Drug-drug interaction (“DDI”) clinical studies help identify the potential for side effects, or in some cases, reduced therapeutic efficacy, that may be caused by interactions between different drugs.
The market leading epidermal growth factor receptor (“EGFR”) and anaplastic lymphoma kinase (“ALK”) inhibitors for the treatment of non-small cell lung cancer (“NSCLC”) are substrates of the Cytochrome P450 (“CYP”) enzyme CYP3A, and therefore their combination with drugs that are strong inducers of CYP3A is to be avoided, or is contraindicated.
As per the International Council for Harmonization (“ICH”) M12, topline results from the NXP900 DDI clinical study classify NXP900 as a weak inhibitor of CYP3A; these results support the combination strategy of NXP900 with EGFR/ALK Inhibitors in NSCLC and potentially additional combinations.
July 08, 2025 -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the successful completion of a clinical DDI study in healthy volunteers for NXP900, supporting NXP900’s potential as a combination partner with leading therapies.
Key Study Objective: To determine whether NXP900 is an inducer of CYP3A, and if so, to classify its induction as weak, moderate or strong as per ICH M12 guidelines
Study Population: 14 healthy volunteers
Key Pharmacokinetics Result: NXP900 increased the concentration of Midazolam, a known CYP3A sensitive substrate, by Key Safety Results: No serious or severe adverse events were reported in this study; diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “As we’re now completing the dose escalation Phase 1a study of NXP900 in patients with advanced cancers, the data generated to date, including the preclinical and mechanistic data, the clinical safety, pharmacokinetics and pharmacodynamics data, and now the clinical DDI data, strongly support advancing NXP900 into the Phase 1b program, set to begin in the coming weeks. In the Phase 1b we plan to test the therapeutic potential of NXP900 as a single agent and in non-chemotherapy based combinations with leading EGFR and ALK drugs in patients that may derive substantial clinical benefit from treatment with NXP900, as their cancers are expected to be sensitive to inhibition of SRC/YES1.” Mr. Bentsur concluded, “We believe that NXP900’s differentiating properties, mainly the type 1.5 mechanism of action which combines potent and selective inhibition of both the kinase activity and scaffolding properties of the SRC family kinases, should translate into a wide therapeutic window, and we are excited about the future of NXP900.”
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900's unique mechanism of action enables the inhibition of both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.
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