SFA Therapeutics Announces FDA Approval To Begin IND Trial

SFA Therapeutics, Inc. announced that the US FDA has provided approval to conduct a clinical trial (officially referred to as an IND) for the treatment of “the appearance of the structure of skin with plaques due to psoriasis.”  SFA plans to expand the evaluation of one of its five microbiome-derived drugs, SFA002, in this new trial.

This 30-subject open-label clinical trial in patients with mild-to-moderate psoriasis will enroll 15 patients into treatment with an initial formulation of SFA002 and an additional 15 subjects into treatment with a second formulation.  Treatment duration will be three months, after which patients will be observed for an additional three months.

The Need for an Oral Treatment of Mild to Moderate Psoriasis Remains Acute

“Significant clearing of psoriatic plaques has already been demonstrated with SFA002 in a small study,” commented SFA CEO Dr. Ira Spector, “and, because we know that this patient group has lacked an effective and safe oral treatment option, we are going into this larger IND trial with considerable optimism.”

Study recruitment is planned to begin in the Fall of 2020. Following the trial’s completion, SFA expects to finalize the SFA002 formulation and proceed into a randomized controlled clinical trial.