FibroBiologics Receives HREC Approval for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers
FibroBiologics (Nasdaq: FBLG) announced HREC approvals in Australia for a Phase 1/2 trial of its topical allogeneic fibroblast therapy CYWC628 to treat refractory diabetic foot ulcers.
The approval and completed TGA filing enable enrollment of 120 patients at 10 Australian sites. Southern Star Research will manage the multicenter, randomized study evaluating safety, tolerability, and efficacy with low/high dose arms plus standard of care. An interim analysis will occur after a predefined cohort completes six weeks of treatment.
FibroBiologics (Nasdaq: FBLG) ha annunciato l'approvazione HREC in Australia per uno studio di fase 1/2 della sua terapia topica allogenica di fibroblasti CYWC628 per trattare le ulcere del piede diabetiche refrattarie.
L'approvazione e la presentazione TGA completata permettono l'iscrizione di 120 pazienti in 10 siti australiani. Southern Star Research gestirà lo studio multicentrico, randomizzato, che valuta sicurezza, tollerabilità ed efficacia con bracci a dose bassa/alta oltre al trattamento standard. Un'analisi intermedia avrà luogo dopo che una coorte predefinita avrà completato sei settimane di trattamento.
FibroBiologics (Nasdaq: FBLG) anunció aprobaciones HREC en Australia para un ensayo de fase 1/2 de su terapia tópica de fibroblastos alogénicos CYWC628 para tratar las úlceras del pie diabéticas refractarias.
La aprobación y la presentación ante la TGA completada permiten la inscripción de 120 pacientes en 10 sitios en Australia. Southern Star Research gestionará el estudio multicéntrico, aleatorizado, que evalúa seguridad, tolerabilidad y eficacia con brazos de dosis baja/alta además del cuidado estándar. Un análisis interino tendrá lugar después de que una cohorte predefinida complete seis semanas de tratamiento.
FibroBiologics (나스닥: FBLG)은 호주에서 재발성 당뇨발 궤를 치료하기 위한 국소 동종 유래 섬유아세포 치료제 CYWC628의 1/2상 시험에 대한 HREC 승인을 발표했습니다.
승인 및 완료된 TGA 제출은 120명의 환자를 호주 10개 사이트에서 등록 가능하게 합니다. Southern Star Research는 안전성, 내약성 및 유효성을 평가하는 다기관 무작위 연구를 관리하며, 저용량/고용량 병용 및 표준 치료를 포함합니다. 사전에 정의된 코호트가 6주의 치료를 완수한 후 중간 분석이 실시됩니다.
FibroBiologics (Nasdaq: FBLG) a annoncé des approbations HREC en Australie pour un essai de phase 1/2 de sa thérapie topique à base de fibroblastes allogéniques CYWC628 pour traiter les ulcères du pied diabétiques réfractaires.
L'approbation et le dépôt TGA complété permettent l'inscription de 120 patients dans 10 sites australiens. Southern Star Research gérera l'étude multicentrique, randomisée, évaluant la sécurité, la tolérance et l'efficacité avec des bras à faible/haute dose en plus des soins standards. Une analyse intermédiaire aura lieu après qu'une cohorte prédéfinie aura terminé six semaines de traitement.
FibroBiologics (Nasdaq: FBLG) hat HREC-Genehmigungen in Australien für eine Phase-1/2-Studie seiner topischen allogenen Fibroblasten-Therapie CYWC628 zur Behandlung refraktärer diabetischer Fußgeschwüre angekündigt.
Die Zulassung und die abgeschlossene TGA-Einreichung ermöglichen die Einschreibung von 120 Patienten an 10 australischen Standorten. Southern Star Research wird die multizentrische, randomisierte Studie leiten, die Sicherheit, Verträglichkeit und Wirksamkeit mit niedrigen/hohen Dosierungsarmen neben der Standardbehandlung bewertet. Eine Zwischenanalyse erfolgt, nachdem eine vordefinierte Kohorte sechs Wochen Behandlung abgeschlossen hat.
FibroBiologics (ناسداك: FBLG) أعلنت عن موافقات HREC في أستراليا لتجربة من المرحلة 1/2 لعلاجها الموضعي بالخلايا الليفية المتماثلة CYWC628 لقرح القدم السكرية المستعصية.
تتيح الموافقة وطرح TGA المكتمل تسجيل 120 مريضاً في 10 مواقع أسترالية. ستدير Southern Star Research الدراسة متعددة المراكز العشوائية التي تقيم السلامة والتحمل والفعالية مع أذرع بجرعات منخفضة/عالية بالإضافة إلى معيار الرعاية. سيجري تحليل وسيط بعد أن تكمل كوهوهة محددة مسبقاً ستة أسابيع من العلاج.
- HREC approvals secured for Australian Phase 1/2 trial
- Enrollment enabled for 120 patients across 10 sites
- TGA filing completed, regulatory filings submitted
- Contracted Southern Star Research as full-service CRO
- Early-stage Phase 1/2 trial; clinical efficacy not yet established
- Enrollment limited to 120 patients, constraining power
- Results pending; primary endpoints subject to interim review at 6 weeks
Insights
HREC and TGA clearances enable a 120-patient Phase 1/2 trial of CYWC628 in refractory diabetic foot ulcers, advancing clinical validation.
FibroBiologics has secured both public and private HREC approvals and completed the TGA filing as of
The main dependencies are operative trial execution and data integrity: timely site start‑up, recruitment of the intended 120 patients, consistent wound assessment and imaging, and adherence to the planned interim analysis after participants complete
Watch for enrollment milestones, the predefined interim analysis result after the
HOUSTON, Nov. 20, 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 that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers (DFU). This approval enables enrollment of 120 patients at 10 sites across Australia. With the HREC approval and Therapeutics Goods Administration (TGA) filing now complete, FibroBiologics has secured all necessary regulatory approvals and submitted all required filings to proceed with the clinical trial.
Southern Star Research, a leading full-service Australian CRO with APAC coverage, will manage all aspects of the CYWC628 trial from start to finish. “We are honored to continue our partnership with FibroBiologics whose leadership in cell therapy and regenerative medicine truly inspires us.” said Lloyd Prescott, CEO of Southern Star Research.
The approved clinical trial is a prospective, multicenter, randomized study designed to evaluate the safety, tolerability, and efficacy of FibroBiologics’ investigational topically administered allogeneic fibroblast cell-based therapy, CYWC628, for the treatment of refractory DFU. Participants will receive up to 12 weeks of treatment using either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone.
The trial will assess wound healing outcomes, efficacy of response, and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints.
“We’re excited to receive HREC approvals for our Phase 1/2 trial in refractory diabetic foot ulcers,” said Pete O’Heeron, Founder and CEO of FibroBiologics. “This is an important milestone. It moves our fibroblast-based platform into real-world clinical testing. What we learn from this study could potentially help unlock a new class of cell therapies for chronic wounds—an area where patients have been underserved for far too long. This is exactly the kind of long-term, high-impact work that drives our mission.”
In addition to confirming safety and therapeutic potential, the study is expected to provide key clinical data supporting CYWC628 as a novel, fibroblast-based cell therapy aimed at addressing a significant unmet need in chronic wound management.
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 plans for, and the anticipated timing of the initiation of and results from, FibroBiologics’ clinical trials and research and development programs, and the potential clinical benefits of fibroblasts and fibroblast-derived materials. 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 FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications, (e) FibroBiologics’ ability to manufacture its product candidates; and (f) FibroBiologics’ ability to conduct clinical trials. 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 CYWC628
CYWC628 is an investigational topically administered allogeneic fibroblast cell-based therapy for wound healing. Preclinical data suggest CYWC628 may significantly accelerate wound healing compared to currently available treatments.
FibroBiologics is conducting a prospective, multicenter, randomized clinical trial evaluating the safety, tolerability, and efficacy of CYWC628 in treating refractory diabetic foot ulcers with up to 12 weeks of treatment using either standard of care plus a low or high-dose of CYWC628, or standard of care only.
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
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Nic Johnson
Russo Partners
(212) 845-4242
fibrobiologicsIR@russopr.com
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FAQ
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