Collaboration Brings Advanced Clinical Trial Technology to Support Filamon’s Growing Pipeline for Age-Related Chronic Inflammatory Diseases
CAMBRIDGE, Mass. and SYDNEY, Australia – September 4, 2025 – Pi Health, a global AI-native contract research organization today announced a strategic partnership with Filamon Limited, an Australian clinical-stage drug development company focused on next-generation anti-inflammatory drugs. The collaboration will utilize Pi Health’s proprietary FICS (Front-end Interoperable Capture Software) platform and comprehensive CRO services to support Filamon’s Phase I/II ADVICE study for kesonotide in advanced solid cancers across multiple Australian sites.
The ADVICE study is seen as a potential major step forward in the management of cancer in using the drug candidate, kesonotide, in a world-first effort to block the inflammatory response created by cancer cells to promote tumour growth and invasiveness.
Filamon is developing treatments for age-related chronic inflammatory diseases that account for most hospitalizations and deaths in developed countries, with target indications including solid cancers, ophthalmic diseases including macular degeneration, and neurological diseases including dementia. The partnership with Pi Health provides Filamon with an extended suite of services encompassing traditional clinical trial conduct and delivery, through to assistance in business development.
The ADVICE study is aimed to be the first clinical trial of several that Pi Health will support as Filamon grows and expands its pipeline of innovative assets over time.
Pi Health’s unique and disruptive CRO business model replaces fragmented clinical trial systems with a unified solution powered by AI that automates clinical documentation, streamlines data collection, and enables regulatory-grade data capture, addressing the inefficiencies that currently impede progress in clinical development.
“We’re developing a highly differentiated, growing pipeline of drug candidates that hold potential for breakthroughs in major medical needs and we see this partnership with Pi Health as a logical step,” said Dr. Graham Kelly, Filamon CEO and Managing Director. “It gives us access to the sort of world-class services a much larger drug development company would have, allowing us to focus our time and resources on drug discovery and development with the goal of bringing a new generation of anti-inflammatory drugs to the market as quickly as possible.”
The partnership underscores Pi Health’s expanding presence in Australia, where the company has established five clinical trial site partnerships along with dedicated in-country support since building its network in the region.
“Pi Health is strongly positioned to help biotechs like Filamon run clinical studies and expand beyond with industry-leading precision, speed and quality,” said Dr. Ro Wickramasinghe, Global Head of Business Development and General Manager, Australia at Pi Health. “We have a strong presence and track record of success in Australia, and we are rapidly expanding our capabilities to meet both local and global demand for our unique services.”
“This collaboration exemplifies our mission to democratize access to innovative medicines by supporting biotechnology companies in bringing life-saving treatments to patients,” said Dr. Geoff Kim, Co-Founder and CEO of Pi Health. “Our AI-powered platform enables companies like Filamon to accelerate their clinical programs while maintaining the highest standards of data quality and regulatory compliance.”
About Pi Health
Pi Health is an AI-native contract research organization (CRO) transforming global access to innovative medicines and clinical trials. Powered by its proprietary FICS® platform—embedded with fine-tuned large language models—Pi Health integrates full-service clinical research capabilities with a growing network of technology-enabled sites across five continents. This unified approach delivers breakthrough efficiencies, cost savings, and perpetual regulatory-grade data quality for sponsors and sites alike. With its rapidly expanding global footprint, Pi Health is making clinical trial participation accessible to patients everywhere. To learn more, visit pihealth.ai.
About Filamon Limited
Filamon is an Australian, public, unlisted drug development company focused on the development of next generation anti-inflammatory drugs for age-related chronic inflammatory diseases accounting for most hospitalisations and deaths in developed countries. The Company is leveraging groundbreaking research and technology for target indications including solid cancers with inflammatory cores, ophthalmic diseases including wet AMD and dry AMD, and tauopathies including Alzheimer’s Disease, Pick’s Disease, chronic traumatic encephalopathy and progressive supranuclear palsy.
Kesonotide is the Company’s clinical-stage drug asset . Pre-clinical assets currently under development are (i) BETA-TT8, a MEK1 inhibitor as a topical (eyedropper) product for wet AMD, (ii) BETA-TT17, a MEK1 inhibitor/cJun promoter as an oral reverser of T-cell exhaustion in solid cancers, and (ivi) ALPHA-D3, an inhibitor of tau oligomer formation for a range of tauopathies.
About Kesonotide
Kesonotide is the subject of the ADVICE Phase Ib/IIa trial involving 80 patients with late-stage, metastatic cancers of types known to over-express the pro-inflammatory protein hGIIA and EGF growth factor. Kesonotide blocks the ability of those pro-inflammatory ligands from activating vimentin and that protein’s role in the establishment and function of the tumour micro-environment and the promotion of cancer cell proliferation, aggression, invasiveness, chemo-resistance and immune dysfunction. The primary cancer types being studied are carcinomas of the lung, prostate, breast, pancreas, large bowel and brain.
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