Newark, Del., October 3, 2025 – Avobis Bio LLC, a clinical-stage biotechnology company focused on implantable cell therapies, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AVB-114, the company’s lead therapeutic candidate for Crohn’s perianal fistulas. This designation complements its existing Fast Track status and offers benefits such as intensive FDA guidance, senior management support, and flexible clinical trial design, aiming to expedite the development of this therapy for a serious unmet medical need.
Science SignificanceAVB-114
AVB-114 is a pioneering implantable cell therapy designed to promote healing in patients with Crohn’s perianal fistulas, a condition where persistent tunneling wounds cause pain, uncontrolled fecal drainage, and high infection risk. Phase I STOMP-I clinical trial data demonstrated 76% drainage cessation 12 months post-treatment, establishing early clinical evidence of efficacy. The recently completed primary analysis of the phase II STOMP-II randomized multicenter trial further validates AVB-114’s potential. Results will be presented at the American College of Gastroenterology 2025 Annual Scientific Meeting, highlighting the therapy’s innovative mechanism combining living cells with a bioabsorbable plug to stimulate tissue repair.
Regulatory Significance
RMAT designation facilitates expedited development and review for regenerative medicine therapies showing preliminary clinical evidence of addressing serious conditions. Benefits include early, frequent, and prioritized interactions with the FDA, use of surrogate or intermediate trial endpoints, and potential eligibility for accelerated approval. This status positions Avobis Bio to collaborate closely with regulators on the design and execution of a phase III pivotal trial for AVB-114.
Business Significance
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The RMAT designation represents a major milestone for Avobis Bio, strengthening investor confidence and supporting ongoing fundraising initiatives. The recognition of AVB-114’s potential by the FDA underscores the company’s leadership in implantable regenerative therapies. By advancing toward phase III studies, Avobis Bio positions itself competitively in the high-value therapeutic area of rare Crohn’s complications, where treatment options are limited.
Patients’ Significance
Perianal fistulas in Crohn’s disease are challenging to treat, with two-thirds of patients failing to achieve durable healing using current standards of care. AVB-114’s innovative design aims to deliver localized tissue regeneration and healing signals, offering patients a potential curative approach. RMAT designation accelerates the path to pivotal trials and, ultimately, patient access to this therapy, potentially reducing pain, infection risk, and repeated surgeries.
Policy Significance
The FDA’s RMAT program exemplifies policy frameworks designed to expedite development of therapies for serious or life-threatening conditions. AVB-114’s designation reinforces the importance of regulatory pathways in supporting innovation, streamlining patient access to novel regenerative medicines, and fostering industry investment in areas of high unmet need.
Transaction Highlights
Avobis Bio’s AVB-114 has received RMAT designation from the FDA, building on its existing Fast Track status. This regulatory recognition provides enhanced guidance from senior FDA management, opportunities for early and frequent interactions, and flexibility in clinical trial design, all aimed at accelerating development for Crohn’s perianal fistulas—a serious condition with high unmet medical need. The recent primary analysis of the phase II STOMP-II trial represents a key milestone, demonstrating the therapy’s clinical potential and supporting phase III trial planning. These developments strengthen Avobis Bio’s pipeline credibility, support ongoing fundraising initiatives, and underscore the company’s leadership in implantable regenerative medicine, positioning AVB-114 as a promising therapeutic candidate in a challenging patient population.
Source: Avobis Bio Press Release
