Leaf4Life Engages Phase Advance To Predict Clinical Outcomes for 16 Phase 3 Trials
Phase Advance layers non-LLM AI modules over cradle-to-grave nonlinear mathematical models of human lifespans to predict how newly discovered drugs will perform in Phase 3 clinical trials.
Leaf4Life is a biopharmaceutical company dedicated to developing transformative therapies for hypoxia across critical diseases.
Advanced clinical modeling firm to provide in silico projections of KizaVie™ drug performance for over a dozen therapeutic indications.
DALLAS, TX, UNITED STATES, June 22, 2026 /EINPresswire.com/ -- Leaf4Life today announced a strategic collaboration with Phase Advance (PAI) to forecast Phase 3 clinical trials for its drug, KizaVie. KizaVie, the first drug to address oxygen-starved, or hypoxic, tissues, will be predicted by Phase Advance’s non-linear mathematics model and AI-powered platform for sixteen therapeutic indications including a basket trial for seven cancers. Through this next-generation approach to accelerated drug development, the two teams hope to significantly compress the time for KizaVie to seek regulatory approval. Leaf4Life is also raising funding for future human trials and expects to leverage PAI predictions with investors.
KizaVie’s potential spans several critical disease areas including lung diseases, sepsis, tumors, trauma, shock, mitigation of GLP-1 adverse events, and longevity. Leaf4Life hopes to move the drug to clinical trials, and PAI’s insights to the drug’s performance in each therapeutic application will guide allocation of resources and clinical research towards indications with the highest promise. Optimal dose, dose schedules, optimal duration of therapy, efficacy, biomarker selection, and optimal disease-stage timing are a few of the outcomes that Phase Advance’s in silico trials of virtual patients deliver. Each customized trial simulates thousands of virtual patients’ response rates and varies patients’ genetic background to account for how KizaVie may perform in diverse patient populations. PAI approach has a demonstrated forecasting accuracy of 99.94% when measured versus 29,111 patients’ responses in prospective clinical trials performed months to years after the prediction — the true definition of prediction.
Clet Niyikiza, PhD, CEO of Leaf4Life, comments, “We believe this drug’s broad applications are the exact reason this partnership is so timely. A tool to see into the clinical future enables Leaf4Life to reduce uncertainties and advance programs with the greatest impact on human health.”
“Phase Advance’s models are disease-agnostic, so KizaVie’s many indications are an ideal fit for a platform that offers not just a go/no-go decision, but deep insight into how well the drug will work,” says Dr. Tawanda Gumbo, Phase Advance cofounder and CEO, “and we’re excited to forecast KizaVie’s tremendous therapeutic potential. PAI’s models, which do not use large-language models, are an ideal fit for KizaVie, a new therapeutic class for which no prior data is available for training the model.”
About Phase Advance
Phase Advance layers non-LLM AI modules over cradle-to-grave nonlinear mathematical models of human lifespans. Its models prospectively predicted clinical trial results starting in 2018 for sponsors whose actual trials followed. Over 29,111 human patients’ clinical trial response rates for treatments of several different diseases were within 99.94% of those predicted by Phase Advance. Learn more at www.phaseadvance.ai
About Leaf4Life
Leaf4Life is a biopharmaceutical company dedicated to developing transformative therapies for hypoxia across critical diseases. Their lead product, KizaVie™ (LEAF-4L6715), is a novel liposomal formulation of transcrocetin designed to enhance oxygen diffusion throughout the body. By restoring microcirculatory oxygen delivery, the therapy addresses hypoxia-driven microvascular and tissue damage to improve patient survival. Learn more at www.leafforlife.com
Rachael Sparks
Phase Advance
+1 512-576-4418
rachael.sparks@phaseadvance.ai
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