About Us
SFA Therapeutics, LLC is a development-stage bio-pharmaceutical startup company focused on a new advancement in the treatment of chronic inflammatory disease-- the use of microbiome-derived metabolites as drugs
A completely new approach to drug discovery and development
Deriving drugs from bacterial metabolites found in man means no genotoxicity, faster clinical development and safer treatments
Our pipeline includes treatments for Psoriasis, Liver Cancer (Hepatitis B, NASH and HCC), Ophthalmic Diseases, Cytokine Release Syndrome- a side effect in CAR-T, Prevention of Relapse/Recurrence in Leukemias, and other diseases.
Safer, Faster to Market and Lower R&D Cost
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 proprietary discovery process matches metabolites and adjuvants to treat specific indications caused by chronic inflammation. This approach results in much faster drug development and much faster clinical development, with higher probabilities for success.
SFA Therapeutics Pipeline
SFA has five formulations under development
Lead compound SFA002 has FDA approval to enter into Phase 2 (IND pending)
SFA002 in Moderate-Severe Psoriasis
Before and after oral treatment for 30 days.
Subject after photo at 4 months.
SFA002 in Severe Psoriasis
Subject on treatment for 4 years
Current Focus
Pipeline
Our first drug is an oral treatment for psoriasis
Target Product Profile
• Oral drug (capsule)
• Enteric-coated
• 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
Data:
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 (US Patent 10,143,669 B2)
Data:
In-vitro data demonstrated a significant reduction in both the number of hepatocellular carcinoma tumors and in tumor sizes, in HBX mice.
Core Team
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.
Current Scientific and Business Advisors:
• Dr. Chris Gallen, MD, PhD, CEO, WEX Pharmaceuticals
• Mr. David Kunin, ex-FDA, Regulatory Affairs Advisor
• Dr. Jerry Draper, PhD, VP CMC
• Mr. Charles Bernhardt, CFO
• Ms. Sandra Stoneman, Duane Morris, Corporate Counsel
• Mr. Jordan Warshafsky, Ashton Tweed
• Mr. Donald Fishbein, Evolve Therapeutics, Commercial Development Advisor
• Dr. Nguyen Quang, Riverside Law, IP Attorney
• Dr. Michelle Glasky-Bergman and Mr. Louis Cullen, K&L Gates, IP Counsel
• Dr. Roger Porter, Pharmacology Scientific Advisor
• Dr. Gerald Fischer, Toxicology Scientific Advisor
• Dr. Angela Lynch, ToxPlus, pre-clinical development
• External advisors accessible in research, finance, ophthalmology, dermatology, clinical trial design, biostatistics, and rheumatology
• Deep network based on 25+ years of contacts and relationships
Intellectual Property
One patent issued, seven provisional patents filed:
1. Cancer Prevention in Liver Disease (US Patent 10,143,669 B2)
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 Neonates
6. Adjuvant to Immunotherapy (CAR-T Cytokine Release Syndrome)
7. Prevention of Relapse/ Recurrence in Leukemias
8. Omnibus patent for over 60 chronic inflammatory indications
- Composition of Matter patents filed
- Global patents filed
- USPTO Accelerated action
- FDA Preclinical Development Review Completed- currently preparing IND for Phase 2A clinical trial
Recent Presentation on YouTube:
https://www.youtube.com/watch?v=OX9FRXBMGNE&feature=youtu.be
Recent Broadcast Interview- SFA Therapeutics on Money-Matters TV:
https://www.youtube.com/watch?v=1_DGcgPw-GU&sns=em
New Article About SFA Therapeutics and It's Founder
SFA Therapeutics Selected as a 2018 Stellar Startup by Philadelphia Inquirer
http://www.philly.com/philly/gallery/stellar-startups-2018-finalists.html?photo_
