SFA-002

JENKINTOWN, Pa., Oct. 22, 2024 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the expansion of its intellectual property in autoimmune disease and hepatocellular carcinoma. SFA Therapeutics has been issued a new patent in the United States (11963938) and has been allowed two patent applications in Canada (2,974,510) and in Korea (10-2017-7023391) with patent coverage through 2036. SFA Therapeutics has also been issued one new patent in Korea (10-2646764) with patent coverage through 2038. The United States patent and the allowed Canadian and Korean patent applications protect the short chain fatty acid composition that comprises SFA's proprietary oral small-molecule biosynthetic compound SFA-001. SFA-001 is a potent immunomodulator being evaluated for the prevention, delay of onset, and treatment of hepatocellular carcinoma. In preclinical studies, SFA-001 demonstrated cytotoxicity against two common human liver cancer cell lines expressing the hepatitis B oncoprotein, HBx. Huh7x and Hep3BX are highly sensitive to SFA-001 without damage to normal liver cells. In 2019, the United States Food and Drug Administration granted an Orphan Drug Designation (ODD) to SFA-001 for the treatment of hepatocellular carcinoma. The Korean patent protects the short chain fatty acid composition that comprises SFA-002, SFA Therapeutics' lead candidate and Phase-2 ready potent immunomodulator being evaluated for the treatment of psoriasis. SFA-002 acts on multiple therapeutic pathways with the aim of restoring balance to the immune system. While SFA-002 inhibits pathways of pro-inflammatory cytokines such as IL-17, IL-23, TNF-α, and IFN-y, it also increases Treg differentiation and upregulates the anti-inflammatory cytokine IL-10. "As SFA's clinical development progresses, we understand the importance of strengthening our intellectual property portfolio to protect SFA Therapeutics' proprietary therapeutic candidates," said Dr. Ira Spector, Chief Executive Officer of SFA Therapeutics. "The expansion of our patent portfolio allows us to continue the research and development necessary to bring drug candidates like SFA-001 and SFA-002 through the clinic to patients of autoimmune and inflammatory diseases. This brings the total number of issued and allowed SFA Therapeutics patents to 15, with 33 additional patents pending." "These patents demonstrate the novel nature of SFA Therapeutics' platform and drug candidates which are developed by adding disease-specific adjuvants to compounds that are naturally found in the human body," said Dr. Mark Feitelson, Chief Scientific Officer of SFA Therapeutics. "Our therapeutic candidates target multiple pathways in autoimmune and inflammatory conditions, working to inhibit pro-inflammatory cytokines, up-regulate anti-inflammatory targets, and suppress autoimmunity. We believe the intellectual property protected by these patents has the potential to not only manage symptoms from diseases, but to also address the underlying cause of these conditions and prevent or delay their onset." About SFA Therapeutics SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, a potent immunomodulator, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis. SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer. SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit to learn more. Company Contact Ira Spector, Ph.D. SFA Therapeutics, Inc. +1 267-584-1080 Media Contacts Tony Russo, Ph.D. Russo Partners, LLC [email protected] Maddie Stabinski Russo Partners, LLC [email protected] SOURCE SFA Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

JENKINTOWN, Pa., May 30, 2024 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the completion of enrollment of 15 patients in cohort 2 of its Phase 1b clinical trial of SFA-002 for the treatment of mild-to-moderate chronic plaque psoriasis. "This clinical milestone is essential to our ongoing evaluation of the safety and efficacy of SFA-002 for the treatment of psoriasis. As an endogenous biosynthetic compound, SFA-002 has the potential to be a disease-modifying therapeutic that targets multiple pathways with greater efficacy and less side effects for patients," stated Dr. Stefan Weiss, Chief Medical Officer of SFA Therapeutics. "As we approach the conclusion of our Phase 1b trial, we look forward to entering Phase 2 studies in the second half of the year," stated Ira Spector, Chief Executive Officer of SFA Therapeutics. "The encouraging topline and safety results from cohort 1 of the Phase 1b clinical trial demonstrate the promise of SFA-002 to be a successful treatment for psoriasis. We anticipate additional Phase 1b data readouts from cohort 1 along with topline data from cohort 2 in the coming months." SFA Therapeutics previously reported positive topline efficacy and safety results from cohort 1 of its Phase 1b clinical trial of SFA-002. In 14 evaluable subjects with difficult-to-treat scalp psoriasis and palmoplantar psoriasis, including six subjects on the three-month extension, 92% of patients demonstrated a PASI improvement of greater than 50. 72% of subjects showed an improvement of greater than PASI 75. Two subjects achieved PASI 100 (100% clearance). No related adverse events or toxicities were observed during the treatment period and follow-up, with no rebound effects observed. About SFA Therapeutics SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis. SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer. SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit to learn more. Company Contact Ira Spector, Ph.D. SFA Therapeutics, Inc. +1 267-584-1080 Media Contacts Tony Russo, Ph.D. Russo Partners, LLC [email protected] Maddie Stabinski Russo Partners, LLC [email protected] SOURCE SFA Therapeutics, Inc.