A New Paradigm in Drug Development
A completely new approach to drug discovery and development
Our pipeline includes treatments for Psoriasis, Liver Cancer (Hepatitis B, NASH and HCC), Ophthalmic Diseases, Cytokine Release Syndrome- a side effect in CAR-T, and other diseases.
Our microbiome-derived drugs are derived from natural substances, and enable a new platform for developing treatments which have the potential to treat over 85 chronic inflammatory diseases currently afflicting patients; providing safer treatments than current therapies.
Our first drug is an oral treatment for psoriasis
• Oral drug (tablet or capsule)
• Extended release
• Twice per day dosing (potential for once daily)
• Low side-effect profile; not an MAB, no antibodies
• Low cost of goods
• Can be combined with marketed drugs to lower side effects and increase overall efficacy
Summary of the Psoriasis Market Landscape
• Current treatments are expensive
• Follow-up healthcare burden, testing and follow-up cost is high
• Co-morbidity is high (potential to treat with the same SFA drug)
• Efficacy is not always sustained; patients often need to switch therapies
• Patient, prescriber and payer satisfaction is low
• “Patients are afraid to try current treatments”- the market is underserved
SFA’s drug addresses major unmet needs in the psoriasis market
In a small case-controlled human trial, a Proof of Activity treatment effect was observed.
A Phase 2A Proof of Concept trial is planned for 2018-2019.
Our second drug candidate is focused on Hepatitis B, NASH and Hepatocellular Carcinoma
In-vitro data demonstrated a significant reduction in both the number of hepatocellular carcinoma tumors and in tumor sizes, in HBX mice.
CEO: Dr. Ira Spector Experienced drug developer at Wyeth, Pfizer, Allergan & ICON, has been involved with 33 NDAs & 12 medical devices. Co-founder of 3 startups. PhD, University of Medicine & Dentistry, NJ, MBA, Drexel University, B.S. Physics, B.S. E.E., Washington University, St. Louis.
CSO: Dr. Mark Feitelson Co-inventor; Professor at Temple University, expert in hepatitis and liver cancer; prior research at Jefferson Fox Chase & Stanford University. PhD, David Geffen School of Medicine at UCLA, B.S. Biology, University of California, Irvine.
CDO: Dr. Alla Arzumanyan Co-inventor; Assistant Professor at Temple University, formerly at Jefferson University; expert in hepatitis B & GI microbiome metabolites. PhD, Yerevan State University, Armenia.
• Dr. Chris Gallen, MD, PhD, CEO, WEX Pharmaceuticals
• David Kunin, ex-FDA, regulatory affairs advisor
• Sandra Stoneman, Duane Morris, corporate counsel
• Todd Wallach, CEO, Evogen, business advisor
• K&L Gates and Riverside Law, IP Counsel
• External advisors in finance, ophthalmology, dermatology,
clinical trial design and rheumatology
Five provisional patents filed:
1. Cancer Prevention in Liver Disease
2. Treatment of Psoriasis and Associated Skin Diseases
3. Combination Therapy in Psoriasis/Skin Diseases
4. Oral Drug for the Treatment of Uveitis
5. Prevention of AutoImmune Diseases in C-Section
Five additional patents planned by the end of 2017
Composition of Matter Patent filed.