Cibus Therapeutics and Greenstone Biosciences Announce First Participant Dosed in Phase 1 Trial of CBT-248 (GSB-D248), an Investigational Oral Anti-Inflammatory Therapy for Chronic Pancreatitis

Cibus Therapeutics and Greenstone Biosciences today announced that the first participant has been dosed in a Phase 1 clinical trial of CBT-248 (GSB-D248), an investigational oral small-molecule therapy being developed for chronic pancreatitis and ulcerative colitis. The trial is being conducted in Australia.

CBT-248 was developed at Greenstone Biosciences and is exclusively licensed to Cibus Therapeutics, which is leading its clinical development. The compound is designed to modulate multiple inflammatory pathways, with preclinical studies demonstrating efficacy in models of chronic pancreatitis and ulcerative colitis.

Chronic pancreatitis is a progressive fibro-inflammatory disease of the pancreas that causes severe, often intractable pain, irreversible tissue damage, and loss of digestive and endocrine function. It is estimated to affect approximately 3 million people worldwide and is associated with an increased risk of pancreatic cancer. No approved disease-modifying therapy exists; current care is limited to managing symptoms and complications.

Ulcerative colitis is a chronic inflammatory bowel disease characterized by persistent inflammation and ulceration of the colon, causing symptoms such as abdominal pain, bloody diarrhea, urgency, and fatigue. Despite advances in treatment, many patients experience inadequate responses, loss of efficacy, or intolerance to existing therapies, highlighting the continued need for safer and more effective treatments that provide sustained disease control.

The Phase 1 study is a randomized, double-blind, placebo-controlled, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics of CBT-248 in healthy adult volunteers. The study plans to enroll 32 participants across four dose cohorts at Nucleus Network in Melbourne, Australia, and includes an assessment of the effect of food on drug exposure. Additional details are available on ClinicalTrials.gov (NCT07905053) and ANZCTR (ACTRN12626001257358). 

Data from the trial are intended to inform dose selection and the design of subsequent clinical studies in patients with chronic pancreatitis and ulcerative colitis. Cibus expects topline safety, tolerability and PK data in Q2 2027.

"Taking GSB-D248 from discovery through IND-enabling studies meant answering one question at every step: will what we see in the lab hold up in people?" said Mukhtar Ahmed, PhD, Director of Project & Portfolio Strategy at Greenstone Biosciences, who led the compound's preclinical development. "Seeing the first participant dosed is the start of getting that answer. Our team is proud to have handed Cibus a program built to make that transition, and we will keep supporting it as it moves toward patients."

“Dosing the first participant marks an important milestone in advancing CBT-248 from preclinical research into clinical development,” said Honit Piplani, PhD, Director of Translational and Clinical Science at Cibus Therapeutics. “People living with chronic pancreatitis face persistent pain, difficulty eating and uncertainty about their future, and there is no approved therapy that targets the underlying disease. This first study will establish the safety, tolerability and pharmacokinetics we need to design studies in patients, and we are grateful to our partners at Greenstone Biosciences for helping us reach this point.”

"This milestone reflects the discovery and translational work our team put into CBT-248 (GSB-D248)," said Joseph Wu, MD, PhD, Co-founder of Greenstone Biosciences and a Professor of Medicine & Radiology at Stanford University. "We built the preclinical package on human-relevant models to give the program the strongest possible footing for the clinic. We delivered on the plan we set with Cibus, and we look forward to supporting the program as it advances toward patients."