FesariusTherapeutics Inc. I-Corps Program to Benefit the development and sales of its flagship product DermiSphere(tm)

FesariusTherapeutics Inc. I-Corps 计划将有利于其旗舰产品 DermiSphere(tm) 的开发和销售

• 批准号: 10045902
• 负责人: Yulia Sapir Lekhovitser
• 金额: $ 5.5万
• 依托单位: FESARIUSTHERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045902
• 关键词: 3-Dimensional; Architecture; Autologous; Autologous Transplantation; Biological; Capital; Cattle; Cells; Cicatrix; Clinical Trials; Collagen; Data; Dermal; Dermis; Development; Engineering; Excision; Family suidae; Formulation; Goals; Gold; Health Care Costs; Human body; Hydrogels; Impaired wound healing; In Vitro; Innovation Corps; Lead; Legal patent; Methods; Microscopic; Morbidity - disease rate; Mus; Natural regeneration; Operative Surgical Procedures; Patients; Pattern; Penetration; Phase; Procedures; Reconstructive Surgical Procedures; Sales; Site; Skin; Small Business Innovation Research Grant; Technology; Testing; Thick; Time; Tissues; Vascularization; Wound models; biomaterial compatibility; chronic wound; commercialization; cytotoxicity; disability; efficacy testing; healing; improved; in vivo; neovascularization; novel; operation; phase 1 study; phase 2 study; preclinical safety; programs; prototype; reconstruction; response; safety testing; scaffold; skin wound; standard care; success; wound; wound bed; wound closure; wound healing

DermiSphere™: An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery ABSTRACT On its own, the human body is incapable of dermis regeneration. If not properly treated, large full-thickness skin wounds (loss of dermis) heal through contraction of surrounding skin and scar formation, which may ultimately lead to chronic wound formation, permanent damage, disability, disfigurement and patient suffering. For years, the autologous tissue transfer (a patient serving as their own donor) has been the gold-standard treatment for this type of wound, but lack of surgical expertise, poor donor site availability and significant donor-site morbidity severely limit its application. In the early 2000s, alternative, “off the shelf” neo-dermis formation treatments emerged, which now have annual sales between $500 million to $1 billion, growing 8- 12% annually. The leading product by sales, Integra™, possesses shortcomings in its time to heal and is ineffective in many types of full thickness wound scenarios. DermiSphere™, the proposed product of this SBIR Phase I application will be an implantable scaffold that rapidly restores patients’ functional dermis. DermiSphere’s patented three-dimensional microscopically patterned architecture guides rapid cell penetration from the wound bed into the scaffold matrix, leading to rapid vascularization and neo-dermal tissue formation. Our murine studies to date demonstrate DermiSphere’s superior invasion and neovascularization versus Integra. The collective long-term goal of our SBIR Phase I proposal and contemplated Phase II study is a DermiSphere prototype, ready for clinical trial, that triggers rapid dermal regeneration while avoiding skin contraction and scarring. When compared to currently available dermal substitutes, DermiSphere will induce faster wound closure, form more functional tissue, and lessen required procedures, reducing patient suffering and materially reducing health care cost. In this Phase I study we will prove the feasibility of our product by completing the following Specific Aims: (1) Demonstrate DermiSphere biocompatibility by testing its potential cytotoxicity in vitro by elution method, when formulated using bovine collagen. Criteria for Success: Biological response to DermiSphere is less than or equal to slight reactivity. (2) Demonstrate DermiSphere’s ability to support rapid dermal regeneration in a pilot in vivo swine full-thickness excisional wound model. Criteria for Success: Epidermal take ≥75% on day 21 of the study and wound contraction ≤20% and ≤30% on days 14 and 60 of the study respectively. Our Phase II study will be a full- scale, full thickness excisional swine wound model to validate DermiSphere’s efficacy over Integra. Data from this study will also be used to improve formulation for both scale manufacturing and for pre-clinical safety and efficacy testing requirements. Demonstrating DermiSphere’s superior efficacy over Integra in a full-scale wound model is currently our first major strategic milestone. Achieving this milestone will sufficiently increase the equity value of FesariusTherapeutics Inc. to attract the capital needed to scale operations for increased manufacturing, FDA submission and commercialization.

DermiSphere™：用于重建手术的高级真皮再生支架 摘要 就其本身而言，人体无法进行真皮再生。如果处理不当， 皮肤创伤（真皮的损失）通过周围皮肤的收缩和瘢痕形成而愈合， 最终导致慢性伤口形成、永久性损伤、残疾、毁容和患者痛苦。 多年来，自体组织移植（患者作为自己的供体）一直是黄金标准 治疗这种类型的伤口，但缺乏外科专业知识，供体部位可用性差， 供体部位发病率严重限制了其应用。在21世纪初，替代性的“现成”新真皮 地层处理出现了，现在年销售额在5亿美元到10亿美元之间，增长了8- 每年12%。销售额领先的产品Integra™在其愈合时间方面存在缺陷， 在许多类型的全厚度伤口情况下无效。DermiSphere™，本申请的申报产品 SBIR第一阶段的应用将是一种可植入的支架，可快速恢复患者的功能性真皮。 DermiSphere的专利三维显微图案化结构引导快速细胞渗透 从伤口床进入支架基质，导致快速血管化和新皮肤组织形成。 迄今为止，我们的小鼠研究证明DermiSphere的上级侵袭和新生血管形成优于 Integra我们的SBIR第一阶段建议和预期的第二阶段研究的共同长期目标是 DermiSphere原型，准备进行临床试验，在避免皮肤接触的同时， 收缩和疤痕。与目前可用的真皮替代品相比，DermiSphere将诱导 更快的伤口闭合，形成更多的功能组织，并减少所需的程序，减少患者的痛苦 并实质上降低了医疗成本。在第一阶段研究中，我们将通过以下方式证明我们产品的可行性： 完成以下具体目标：（1）通过测试DermiSphere的生物相容性， 当使用牛胶原配制时，通过洗脱法进行体外潜在细胞毒性试验。标准 成功：DermiSphere的生物学反应小于或等于轻微反应。(2)证明 DermiSphere在试验性猪体内全层皮肤中支持快速皮肤再生的能力 切除伤口模型。成功标准：研究第21天表皮吸收≥75%且伤口 研究第14天和第60天收缩分别≤20%和≤30%。我们的第二阶段研究将是一个完整的- 比例、全层切除猪伤口模型，以验证DermiSphere相对于Integra的有效性。数据从 该研究还将用于改进制剂，以用于规模生产和临床前安全性， 功效测试要求。在全尺寸试验中证明DermiSphere的上级疗效优于Integra 伤口模型是目前我们的第一个重大战略里程碑。实现这一里程碑将充分增加 FesariusTherapeutics Inc.的股权价值为了吸引扩大业务所需的资本， 制造、FDA提交和商业化。