Inspired by nature, refined by science, optimized for patients.
Locally acting therapies for serious immune-mediated and inflammatory diseases.
Who We Are
Restoring immune balanceat the site of disease.
We are developing differentiated therapies for serious immune-mediated and inflammatory diseases. Azora was founded by two people who refused to accept “good enough” and pursued better ways to treat their own diseases. Launched out of Stanford’s SPARK translational program, AT177 is an investigational oral drug being developed for inflammatory bowel diseases, with an initial focus on ulcerative colitis. AT177 can deliver potent, colon-targeted Aryl-hydrocarbon Receptor (AhR) agonism directly to the site of disease. It’s designed to capture the therapeutic benefits of AhR activation while minimizing systemic exposure.
AT177’s lead indication is in ulcerative colitis (UC), which is a chronic inflammatory disease of the colon and rectum. It arises when the intestinal barrier and immune regulation break down. Symptoms include bloody diarrhea, bowel urgency and abdominal pain. There is no cure for UC, and while treatments exist that aim to induce and then maintain remission, many patients may fail to achieve remission and experience significant side effects.
The unmet need in ulcerative colitis (UC)
Julie Saiki, Ph.D.
Co-founder & UC Patient
Why Azora
For us, this is personal.
We are drug developers building medicines for diseases we know first-hand.
Our co-founder, Julie Saiki, Ph.D., is an ulcerative colitis patient herself. When standard treatments failed her, she took matters in her own hands and found relief with indigo naturalis, a botanical extract that has induced clinical responses and remission in patients with ulcerative colitis. She led the Stanford Phase 1b study of indigo naturalis that provided key clinical evidence that AhR activation could treat ulcerative colitis. While the study validated the biology, it also highlighted the limitations of indigo naturalis as an unrefined botanical with potential safety and consistency challenges.
Our co-founder, Matt Davidson, Ph.D., followed a similar path. Dissatisfied with the lack of a curative treatment for his own viral skin condition, he went to work developing a therapy and advanced it from idea to FDA approval. Azora is what happens when the same people who need a medicine are the ones who know how to build it.
Read more about Julie’s story →The Science
The Aryl Hydrocarbon receptor is a master regulator of gut health.
The Aryl Hydrocarbon receptor (AhR) governs mucosal immunity and epithelial barrier integrity in the gut. Restoring AhR signaling is a clinically validated way to treat inflammatory diseases.
- AT177 is designed with patients in mind. It’s an investigational oral treatment engineered to work locally while limiting systemic exposure, with the goal of moving past the efficacy ceiling and the safety trade-offs of existing therapies.
- Reduced AhR signaling can increase the risk of developing UC. Disrupted AhR activity is associated with ulcerative colitis risk and severity in an open-label study; indigo naturalis restored signaling with a ~12,000× increase in colonic AhR activity.3
- AT177 activates AhR at the site of disease. AT177 liberates indirubin, the potent AhR agonist derived the botanical indigo naturalis, and acts in the lumen of the colon. Indirubin directly binds the AhR.
- AT177 drives system-level regulation. By coordinating hundreds of genes involved in immune regulation and epithelial health, AhR activation has the potential to engage a broader spectrum of disease biology than single target therapies.
Scientific Publications
We pioneered the science that helped establish AhR in ulcerative colitis.
The clinical case was built with indigo naturalis, the botanical that inspired AT177.
Treatment-refractory ulcerative colitis responsive to indigo naturalis
Saiki J, Andreasson J, et al.BMJ Open Gastroenterology · 2021 Randomized · Placebo controlled · n=86Efficacy of indigo naturalis in a multicenter randomized controlled trial of patients with ulcerative colitis
Naganuma M, et al.Gastroenterology · 2018 · 154(4):935–947 1-year maintenanceOne-year clinical efficacy and safety of indigo naturalis for active ulcerative colitis: a real-world prospective study
Matsuno et al.Intestinal Research · 2022 · 20(2):260–268Pipeline
A focused pipeline built on validated biology.
Azora is advancing AT177, a fully-synthetic, patented, oral colon-targeted AhR agonist, through IND-enabling studies toward clinical proof of concept in ulcerative colitis, with expansion potential in Crohn’s disease.
Leadership
An experienced team with a track record of FDA approvals.
Connect
Let’s advance the science together.
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