Guard Therapeutics

The program began with the company's CEO, Tobias Agervald, providing a summary of the strategic considerations and positive feedback from the FDA that form the basis for the next development stages of RMC-035, including a planned Phase 2b study in open-heart surgery. Furthermore, the discussion also covered the way forward and the strategy for an upcoming pivotal Phase 3 study.

Professor David Goldsmith, adjunct professor at King's College in London and a globally recognized Key Opinion Leader in nephrology, delivered a comprehensive presentation on irreversible loss of kidney function following open-heart surgery, highlighting the lack of specific treatment options despite the significant medical need. Professor Goldsmith also discussed the main findings of the AKITA study, which included positive and clinically relevant long-term effects on kidney function after treatment with RMC-035.

The company's Chief Medical Officer, Dr. Michael Reusch, then introduced POINTER - the planned Phase 2b study in open-heart surgery - including its overall design and timelines.

CEO Tobias Agervald then presented new advancements in the company's preclinical development platform, the so-called GTX platform, aimed at developing new peptides (short protein fragments) based on the endogenous protein alpha-1-microglobulin. The overall goal is to identify new drug candidates tailored for the treatment of chronic diseases. The peptide GTX-86, along with other similar peptides, has demonstrated robust therapeutic effects in several experimental models representing various forms of kidney disease, including kidney injuries caused by oxygen deprivation (known as ischemia-reperfusion injury) and by the chemotherapy agent cisplatin. Additional concept validation studies have also been conducted with up to 28 days of treatment in two models of chronic kidney disease, including diabetes-induced kidney disease and focal segmental glomerulosclerosis (FSGS). With these results, the company sees promising opportunities to strengthen and expand its position in several new potential therapy areas, including chronic kidney disease.

The day concluded with a brief summary by CEO Tobias Agervald and an open Q&A session.

All presentations from the day can be viewed here: https://youtube.com/live/Enob5jUFw8I