Trial will evaluate the safety, pharmacokinetics and pharmacodynamics of RPT1G in adult healthy volunteers in anticipation of their upcoming oncology trial to treat patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS)
GAITHERSBURG, Md., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Remedy Plan Therapeutics, a privately-held clinical-stage pharmaceutical company transforming the field of NAMPT inhibition, announced today the initiation of an adult healthy volunteer Phase 1 clinical trial of its first-in-class, hyperbolic NAMPT inhibitor, RPT1G. As a hyperbolic NAMPT inhibitor, RPT1G is designed to target cells with high levels of NAMPT that occur in certain cancers, autoimmune and metabolic diseases, while avoiding on-target toxicity and thus preserving biological function in healthy cells.
The Phase 1 randomized, double-blind, placebo-controlled clinical trial of RPT1G is being conducted in adult healthy volunteers in Australia (NCT06667765). The trial will evaluate RPT1G's safety and pharmacokinetic properties while also exploring pharmacodynamic markers. Results from the Phase 1 clinical trial are expected in the first half of 2025 and will accelerate the company's development of its oncology program in AML and high-risk MDS, currently planned to initiate in the second half of 2025.
"We are thrilled to initiate our Phase 1 trial of RPT1G in healthy subjects. RPT1G is not only the first hyperbolic NAMPT inhibitor, but also the first NAMPT inhibitor to be tested in a healthy volunteer study, showcasing the importance of our preclinical work that clearly highlights the favorable safety profile of our hyperbolic NAMPT inhibitors,” stated Greg Crimmins, Ph.D., founder and CEO of Remedy Plan Therapeutics. "The results of this trial will enable us to initiate our subsequent trial in cancer patients at a starting dose that could provide meaningful therapeutic benefit.”
About RPT1G
RPT1G is a novel, small molecule NAMPT inhibitor that is designed to preserve biological function in healthy cells. The favorable efficacy and tolerability profile of RPT1G in preclinical models, compared to previously developed complete NAMPT inhibitors, provides robust support for its utility in treating hematological malignancies and solid tumors. In addition to single agent activity, preclinical studies have demonstrated that RPT1G strongly synergizes with current standard of care drugs and overcomes cancer cell resistance to venetoclax, and may offer improved treatment benefit for leukemia patients. Given the broad scientific validation of NAMPT upregulation in autoimmune and metabolic diseases, RPT1G analogues are also being evaluated as potential therapies for those diseases.
About Remedy Plan Therapeutics
Remedy Plan Therapeutics is a privately-held, clinical-stage pharmaceutical company transforming the field of NAMPT inhibition. Remedy Plan's lead asset, RPT1G, is the first hyperbolic NAMPT inhibitor to be tested in humans and has potential for broad therapeutic applications in cancer, autoimmune and metabolic diseases. Remedy Plan initiated a Phase 1 clinical trial of RPT1G in adult healthy subjects in November 2024. To learn more about Remedy Plan, please visit https://remedyplan.com/.
Investor Relations and Media Contact:
Parisa Moghaddam-Taaheri
press@remedyplan.com