FGF18

BOSTON, March 13, 2023 /PRNewswire/ -- Remedium Bio, a gene therapy company developing novel treatments for significant unmet needs, today announced the publication of pre-clinical data demonstrating the safety and chondrogenic activity of RMD1101, its innovative gene therapy for Osteoarthritis. These data are the first to be published from Remedium's ongoing research collaboration with Tufts University studying the approach. The paper, entitled "Adeno-Associated Virus-Delivered Fibroblast Growth Factor 18 Gene Therapy Promotes Cartilage Anabolism" will be published in Volume 14, Issue 1 of the journal Cartilage, and is available OnlineFirst. RMD1101 appears safe and effective at promoting cartilage anabolism Key Points AAV2-FGF18 appears to have a wide therapeutic safety window and is able to induce chondrogenesis at very low, locally administered doses The FGF18 gene therapy appears to induce chondrogenesis by increasing hyaline cartilage associated gene expression and promoting chondrocyte proliferation RMD1101 appears safe and effective at promoting cartilage anabolism in vivo, following a single intra articular injection "Having these results published in Cartilage provides important external validation of their significance" said Frank Luppino, President and CEO of Remedium. "Our findings confirm the chondrogenic mechanism after a single injection of RMD1101 and provide preliminary confirmation for the potential of the gene therapy approach to treating Osteoarthritis." RMD1101 is the only disease modifying gene therapy treatment for Osteoarthritis based on the clinically validated chondrogenic mechanism of FGF18. It is being studied as a single injection treatment for OA in both the human and companion animal markets. "Our results show the promise of treating Osteoarthritis by harnessing the endogenous regenerative power of articular cartilage with a single intra-articular injection FGF18 gene therapy," said Dr. Li Zeng, PhD, Associate Professor of Immunology at Tufts University School of Medicine. Dr. Zeng is a co-author of the publication and an expert in Osteoarthritis and the molecular and cellular mechanisms of the disease. Cartilage is a peer-reviewed, open access journal which publishes articles with a focus on recent discoveries related to the musculoskeletal system and cartilage repair, development, and regeneration. The Sage Publishing group, MEDLINE indexed journal publishes full length original manuscripts covering preclinical and clinical research, and is considered among the top journals in the field of cartilage regeneration. About Remedium Remedium Bio, Inc. is a preclinical-stage biotechnology company developing novel gene therapies for a broad range of highly debilitating diseases. The company's R&D approach focuses on modularly combining proven technologies to treat well-characterized disease pathology, thereby streamlining elements of the product development process. Remedium's pipeline includes a lead candidate first-in-class, single-injection, potentially disease-modifying gene therapy for the treatment of Osteoarthritis and treatments for the management of Diabetes and Stroke. To learn more, visit Contact Remedium: info@remedium-bio.com

Chesnot/Getty Images TrialSpark and Sanofi inked a three-year partnership to expedite drug development for areas with high unmet needs through the licensing or acquisition of six mid-to-late-stage drug candidates. New York-based TrialSpark and Sanofi aim to secure up to six best-in-class Phase II and Phase III drug candidates and develop them for diseases with high unmet needs. TrialSpark noted the deal harnesses its innovative clinical development program, which includes behavioral intervention and digital technologies, in order to deliver better outcomes for patients in need. The partnership was announced Tuesday, but the two companies noted work on this endeavor began in September. The companies did not disclose much about the partnership, only noting they will jointly pursue the six drug candidates together. The companies did not disclose any financial details, nor did they reveal what disease areas they aim to take on through the collaboration. TrialSpark’s own areas of interest include rheumatology, dermatology, CNS and cardiometabolic diseases. Although financing was not included in the announcement, TrialSpark raised $156 million in a Series C financing round last year. When that was announced, the company noted those funds were earmarked for the acquisition or licensing of clinical-stage assets. The funds were also tagged for potential investments in other pharma companies that have promising candidates. The Latest in a String of Collaborations TrialSpark’s business model includes the acquisition of assets considered undervalued by larger pharma and biotech companies. TrialSpark in-licenses and co-develops drug programs either in-house or through joint ventures and new companies launch. That model was on display earlier this year when TrialSpark licensed sprifermin, a potential first-in-class disease-modifying recombinant form of human fibroblast growth factor 18, from Merck KGaA. Sprifermin is being assessed as a potential treatment for osteoarthritis. The Germany-based Merck KGaA had taken the drug through mid-stage development, and TrialSpark intended to build on that with a Phase IIb and Phase III trial. In addition to the licensing, TrialSpark formed a new company, High Line Bio, to develop the drug. In order to rapidly advance drugs through the clinic, TrialSpark employs a ‘hub-and-spoke’ approach. The method aims to improve patient enrollment through establishing relationships with physicians and private practices in areas where trials are being conducted. That increases patient and physician access to research, the company claims. Combined with comprehensive trial management, that approach allows clinical studies to initiate at a faster pace, which speeds up the timeline for top-line data. TrialSpark and Sanofi are no strangers. Last year, Sanofi and TrialSpark partnered to increase the speed and efficiency of clinical trials for potential treatments for chronic obstructive pulmonary disease. Sanofi tapped into TrialSpark’s holistic approach to clinical trials that accelerate patient recruitment and enrollment while improving retention. Additionally, TrialSpark’s approach to recruitment was designed to increase minority participation in the studies, which is essential since many Hispanic and African Americans are challenged by COPD but have not historically been included in clinical research.

BOSTON, Aug. 15, 2022 /PRNewswire/ -- Remedium Bio, Inc., a biotechnology company developing novel gene therapies, today announced that it has closed more than $2.3M in its expanded seed round financing. Funding from the raise is being used to study Remedium's lead product, a single-injection gene therapy potentially capable of reversing cartilage loss, in a collaboration with Tufts University School of Medicine scientists researching rheumatic disorders. The financing was led by Sherwood Ventures and included participation from, LongevityTech.Fund, Primo Medical Group, Angel Star Ventures, Apis Health Angels, MicroVentures, and Guindy Alumni Angels. Potential to reverse years of age-related cartilage loss Remedium's lead candidate is the only single injection gene therapy based on the clinically proven anabolic mechanism of FGF18, which has demonstrated the ability to reverse cartilage loss in a placebo controlled, multi-center, randomized clinical trial. Osteoarthritis is the largest unmet need in Rheumatology, presenting a market of $37B with no currently approved therapies capable of slowing or reversing disease progression. Remedium's novel solution offers the potential to arrest disease progression after a single injection and promote restoration of a more natural, youthful phenotype of articular cartilage. "Our technology has the potential to reverse years of age-related cartilage loss, for a disease that currently has no approved therapeutic treatments capable of slowing or reversing progression," said Frank Luppino, President and CEO of Remedium Bio, Inc. "We are extremely excited about the progress made to date, and believe that our gene-augmentation technology can be translated to a number of other age-related pathologies with no currently available disease-modifying options." Remedium was founded by orthopedics industry veterans with proven track records of developing leading therapeutics at companies ranging from start-ups to Fortune 500. Remedium has attracted a number of academic collaborators and medical KOLs to its advisory board including Dr. Timothy McAlindon, MD, MPH, Chief of the Division of Rheumatology at Tufts Medical Center, Professor at Tufts University School of Medicine; Dr. Anastassios Pittas, MD, MS, Chief of the Division of Endocrinology, Diabetes, and Metabolism and Co-Director of the Diabetes and Lipid Center at Tufts Medical Center, Professor at Tufts University School of Medicine; Dr. Jeff Ellsworth, PhD, the pioneer of rhFGF18 technology and CSO of Recardia Therapeutics; Dr. Li Zeng PhD, MA, MS, BA Associate Professor Immunology at Tufts University School of Medicine; and Dr. Kai Zou PhD, Assistant Professor, Department of Exercise and Health Sciences, at the University of Massachusetts, Boston. Remedium's pipeline includes therapeutic indications in Osteoarthritis, Diabetes, Stroke, and other large unmet clinical needs. About Remedium Remedium Bio, Inc. is a preclinical-stage biotechnology company developing novel gene therapies for a broad range of highly debilitating diseases. The company's R&D approach focuses on modularly combining proven technologies to treat well-characterized disease pathology streamlining elements of the product development process. Remedium's pipeline includes a lead candidate first-in-class, single-injection, potentially disease-modifying gene therapy treatment for the treatment of Osteoarthritis and gene therapy treatments for the management of Diabetes and Stroke. To learn more, visit Contact Remedium: info@remedium-bio.com