FibroBiologics Announces Positive IND-Enabling Updates Demonstrating Potential of Fibroblast Spheroids in Chronic-Relapse Psoriasis Treatment
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.
FibroBiologics (NASDAQ:FBLG) ha comunicato aggiornamenti positivi per l'IND relativi al suo programma contro la psoriasi basato su sfere di fibroblasti dermici umani (HDF). L'azienda riferisce che una singola somministrazione di sfere HDF ha raggiunto la stessa efficacia di dosi ripetute di un anticorpo monoclonale anti-IL-23 in un modello di psoriasi acuta, riducendo inoltre in modo significativo le recidive in un modello di malattia cronica a ricadute.
La biotech, titolare di oltre 270 brevetti concessi e in richiesta, sta proseguendo la ricerca con studi pilota su regimi di somministrazione ripetuta, profili di citochine e valutazioni istopatologiche. Il trattamento è indirizzato alla psoriasi, una malattia autoimmune che colpisce più di 8 milioni di adulti negli Stati Uniti, e potrebbe avere applicazioni nel più ampio mercato delle malattie infiammatorie croniche.
FibroBiologics (NASDAQ:FBLG) ha anunciado actualizaciones positivas para el IND de su programa contra la psoriasis basado en esferoides de fibroblastos dérmicos humanos (HDF). La compañía informó que una única administración de esferoides HDF igualó la eficacia de dosis múltiples de un anticuerpo monoclonal anti-IL-23 en un modelo de psoriasis aguda, y además redujo de manera significativa las recurrencias en un modelo de recaída crónica.
La biotecnológica, con más de 270 patentes concedidas y en trámite, avanza su investigación mediante estudios piloto centrados en regímenes de dosis repetidas, perfilado de citoquinas y evaluaciones histopatológicas. El tratamiento está dirigido a la psoriasis, una enfermedad autoinmune que afecta a más de 8 millones de adultos en Estados Unidos, con potencial para abordar el mercado más amplio de enfermedades inflamatorias crónicas.
FibroBiologics (NASDAQ:FBLG)는 인간 진피 섬유아세포(HDF) 스페로이드 기반 건선 치료 프로그램에 대한 IND 승인 지원 업데이트를 발표했습니다. 회사는 단회 투여된 HDF 스페로이드가 급성 건선 모델에서 항-IL-23 단일클론항체의 다회 투여와 동등한 효능을 보였고, 만성 재발 모델에서는 질병 재발을 유의미하게 감소시켰다고 보고했습니다.
270건 이상의 특허(등록 및 출원 중)을 보유한 이 바이오텍은 반복 투여 요법, 사이토카인 프로파일링 및 조직병리학적 평가에 중점을 둔 파일럿 연구를 진행 중입니다. 이 치료법은 미국에서 8백만 명이 넘는 성인에게 영향을 미치는 자가면역 질환인 건선을 표적으로 하며, 만성 염증성 질환의 광범위한 시장에도 적용될 가능성이 있습니다.
FibroBiologics (NASDAQ:FBLG) a annoncé des mises à jour favorables pour l'IND de son programme contre le psoriasis utilisant des sphéroïdes de fibroblastes dermiques humains (HDF). La société rapporte qu'une administration unique de sphéroïdes HDF a égalé l'efficacité de doses multiples d'un anticorps monoclonal anti-IL-23 dans un modèle de psoriasis aigu, tout en réduisant significativement la récurrence de la maladie dans un modèle de rechute chronique.
La biotech, détentrice de plus de 270 brevets délivrés et en cours, poursuit ses recherches par des études pilotes axées sur des schémas de doses répétées, le profilage des cytokines et des évaluations histopathologiques. Le traitement vise le psoriasis, une maladie auto-immune qui touche plus de 8 millions d'adultes aux États-Unis, et pourrait s'étendre au marché plus large des maladies inflammatoires chroniques.
FibroBiologics (NASDAQ:FBLG) hat positive IND-relevante Neuigkeiten zu seinem Psoriasis-Programm mit humanen dermalen Fibroblasten(HDF)-Spheroiden bekanntgegeben. Das Unternehmen meldet, dass eine einzelne Applikation von HDF-Spheroiden die Wirksamkeit mehrfacher Dosen eines Anti-IL-23-Monoklonalantkörpers in einem akuten Psoriasis-Modell erreichte und gleichzeitig in einem chronisch-rezidivierenden Modell das Wiederauftreten der Erkrankung deutlich verringerte.
Die Biotech-Firma, die über 270 Patente erteilt bzw. angemeldet hat, treibt ihre Forschung mit Pilotstudien zu wiederholten Dosierungsregimen, Zytokinprofilen und histopathologischen Untersuchungen voran. Die Behandlung richtet sich gegen Psoriasis, eine Autoimmunerkrankung, die mehr als 8 Millionen Erwachsene in den USA betrifft, und könnte auch auf den breiteren Markt chronisch-entzündlicher Erkrankungen abzielen.
- 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
- Treatment still in early preclinical stage, requiring further studies
- No clinical trial data available yet
- Faces regulatory hurdles and approval processes before commercialization
Insights
FibroBiologics' fibroblast spheroids show strong potential in psoriasis treatment with single-dose efficacy matching multi-dose standard therapies.
FibroBiologics has reported compelling preclinical data for its human dermal fibroblast (HDF) spheroid technology in psoriasis treatment. The company's innovative approach shows two key advantages over existing therapies: efficacy with a single administration that matches multiple doses of anti-IL-23 antibodies in acute psoriasis models, and significant reduction in disease recurrence in chronic-relapse models.
This represents meaningful differentiation in the crowded inflammatory disease market. Current biologics for psoriasis typically require multiple injections on a regular schedule to maintain efficacy. A single-administration therapy with durable response could substantially improve treatment adherence and patient quality of life while potentially reducing lifetime treatment costs.
The company's focus on the chronic-relapse model is particularly significant as it addresses one of the most challenging aspects of psoriasis management - preventing flare-ups. Most current therapies require continuous administration to prevent relapse, creating both compliance challenges and ongoing expense.
It's important to note these results remain in the preclinical stage. The company is conducting additional mechanistic studies including cytokine profiling and histopathological assessments to strengthen their IND package before human trials. While promising, the translation of these findings to clinical outcomes remains to be proven, as management acknowledged with their cautionary statements about the unpredictable relationship between preclinical and clinical results.
The scientific approach FibroBiologics is pursuing represents an interesting shift in psoriasis treatment paradigms. Rather than targeting specific inflammatory cytokines like IL-17 or IL-23 (the mechanism of most approved biologics), they're utilizing fibroblast spheroids - three-dimensional cellular structures that likely provide multiple immunomodulatory functions simultaneously.
What's particularly noteworthy is the apparent sustained effect from a single administration in their chronic-relapse model. This suggests the therapy may be modulating fundamental immune dysregulation rather than simply suppressing symptoms temporarily. The fact that a single treatment reduces disease recurrence points to potential disease-modifying capabilities that current maintenance therapies don't achieve.
The comparison to anti-IL-23 antibodies provides a valuable benchmark, as these represent some of the most effective current treatments. IL-23 inhibitors typically achieve
From an immunological perspective, fibroblasts can secrete various anti-inflammatory cytokines and extracellular matrix components that help normalize tissue homeostasis. Their spheroid format likely enhances cell survival and prolongs therapeutic effect compared to traditional cell suspensions. The planned systemic and local cytokine profiling will be crucial for understanding whether this approach modulates specific inflammatory pathways or creates broader immunoregulatory effects that current targeted therapies cannot achieve.
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.
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