FibroBiologics Announces Positive IND-Enabling Updates Demonstrating Potential of Fibroblast Spheroids in Chronic-Relapse Psoriasis Treatment
Rhea-AI Summary
FibroBiologics (NASDAQ:FBLG) has announced positive IND-enabling updates for its psoriasis treatment program using human dermal fibroblast (HDF) spheroids. The company reported that a single administration of HDF spheroids matched the efficacy of multiple doses of an anti-IL-23 monoclonal antibody in an acute psoriasis model, while also significantly reducing disease recurrence in a chronic-relapse model.
The biotechnology company, which holds over 270 patents issued and pending, is advancing its research through pilot studies focused on repeated dosing regimens, cytokine profiling, and histopathological assessments. The treatment targets psoriasis, an autoimmune condition affecting more than 8 million adults in the United States, with potential to address the broader chronic inflammatory disease market.
Positive
- Single HDF spheroid treatment matched efficacy of multiple anti-IL-23 antibody doses
- Significant reduction in disease recurrence demonstrated in chronic-relapse model
- Large addressable market with over 8 million adults affected by psoriasis in the US
- Strong intellectual property portfolio with 270+ patents issued and pending
Negative
- Treatment still in early preclinical stage, requiring further studies
- No clinical trial data available yet
- Faces regulatory hurdles and approval processes before commercialization
News Market Reaction – FBLG
On the day this news was published, FBLG gained 3.94%, reflecting a moderate positive market reaction. This price movement added approximately $897K to the company's valuation, bringing the market cap to $23.66M at that time.
Data tracked by StockTitan Argus on the day of publication.
Pilot studies underway to advance IND-enabling preclinical development
HOUSTON, Sept. 11, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis.
Psoriasis is a serious autoimmune condition affecting over eight million adults in the United States. In many cases, it progresses to psoriatic arthritis, significantly impacting quality of life. FibroBiologics is focused on harnessing fibroblast science to develop therapies that are not just incremental improvements, but durable, scalable solutions for patients.
“In an acute psoriasis model, a single administration of HDF spheroids matched the efficacy of multiple doses of an anti-IL-23 monoclonal antibody. Now, in a chronic-relapse model, that same single treatment has been shown to significantly reduce disease recurrence,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics.
The company is continuing to expand its research, including exploring repeated dosing regimens, systemic and local cytokine profiling, and histopathological assessments of skin lesions. These efforts are designed to deepen understanding of the mechanisms at work and strengthen the foundation for clinical advancement.
“These IND-enabling results are a pivotal milestone on our path to building a category-defining company in regenerative medicine,” said Pete O’Heeron, Founder and Chief Executive Officer at FibroBiologics. “Chronic inflammatory diseases represent a massive, underserved market, and the ability to address them at scale is a generational opportunity. At FibroBiologics, we’re relentlessly focused on durability, safety, and reproducibility—because those are the levers that unlock scalability and market leadership. The breakthroughs our scientists achieve strengthen the evidence base and bring us closer to creating long-term value for both patients and shareholders.”
FibroBiologics is now evaluating whether a single HDF spheroid treatment can be developed to deliver long-term protection against psoriasis relapse, an outcome that would represent not just progress, but a step-change in how chronic inflammatory diseases are treated.
For more information, please visit FibroBiologics' website or email FibroBiologics at: info@fibrobiologics.com.
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 and capabilities of human dermal fibroblast (HDF) spheroids to treat chronic-relapse psoriasis. 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. 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) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; and (d) the ability of FibroBiologics to successfully prosecute its patent applications. 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 clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com.
General Inquiries:
info@fibrobiologics.com
Investor Relations:
Nic Johnson
Russo Partners
(212) 845-4242
fibrobiologicsIR@russopr.com
Media Contact:
Liz Phillips
Russo Partners
(347) 956-7697
Elizabeth.phillips@russopartnersllc.com
FAQ
What are the latest clinical developments for FibroBiologics (FBLG) psoriasis treatment?
How many patents does FibroBiologics (FBLG) currently hold?
What is the market potential for FibroBiologics' (FBLG) psoriasis treatment?
What are the next steps in FibroBiologics' (FBLG) psoriasis treatment development?
How does FibroBiologics' (FBLG) HDF spheroid treatment differ from current psoriasis treatments?
