HOUSTON, Sept. 19, 2024 (GLOBE NEWSWIRE) — FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 160+ 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 engaged with Southern Star Research to provide clinical research organization (CRO) services for FibroBiologics in Australia. Initial CRO services will include preparatory work for a Phase 1/2 clinical trial utilizing product candidate, CYWC628, to treat diabetic foot ulcers.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, said, “This engagement is an important step forward in creating the infrastructure for FibroBiologics to conduct clinical trials in Australia, including a planned Phase 1/2 clinical trial for CYWC628 to treat diabetic foot ulcers. We look forward to working with Southern Star Research to advance our fibroblast cell-based therapy. Australia offers an attractive destination for clinical trials due to its high-quality clinical trial infrastructure, regulatory environment and R&D incentives. We are confident that Southern Star Research will be a valuable partner in helping us achieve our clinical and regulatory milestones.”
“We are delighted to partner with FibroBiologics, a pioneer in the field of fibroblast cell-based therapies, to support their clinical development in Australia,” said David Lloyd, Managing Director of Southern Star Research. “We have extensive experience and expertise in conducting clinical trials across various therapeutic areas and indications, and we look forward to applying our skills and knowledge to this innovative and potentially life-changing therapy for diabetic foot ulcers.”
FibroBiologics’ CYWC628 is an allogeneic fibroblast cell-based therapy designed to promote and accelerate wound healing, particularly targeting diabetic foot ulcers that are difficult to treat and may result in infections that increase the risk of hospitalization, amputation, and death. CYWC628 enhances the ability of fibroblasts to survive and function in the wound environment, improving the body’s natural repair mechanisms and potentially offering a more effective treatment for chronic wounds.
For more information, please visit FibroBiologics’ website or email FibroBiologics at: [email protected].
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 CRO services to be provided under the master services agreement with Southern Star Research, expected research targets and indications of interest, plans for, and the timing of, clinical trials, and our relationship with Southern Star Research. 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) FibroBiologics’ ability to maintain the master services agreement with Southern Star Research; (b) risks related to FibroBiologics’ liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) expectations regarding the initiation, progress and expected results of R&D efforts and preclinical and clinical studies; and (d) 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 Southern Star Research
Founded in 2010 and headquartered in Sydney, Australia, Southern Star Research is a full-service CRO helping sponsors to navigate the complexities of bringing new medical products to market across the Asia Pacific region. Since commencing operations in Sydney, Southern Star Research has grown to become an international team of specialists, managing studies across the globe.
With a focus on the biotechnology and medical device industries, Southern Star Research offers flexible and bespoke solutions that meet the unique needs of each project. Southern Star Research are early phase specialists (Ph 1 and 2), with particular expertise in designing and managing clinical trials that ensure our Clients’ asset is ready for larger Ph 3 and 4 studies, licensing, partnering and acquisition. For more information, visit www.southernstarresearch.com
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 160+ 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.
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