Accro Bioscience Secures $50M to Advance Novel Colitis Drug AC-101
- $50M Series C Funding: Accro Bioscience secures $50 million to advance its novel colitis drug AC-101.
- $9.7B Market Projection: Global UC therapy market expected to exceed $9.7 billion by 2033.
- Phase IIb Trial: Funding accelerates multi-regional Phase IIb clinical trial for AC-101.
Experts view this funding as a strong validation of Accro Bioscience's innovative approach to treating ulcerative colitis, with AC-101's novel mechanism and oral formulation offering significant potential to address unmet medical needs.
Accro Bioscience Secures $50M to Advance Novel Colitis Drug AC-101
NEW YORK and SUZHOU, China – May 20, 2026 – Accro Bioscience, a clinical-stage biotechnology company, has closed a $50 million Series C financing round to advance its pipeline of novel therapies for immune-mediated diseases. The investment, led by premier healthcare investment firm OrbiMed, provides a significant capital injection to accelerate the development of the company's lead candidate, AC-101, a potential new oral treatment for moderate-to-severe Ulcerative Colitis.
The financing saw participation from a syndicate of prominent global investors, including TCG Crossover (TCGX), LAV, and Cenova Capital, alongside continued support from existing investors Shenzhen Capital Group (SCGC) and Oriza Holdings. The funds are primarily earmarked for a multi-regional Phase IIb clinical trial of AC-101, a drug that represents a new approach to treating the debilitating inflammatory bowel disease.
A Major Vote of Confidence
The successful closing of a substantial Series C round, particularly with a lead investor like OrbiMed, serves as a powerful validation of Accro Bioscience's scientific platform and clinical strategy. OrbiMed, with over $19 billion in assets under management, is a globally recognized leader in healthcare investing, known for identifying companies with the potential to transform medical treatments.
"We are highly impressed by Accro Bioscience's innovative pipeline," said Steven Wang, Ph.D., CFA, a Partner at OrbiMed, in a recent statement. "The team's scientific acumen and track record of strong execution were instrumental in our decision to invest. OrbiMed is excited to partner with Accro to accelerate their global clinical development."
This investment reflects a growing interest in novel mechanisms of action for treating immune-mediated diseases. While the market has effective biologic and small molecule therapies, significant unmet needs remain, creating opportunities for companies with innovative approaches. The participation of firms like TCGX, LAV, and Cenova Capital further underscores the perceived potential of Accro's technology to make a significant impact on a large and growing patient population.
A New Target for Ulcerative Colitis
Ulcerative Colitis (UC) is a chronic inflammatory condition that affects millions worldwide, causing inflammation and ulcers in the colon and rectum. It leads to symptoms like persistent diarrhea, abdominal pain, and rectal bleeding, significantly impacting patients' quality of life. The global market for UC therapies was valued at over $6.5 billion in 2024 and is projected to exceed $9.7 billion by 2033.
While current treatments, including TNF inhibitors and JAK inhibitors, have improved outcomes, a substantial portion of patients either do not respond or lose response over time. Accro's AC-101 aims to address this gap by targeting a different part of the inflammatory cascade.
AC-101 is a selective inhibitor of Receptor-Interacting Protein Kinase 2 (RIPK2). RIPK2 is a crucial enzyme in the NOD signaling pathway, a key component of the body's innate immune system. In diseases like UC, this pathway can become dysregulated, leading to chronic inflammation. By inhibiting RIPK2, AC-101 is designed to block this overactive inflammatory signaling at its source. This mechanism represents a new therapeutic strategy, as no RIPK2-specific inhibitor has yet been approved for any disease, positioning AC-101 as a potential first- or best-in-class therapy.
The Promise of an Oral Therapy
Beyond its novel mechanism, one of the most compelling aspects of AC-101 is its formulation as an oral tablet. Many of the most effective treatments for moderate-to-severe UC are biologics that require intravenous infusions or subcutaneous injections, which can be inconvenient and burdensome for patients managing a chronic condition. The availability of a safe and effective oral therapy is a significant goal in the management of inflammatory bowel disease.
"We at Accro Bioscience are focused on our mission of delivering innovative oral treatments for the millions of patients living with immune mediated diseases," stated Dr. Xiaohu (Jason) Zhang, Co-founder and CEO of Accro Bioscience. This patient-centric approach is a core part of the company's strategy, aiming to improve not only clinical outcomes but also treatment adherence and overall quality of life.
A Disciplined Path to a Pivotal Trial
The new funding will build upon a foundation of promising early-stage clinical data. AC-101 has already completed Phase I studies in healthy volunteers in both Australia and China, where it demonstrated a favorable safety profile and was well-tolerated. These studies also showed that the drug effectively engaged its target, inhibiting the downstream inflammatory cytokines that drive disease.
More recently, Accro completed a Phase Ib/IIa proof-of-concept study in Chinese patients with moderate-to-severe UC, providing the initial evidence of its potential efficacy in the target patient population. These positive results paved the way for a critical regulatory milestone in December 2024, when the company received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA).
The IND clearance allows Accro to proceed with the now-funded Phase IIb study. This multi-regional, randomized, double-blind, placebo-controlled trial will be a rigorous test of AC-101's safety and efficacy in a larger group of UC patients. The successful execution of this trial will be a critical step toward potentially bringing a new class of treatment to patients in need.
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