial Considerations for Coccidioidomycosis Treatment."
     As part of a panel discussing industry perspective of drugs in development showing impact on Valley Fever, several speakers spoke of the many challenges in carrying out a trial for a rare disease. Each of these panelists represent a product in development. David Larwood discussed the business challenges facing NikZ in this perspective. Larwood presentation
     The panel highlighted the importance of a drug candidate impacting also a large disease class such as Candida or Aspergillus.
     NikZ has demonstrated clinical benefit against both in pre-clinical testing.