Biotechnology · Inflammation and autoimmune disease
SFA Therapeutics
A Temple University spinout turning short chain fatty acids from the human gut into oral pills. Its psoriasis candidate has come through a Phase 1b trial the company calls a success, and the registry entry for that trial tells a thinner story than the press releases do.
The lunch table
In 2015 Ira Spector sat down at a social event and worked his way around the table asking people what they did. The man before him was “a professor at Temple University who said he had a drug for liver cancer and couldn’t get anybody interested,” Spector told Technical.ly a decade later.
Spector had spent about 30 years in drug development at Wyeth, Allergan and ICON. He went to look at the data: transgenic mice carrying the hepatitis B oncoprotein HBx, half of which developed no liver tumors at all on the compound while the rest developed only tiny ones.
His answer to Mark Feitelson, as he recalled it for BioBuzz, was blunt. “Show me something that works in humans, and I’ll form a company.”
A year later Feitelson introduced him to Alla Arzumanyan, who had run a small human study of the compound in psoriasis patients outside the United States. Spector took that as the proof he had asked for and left the industry. The company took its name from the founders’ initials and from the molecules at the center of the work: short chain fatty acids, the compounds gut bacteria make when they ferment fiber.
The problem it picked
Psoriasis reaches more than 8 million Americans and about 125 million people worldwide, the National Psoriasis Foundation reports, and most of those cases are not severe. The drugs that transformed severe disease are injected antibodies aimed at one cytokine each. For milder disease the choices thin out fast. Amgen’s Otezla became the first oral therapy approved for plaque psoriasis of all severities only in December 2021.
SFA argues that this is the gap. Mild to moderate patients “represent over 80% of all plaque psoriasis cases,” Spector said in March 2025, and for them “current effective oral treatment options are limited.”
The mechanism is the interesting part. Rather than blocking one cytokine, SFA-002 is presented as an IL-10 up-regulator that raises the body’s main anti-inflammatory signal, expands regulatory T cells and pulls IL-17, IL-23, interferon gamma and TNF down together, without broad immunosuppression. Spector calls the category a fourth generation microbiome company: not fecal transplants, not probiotics, not bacterial colonies, but the metabolites turned into drugs.
The people
Feitelson took his PhD at UCLA, began on hepatitis B at Stanford, was recruited to Fox Chase Cancer Center by Nobel laureate Baruch Blumberg, and moved to Temple as a professor of biology in 2007. Arzumanyan is named by the company as the key inventor of its compounds. James Kirwin, the chief operating officer, is the fourth founder. Robert Dickey IV sits on the board, a detail that surfaces only in the SEC filings of two public companies where he is an officer.
The first money came from Spector and his wife. The first outside check came from Ben Franklin Technology Partners, the Pennsylvania state backed fund. The company went through Y Combinator in the Summer 2021 batch.
Two trials, two stories
The Phase 1a study was six patients. Six of six responded, Spector says, and two responses held after the drug was withdrawn. “What makes this so different is that at least in two cases, we have seen what’s called a durable response, meaning that after treating the patients for a long period of time, we withdrew the drug and the disease did not return,” he told Technical.ly.
The Phase 1b began on March 31, 2022. The company describes it as 30 subjects in two cohorts testing two formulations. Cohort 1 results came out in August 2023: in 14 evaluable subjects, 85% reached PASI 50 and 71% reached PASI 75, with two at PASI 100 and no drug related adverse events. Three months later an extension update put the same cohort at 92% and 72%. In May 2024 the company restated cohort 1 as 92% and 72% without noting that those were the extension numbers.
In August 2026 the board made Chairman Shawn Patrick O’Brien the chief executive, moved Spector to chief strategy officer, and said the Phase 1b was complete. MyChesCo, covering the announcement locally, noted what was missing: “The company characterized results from the Phase 1b study as strong but provided no efficacy data, safety results or statistical measures in its announcement.”
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Phase 1b as registered | NCT05642182. Phase 1, non randomized, open label, masking none. Two experimental arms, both SFA002, one formula with propionate and one without. No placebo arm. Estimated enrollment 90. Started Mar 31, 2022. Sites in Pompano Beach, Fargo and Philadelphia. | Public record |
| Phase 1b as described | 30 subjects in two cohorts of 15; 14 evaluable in cohort 1. The website says 28 participants enrolled and no treatment emergent adverse events in any of them. | Company-stated |
| The placebo comparison | The March 2025 release reports statistically significant PASI and IGA improvements “compared to placebo.” The registered design has no placebo arm, no randomization and no masking. | Differs from registry |
| Registry upkeep | NCT05642182 was last updated Jan 7, 2025 and still reads recruiting. The company said the trial was complete in Aug 2026. | Registry out of date |
| The next trial | NCT06863493, posted Mar 7, 2025: randomized, quadruple masked, 125 participants, SFA002 against Otezla and matched placebo, labeled Phase 2/Phase 3, estimated start Jun 1, 2025. Still not yet recruiting. The website instead describes a 120 patient Phase 2 and lists its identifier as pending registration. | Differs from registry |
| Peer reviewed data | No PubMed indexed paper reports the Phase 1a or Phase 1b results as of Sep 2026. Searches for SFA-002 return nothing. The founders’ indexed output on this science is two reviews and an editorial. | Not found |
| Patents | USPTO records list five granted US patents in this family naming Spector, Feitelson or Arzumanyan: 10,231,941, 11,065,217, 11,759,442, 11,963,938 and 12,622,885. All are assigned to Temple University, which licenses the platform to SFA. | Public record |
| Patent count | Counts given by the company: 7 issued (2022), 9 issued (Jan 2023), 15 (Y Combinator), 15 issued and allowed (Oct 2024), 19 issued (May 2026). The website says 18 granted. | Company-stated |
| Liver programs | Orphan drug designation for SFA-001 in hepatocellular carcinoma in Oct 2019 and an IND clearance for SFA-001N in NASH in Jan 2023, with a study said to be starting that quarter in Philadelphia. Neither program appears on ClinicalTrials.gov. | No registered trial |
Read plainly: SFA has a coherent scientific idea, a decade of work behind it, a real trial that put a real drug into real patients, and a safety record nobody has contradicted. What it does not have is a controlled comparison. Every efficacy number in circulation comes from an open label study with no placebo arm, reported by the sponsor, and none of it has been peer reviewed. The randomized trial that would settle the question has been registered for 18 months and has not started.
What to watch
- Whether NCT06863493 moves off not yet recruiting, and whether it keeps the head to head arm against Otezla.
- A peer reviewed publication of the Phase 1b. Spector said in April 2025 the results were about to be published.
- The Series A. The company was targeting $25 million in April 2025 and has been assembling a syndicate since.
- Any registered trial for SFA-001N in MASH or SFA-009 in pancreatic cancer, both described as near term.
- Whether the registry entries get updated, which is the cheapest credibility a clinical stage company can buy.
In their words
“Show me something that works in humans, and I’ll form a company.”
Ira Spector, co-founder, recalling 2015, BioBuzz, 2024 · Interview
“We call ourselves a fourth-generation microbiome company,”
Ira Spector, PharmaVoice, January 2023 · Interview
“What makes this so different is that at least in two cases, we have seen what’s called a durable response, meaning that after treating the patients for a long period of time, we withdrew the drug and the disease did not return,”
Ira Spector, Technical.ly, March 2025 · Interview
“It is an oral therapeutic, which is critical, because most of our patients with psoriasis end up requiring injectable medicines, and patients in general prefer a pill to a shot,”
Stefan Weiss, MD, MBA, chief medical officer, Dermatology Times, June 2024 · Interview
“SFA-002 is an incredibly safe oral drug with very high efficacy and has the potential to become an important drug in the treatment of psoriasis.”
Daniel Sauder, MD, past chairman of dermatology at Johns Hopkins, in the company’s August 2023 release · Company release
“The company characterized results from the Phase 1b study as strong but provided no efficacy data, safety results or statistical measures in its announcement.”
Timothy Alexander, MyChesCo, August 2026 · Independent
“Raising the funds for phase 2 remains a hurdle, but our data are very strong and should help us overcome this challenge.”
Ira Spector, Pulse 2.0, April 2025 · Interview
Related companies
Sources
- Public recordClinicalTrials.gov NCT05642182
- Public recordClinicalTrials.gov NCT06863493
- Public recordUSPTO grants 10,231,941, 11,065,217, 11,759,442, 11,963,938 and 12,622,885
- Public recordAIM ImmunoTech Inc. proxy naming Robert Dickey IV on the SFA board
- Public recordSEC EDGAR company and full text search for SFA Therapeutics
- IndependentThis pharma startup backed by Y Combinator aims to treat multiple diseases, for good
- IndependentSFA Therapeutics Has Big Vision to Transform Medicine
- IndependentSFA Therapeutics Shifts Leadership as Drug Programs Advance
- IndependentSFA Therapeutics: Interview With CEO Dr. Ira Spector
- CompanySFA Therapeutics Announces Positive Phase 1b Data of SFA-002
- CompanySFA Therapeutics, Inc. Announces Executive Organizational Changes
- CompanySFA Therapeutics website, home and clinical pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
