FibroBiologics Announces Preliminary Proof of Concept for Fibroblast-Based Diabetes Treatment

2024-03-19 22:27:29

HOUSTON, March 19, 2024 /PRNewswire/ — FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with more than 150 issued and pending patents focused on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the progress of a clinical program in development using a fibroblast-based pancreatic beta-cell spheroid grown in vitro Insulin secreted upon glucose stimulation. The development and reproducibility of this work shows that an organoid composed of fibroblasts, beta cells and other components can successfully and permanently secrete insulin.

“This early proof of concept is encouraging and may lead to a new and durable potential allogeneic treatment option for people with insulin-dependent diabetes,” said Hamid Khoja, Ph.D., Chief Scientific Officer. “We look forward to confirming these early results in vivo “We will then decide whether to designate the program as an early-stage preclinical project for the development of a minimally invasive therapeutic for type 1 diabetes.”

Information regarding diabetes

Diabetes mellitus is a chronic, heterogeneous metabolic disease characterized by elevated blood glucose levels due to defects in insulin production or action, affecting more than 37 million people in the United States and over 500 million people worldwide. Type 1 diabetes, an autoimmune disease in which the immune system destroys the pancreatic beta cells that produce insulin, accounts for 10% of diabetes cases worldwide, while type 2 diabetes, in which the body does not respond to insulin, accounts for the remaining 90 % of diabetes cases. Given the high and increasing prevalence of the disease, more than 200 million people are dependent on consistent and often daily insulin therapy for their health. To date, there are no permanent, long-term and economical treatment options.

Cautionary Notes Regarding Forward-Looking Statements

This communication contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information regarding the potential of organoids composed of fibroblasts, beta cells and other components to successfully and persistently secrete insulin and treat insulin-dependent diabetes and our expectations regarding plans for our current and future product candidates and programs. These forward-looking statements are based on the current expectations, estimates, forecasts and beliefs of the management of FibroBiologics and on a number of assumptions regarding future events. If in this release the words “estimates”, “projects”, “expects”, “anticipates”, “forecasts”, “plans”, “intends”, “believes”, “seeks”, “may”, “will”, “should” , “future”, “suggest” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of FibroBiologics’ management and which might cause the actual results may differ materially from those reflected in the forward-looking statements, including those discussed under the heading “Risk Factors” and elsewhere in FibroBiologics’ annual, quarterly and current reports (ie, Form 10-K, Form 10- Q and Form 8-K) filed or furnished with the SEC and any subsequent public reports, copies of which are available on the SEC’s website atwww.sec.gov available. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) FibroBiologics’ ability to continue to meet Nasdaq listing requirements; (b) risks related to FibroBiologics’ liquidity and its ability to maintain sufficient capital resources to conduct its business; (c) the ability to manage the business effectively as a result of the super voting power granted to the board of directors; (d) the expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; and (e) the unpredictable relationship between R&D and preclinical results and clinical trial results. Forward-looking statements speak only as of the date on which they are made. Readers are cautioned not to place undue reliance on forward-looking statements and FibroBiologics assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information or in the future, except as required by law events or for other reasons. FibroBiologics gives no assurance that it will achieve its expectations.

Information regarding FibroBiologics

Houston-based FibroBiologics is a cell therapy and regenerative medicine company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics has more than 150 U.S. and international patents/patent applications in various clinical areas, including disc degeneration, orthopedics, multiple sclerosis, wound healing, organ regression reversal and cancer. FibroBiologics represents the next generation of medical advances in cell therapy. For more information, seewww.FibroBiologics.com.

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