SFA Therapeutics Announces FDA Clearance for Amendment to Extend Phase 1b Trial of SFA-002 for Psoriasis

11 Jan 2023
Phase 1Microbial therapyIND
JENKINTOWN, Pa., Jan. 11, 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 from the U.S. Food and Drug Administration (FDA) to proceed with an extension to the ongoing Phase 1b clinical trial of SFA-002, an investigational drug candidate for psoriasis. The extension will allow responders to remain on SFA-002 treatment for an additional three month period.
"We are grateful for this opportunity to gain additional patient experience with SFA-002 in our Phase 1b clinical study," said James Kirwin, MBA, Chief Operating Officer and Head of Clinical Operations at SFA Therapeutics. "By allowing responders to remain on treatment for an extended period, we will gain invaluable, longer-term exposure data on SFA-002 to inform future clinical development and regulatory strategies."
"SFA-002 has the unique opportunity to become a groundbreaking treatment option for patients with psoriasis," said Alla Arzumanyan, Ph.D., Chief Development Officer and Co-Founder at SFA Therapeutics and Assistant Professor at Temple University. "Unlike existing therapies, which typically act on a single target and can be associated with serious side effects, SFA-002 is a potential multi-target and disease-modifying therapeutic that has already demonstrated efficacy, safety and durability in preliminary Phase 1a studies. We look forward to the continued development of SFA-002 and the advancement of our novel microbiome-derived platform to support patients in need."
SFA Therapeutics expects to complete Phase 1b trial enrollment in early 2023 and to share topline data by the end of 2023. The company's Chief Executive Officer, Ira Spector, Ph.D., will present a corporate update at the Biotech Showcase in San Francisco, Calif. today, Jan. 11, at 10:45 a.m. Pacific Time.
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.
Ira Spector, Ph.D.
+1 267-584-1080
For Media Inquiries:
David Melamed, Ph.D.
Russo Partners, LLC
[email protected]
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