Avobis Bio Receives FDA Fast Track Designation for AVB-114 Implantable Cell Therapy for Crohn's Perianal Fistulas

– Only implantable cell therapy for Crohn's perianal fistulas with FDA IND clearance and Fast Track designation –

, /PRNewswire/ -- Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the Company's lead therapeutic candidate for Crohn's perianal fistulas.

FDA Fast Track designation is intended to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need. Compelling results from a Mayo Clinic Phase I trial ("STOMP-I") led to the founding of Avobis Bio and primary endpoint results from the Phase II trial ("STOMP-II) of AVB-114 are expected in mid-2025.

"Perianal fistulas are a tremendous challenge for patients and their treating physicians. If the results of the ongoing Phase II trial are consistent with the impact we saw in the Phase I trial, this treatment could transform the lives of Crohn's patients living with perianal fistulas," said William Faubion, Jr., M.D., Dean of Research at Mayo Clinic in Arizona, Medical Director of Mayo Clinic's Center for Regenerative Biotherapeutics, and gastroenterologist who specializes in inflammatory bowel diseases.

The Phase II clinical trial has completed enrollment at 14 US sites and subjects who were randomized to AVB-114 or standard of care are being assessed for combined clinical and radiological remission of the treated fistula. More information on the study (NCT04847739) is available at www.clinicaltrials.gov.

"We are grateful for the FDA's recognition that perianal fistulas are a serious condition for many patients living with Crohn's disease and that AVB-114 has the potential to bring meaningful improvement to their lives," said Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio. "Receiving Fast Track designation will enable us to work closely with FDA in reviewing the STOMP-II primary endpoint results later this year and aligning on the most expeditious commercialization pathway for AVB-114".

About Fast Track Designation

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation may be eligible for more frequent interaction with FDA, rolling submission of marketing application, priority review and accelerated approval.

About Crohn's Perianal Fistulas

Perianal fistulas are painful tunneling wounds connecting the rectum or anus to the skin. The condition is serious as there is uncontrolled fecal drainage, pain and the constant risk of infection or sepsis. An estimated 2 out of 3 patients do not experience durable fistula healing with the current standard of care, resulting in elevated and prolonged suffering due to disease progression and multiple surgeries with complications.

About AVB-114

AVB-114 is an implantable cell therapy which aims to overcome the impaired healing of Crohn's perianal fistulas. Living cells and a plug-shaped bioabsorbable material combine to generate tissue and produce healing signals in a local therapeutic treatment. The Phase I STOMP-I clinical trial demonstrated 76% clinical healing and a ten-fold reduction in annualized exams under anesthesia in patients with persistent refractory perianal Crohn's disease 12 months after treatment. AVB-114 is an investigational drug and limited by United States law to investigational use. Its safety and effectiveness has not been established, and it is not commercially available in any markets.

About Avobis Bio

Avobis Bio's mission is to transform life for patients with debilitating conditions by harnessing the power of implantable biology to develop curative therapies for healing tissues. For more information, please visit avobisbio.com.

Avobis Bio Media Contact:

Tiffany Brown, PhD

Chief Executive Officer

[email protected]

SOURCE Avobis Bio