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

孤儿药临床2期临床结果临床1期免疫疗法

2024-05-30

·PRNewswire

SFA Therapeutics Announces Completion of Enrollment in Phase 1b Trial of SFA-002 for Psoriasis

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.

临床1期临床2期孤儿药临床结果

2023-01-06

·PRNewswire

SFA Therapeutics Announces FDA Clearance of IND Application for SFA-001N for the Treatment of NASH and Fibrosis

JENKINTOWN, Pa., Jan. 4, 2023 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing new, microbiome-based therapeutics for the treatment of inflammatory diseases, today announced that it has 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 non-alcoholic steatohepatitis (NASH) with or without fibrosis. SFA-001N is designed to act on multiple pathways involved in the pathogenesis of NASH. NASH is characterized by accumulation of fat, inflammation, liver cell injury and different degrees of scarring (fibrosis). The condition, which affects between 1.5-6.5% of adults in the U.S., can progress to cirrhosis (liver failure) or liver cancer and is projected to become the leading cause of liver transplantation by 2030. There are currently no FDA-approved therapies for NASH, and investigational therapies targeting specific pathways have had limited success. By acting on multiple molecular pathways simultaneously, SFA-001N has the unique potential to address the inflammatory and fibrotic responses associated with NASH. "This IND clearance represents a significant milestone for SFA Therapeutics. By expanding our pipeline to a new therapeutic area, we have the opportunity to demonstrate that our novel microbiome-derived drug development platform has the potential to address a wide range of auto-immune and chronic inflammatory conditions in multiple organs," said Ira Spector, Ph.D., Chief Executive Officer of SFA Therapeutics. "We are grateful to all involved with this regulatory submission and look forward to initiating the study of SFA-001N for NASH and fibrosis patients in Q1 2023." In addition to SFA-001N, SFA Therapeutics is investigating SFA-002 in a Phase 1b clinical trial for psoriasis and expects to complete enrollment in early 2023 and share topline data by the end of 2023. About SFA Therapeutics SFA Therapeutics, Inc. is a clinical stage biopharmaceutical company developing microbiome-based therapeutics for the treatment of inflammatory diseases. The company is developing a platform of safer therapeutics based on breakthrough research of the human microbiome, licensed from Temple University. SFA has identified six small molecule drug candidates from this platform, including its lead asset, SFA-002, which has shown promising Phase 1a results and is currently being investigated in a Phase 1b study for psoriasis. The company's research program is focused on the intersection of chronic inflammation and cancer. Chronic inflammation has been implicated in a wide range of diseases; the SFA pipeline includes targets of psoriasis, hepatocellular carcinoma (the most prevalent form of liver cancer) and NASH, psoriatic arthritis, rheumatoid arthritis, lupus (SLE), inflammatory bowel disease (IBS/IBD), Crohn's disease, and the prevention of relapse/recurrence in AML and CML. SFA Therapeutics is headquartered in Jenkintown, Pa. Please visit www.sfatherapeutics.com to learn more.

临床1期临床申请微生物疗法

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