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About Us

SFA Therapeutics, Inc. 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

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 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

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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

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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

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Lead compound SFA002 has FDA approval to enter into Phase 2 (IND pending)

SFA002 in Moderate-Severe Psoriasis

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Before and after oral treatment for 30 days.         

Subject after photo at 4 months.

SFA002 in Severe Psoriasis

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Subject on treatment for 5 years

Current Focus

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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 1b clinical trial is planned to start before the end of 2019. This is a formulation optimization trial.


A Phase 2A Proof of Concept trial is planned for 2021.  


Our second drug candidate is focused on Hepatitis B, NASH and Hepatocellular Carcinoma (US Patents  10,143,669 B2  and 10,231,641 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.


VP, Regulatory Affairs:  Dr. King Lee  Pharmaceutical development veteran with 50 clinical and nonclinical studies (toxicology, pharmacology and ADME studies), over 50 study reports for IND/NDA and regulatory submission. Composed 20 INDs/CTAs, 5 pre-NDAs, and 2 NDAs. PhD, University of Kentucky, Pharmacology, post-doc Physiology, certification in Regulatory Affairs.

 

Current Scientific and Business Advisors:


•  Dr. Chris Gallen, MD, PhD, CEO, WEX Pharmaceuticals

 Mr. James Kirwin, MBA, Clinical Operations Adviser

•  Dr. Jerry Draper, PhD, VP CMC

•  Ms. Sandra Stoneman, Duane Morris, Corporate Counsel

•  Mr. Jordan Warshafsky, Ashton Tweed

 Mr. Donald Fishbein, In-Focus Capital, Commercial Development Adviser

•  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 Adviser

•  Dr. Gerald Fischer, Toxicology Scientific Adviser

•  Dr. Angela Lynch, ToxPlus, pre-clinical development

•  External advisers accessible in research, finance, ophthalmology, dermatology, clinical trial design, biostatistics, and rheumatology 

•  Deep network based on 25+ years of contacts and relationships  



Intellectual Property

Two patents issued, seven patents filed: 


1.  Cancer Prevention in Liver Disease (US Patent 10,143,669 B2)

2.  Cancer Prevention and Treatment of Liver Disease (US Patent 10,231,941 B2)

3.  Treatment of Psoriasis and Associated Skin Diseases

4.  Combination Therapy in Psoriasis/Skin Diseases

5.  Oral Drug for the Treatment of Uveitis

6.  Prevention of AutoImmune Diseases in C-Section Neonates 

7.  Adjuvant to Immunotherapy (CAR-T Cytokine Release Syndrome)   

8.  Prevention of Relapse/ Recurrence in Leukemias

9. Omnibus patent for over 10 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


FDA Orphan Drug Designation granted 22 October 2019

 

 https://www.prlog.org/12795527-sfa-therapeutics-inc-receives-an-fda-orphan-drug-designation-odd-for-sfa001-in-the-treatment-of-hepatocellular-carcinoma-hcc.pdf 


Recent Presentations on YouTube:

https://youtu.be/bEy1oJwg5Ps

https://youtu.be/yZz3c8gqjBg


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

https://www.ashtontweed.com/ceo-leadership-series-ira-c-spector-ph-d-ceo-sfa-therapeutics/?utm_source=All+Database+Contacts&utm_campaign=ce0a7711f6-EMAIL_CAMPAIGN_2018_01_22&utm_medium=email&utm_term=0_7e248c9e79-ce0a7711f6-139627405


SFA Therapeutics Selected as a 2018 Stellar Startup by Philadelphia Inquirer


SFA Therapeutics Selected as a 2019 Finalist in the LyfeBulb-Helsinn Oncology Summit

https://www.linkedin.com/feed/update/urn:li:activity:6514092214677749761/


SFA Therapeutics developing its psoriasis therapy to showcase its anti-inflammatory platform 

https://www.youtube.com/watch?v=joNFT2GKA6o


SFA Therapeutics Selected to the NYU Stern School of Business 2019-2020 Life Sciences Endless Frontier Labs Accelerator


SFA is pleased to participate as a startup in Endless Frontier Labs. Endless Frontier Labs is a nine-month program at NYU's Stern Business School focused on transforming breakthrough science into high-growth businesses.  Startup founders work with groups of mentors comprised of venture capitalists, angel investors, entrepreneurs, scientists, and MBA consultants to maximize the potential of their company’s success.   https://endlessfrontierlabs.com/ 


SFA Therapeutics Selected as a Deep Tech Pioneer by Hello Tomorrow


Among over 5,000 applicants from 128 different countries, we have been selected as one of @hellotmrc’s Deep Tech Pioneers! ➡️https://hello-tomorrow.org/summit/     #DeepTechPioneer #HTSummit 



US Federal Contractor Verified

Contact Us

For more information

Dr. Ira C. Spector, CEO

 

SFA Therapeutics

610 Old York Rd, Suite 400, Jenkintown, Pennsylvania 19046, United States

267-584-1080

 

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