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

Rhea-AI Summary

FibroBiologics, Inc. (Nasdaq: FBLG) announces progress in developing a fibroblast-based pancreatic beta cell spheroid that secretes insulin, potentially offering a new treatment for insulin-dependent diabetes. The company's clinical program shows promising early results, aiming to develop a minimally invasive therapeutic for type 1 diabetes.

Biotech Industry Analyst

The announcement by FibroBiologics represents a significant advancement in the field of regenerative medicine, potentially disrupting the current treatment landscape for insulin-dependent diabetes. The company's work on fibroblast-based pancreatic beta cell spheroids is a novel approach, diverging from traditional insulin therapy and islet cell transplantation. The ability to generate organoids that can secrete insulin in response to glucose levels in vitro is a promising step towards a functional cure for diabetes, which could reduce the need for daily insulin injections and improve patient quality of life.

From an investment perspective, the progress of this clinical program could have substantial implications for FibroBiologics' valuation, considering the large market of diabetes patients seeking better treatment options. However, it's important to note that the program is still in its early stages and there will be significant scientific and regulatory hurdles to overcome before this therapy could reach the market. Investors should monitor the company's future announcements for in vivo results and potential designation as a pre-clinical project, which would be critical milestones indicating the feasibility and commercial potential of the treatment.

Medical Research Analyst

The utilization of fibroblast-derived organoids in diabetes treatment is a testament to the innovative approaches being explored in medical research. FibroBiologics' progress indicates a successful in vitro response, which is a foundational step in organoid technology. However, the transition from in vitro to in vivo application is a complex process that involves ensuring the safety, efficacy and durability of the treatment in a living organism. The reproducibility of the organoids' insulin secretion in a controlled environment is promising, yet the real test will be their performance in the human body.

For stakeholders, the potential benefits of a successful treatment include not just improved patient outcomes but also the opening of a new therapeutic category that could capture significant market share. Long-term, if the therapy proves effective and safe, it could lead to a reduction in healthcare costs associated with diabetes management. On the flip side, the development of such therapies requires substantial investment and there's always the risk of failure during clinical development, which could impact the company's financial stability and stock performance.

HOUSTON, March 19, 2024 /PRNewswire/ -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the progress of a clinical program under development using a fibroblast-based pancreatic beta cell spheroid that secretes insulin in vitro upon glucose stimulation. The development and reproducibility of this work demonstrates that an organoid composed of fibroblasts, beta cells and other components can successfully and durably 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 and in vivo utility. We will then determine whether to designate the program as an early phase pre-clinical project for developing a minimally invasive therapeutic for type 1 diabetes."

About Diabetes

Diabetes mellitus is a chronic heterogeneous metabolic disease characterized by elevated blood glucose levels due to abnormalities in either insulin production or insulin action that impacts more than 37 million people in the United States and over 500 million people worldwide. Type 1 diabetes, an autoimmune disorder in which the immune system destroys the pancreatic beta cells that produce insulin, accounts for 10% of diabetes cases worldwide, and type 2 diabetes, in which the body does not respond to insulin, accounts for the remaining 90% of diabetes cases. With such a high and growing prevalence of the disease, over 200 million individuals are dependent on consistent and often daily insulin therapy for their health. To date, durable, long-term, and economical treatment options are not available.

Cautionary Statement 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 concerning the potential of organoids composed of fibroblasts, beta cells and other components to successfully and durably secrete insulin and to 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 FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" 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 outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) the ability of FibroBiologics to continue to meet Nasdaq listing requirements; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) the ability to effectively manage the business as a result of the super-voting proxy given to the Board of Directors; (d) 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 study results. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.  

About FibroBiologics 

Based in Houston, 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 holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit www.FibroBiologics.com. 

Investor Relations: 
Nic Johnson or Harrison Seidner, Ph.D. 
Russo Partners 
(646) 942-5599 
fibrobiologicsIR@russopr.com 

Media Contact: 
Liz Phillips 
Russo Partners 
(347) 956-7697 
Elizabeth.phillips@russopartnersllc.com 

General Inquiries: 
info@fibrobiologics.com

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SOURCE FibroBiologics

FAQ

What is the focus of FibroBiologics, Inc. (FBLG)?

FibroBiologics is a clinical-stage biotechnology company focusing on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials.

What progress has FibroBiologics made in their clinical program?

FibroBiologics has announced progress in developing a fibroblast-based pancreatic beta cell spheroid that secretes insulin upon glucose stimulation, showing promising early results.

What is the potential impact of FibroBiologics' work on insulin-dependent diabetes?

FibroBiologics' work may lead to a new and durable potential allogeneic treatment option for people with insulin-dependent diabetes, offering hope for improved therapeutic options.

Who is the Chief Scientific Officer of FibroBiologics?

Hamid Khoja, Ph.D., is the Chief Scientific Officer of FibroBiologics, overseeing the development of innovative therapies for chronic diseases.

What is the goal of FibroBiologics' clinical program?

The goal of FibroBiologics' clinical program is to develop a minimally invasive therapeutic for type 1 diabetes, aiming to provide effective treatment options for patients.