This announcement was originally published by Island Pharmaceuticals.
Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to advise that it has executed a Statement of Work (SOW) with Texas Biomedical Research Institute (Texas Biomed) to further advance Galidesivir’s Animal Rule development for the treatment of Marburg Virus Disease.
The SOW, executed under the existing Master Services Agreement between Island and Texas Biomed, establishes the second phase of the Company’s dose optimisation program, a key component of the regulatory package required to support the design of Galidesivir’s planned pivotal Animal Rule efficacy study.
The program has been designed in accordance with feedback from the U.S. Food and Drug Administration (FDA), which confirmed Galidesivir’s regulatory pathway under the Animal Rule and recommended the completion of dose optimisation studies before finalising the pivotal study design.
The Company’s dose optimisation program commenced under Island’s Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases.
The execution of the Texas Biomed SOW expands this program through a complementary study at a second biosafety level 4 (BSL-4) facility, with the combined studies expected to generate the data required to optimise dose selection and finalisethe design of the Company’s planned pivotal Animal Rule efficacy study.
The Texas Biomed study represents the second phase of Island’s FDA-directed dose optimisation program and has been designed to complement the ongoing USAMRIID study. While the USAMRIID program is evaluating the minimally effective dose when treatment is initiated 24 to 48 hours following infection, the Texas Biomed study will assess Galidesivir when treatment commences on days that correlate with first signs of clinical viral disease, typically between 3 and 5 days following infection.
Collectively, the studies are expected to generate the pharmacokinetic, efficacy and treatment timing data required to identify the minimally effective dose, optimise pivotal study parameters and strengthen the regulatory package for discussions with the FDA ahead of the planned Animal Rule efficacy study.
Texas Biomed is one of only four BSL-4 facilities in the United States capable of conducting non-human primate infectious disease studies and is the only privately operated BSL-4 laboratory. Its specialised capabilities in high-consequence pathogens, including Marburg virus, make it a globally recognised partner for the development of medical countermeasures against emerging infectious diseases
Cory Hallam, Ph.D., Executive Vice President, Applied Science and Innovation at Texas Biomed, said: “Texas Biomed serves as a critical national resource for evaluating medical countermeasures against high-consequence infectious diseases. Our decades of experience, advanced high-containment laboratories and specialised non-human primate research capabilities enable us to help move promising therapies toward clinical development. This partnership with Island Pharmaceuticals underscores Texas Biomed’s role in supporting government and industry partners in the United States and around the world as we work together to strengthen global biodefense preparedness.”
Chief Executive Officer and Managing Director, Dr David Foster, said: “Working with an institution of Texas Biomed’s calibre represents another important milestone for Island and reflects the quality of the partners supporting the development of Galidesivir. As one of the world’s leading high-containment infectious disease research organisations, Texas Biomed brings exceptional expertise to a program targeting one of the most significant unmet needs in emerging infectious diseases and global biodefence.
Marburg virus remains a recognised bioterrorism threat with no broadly available approved antiviral treatments, making it essential that we execute a disciplined and scientifically rigorous development program.
The FDA has provided a clear roadmap to advance Galidesivir under the Animal Rule, and these complementary dose optimisation studies are a critical part of that pathway. By investing the time now to optimise dose selection and pivotal study design, we expect to materially de-risk the program before progressing into the pivotal efficacy study.
Our objective is to enter pivotal development with the strongest possible scientific and regulatory foundation, maximising the probability of a successful outcome while continuing to build the long-term value of the Galidesivir program.”
About Island Pharmaceuticals
Island (ASX: ILA) is focused on areas of unmet need for drugs that can address urgent viral diseases, public health or biosecurity threats. The Company is executing a dual development strategy for its assets, ISLA-101 and Galidesivir. ISLA-101 has a well-established safety profile, being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases. Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in over 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever – viruses with significant unmet medical needs and that may contribute to national security threats.
Visit www.islandpharmaceuticals.com for more on Island.