Nuvectis Pharma Announces Successful Completion of a Drug-Drug Interaction Study in Healthy Volunteers Supporting NXP900's Potential as a Combination Partner with Leading Therapies
Nuvectis Pharma (NASDAQ: NVCT) has successfully completed a drug-drug interaction (DDI) study for NXP900 in healthy volunteers. The study revealed that NXP900 is classified as a weak inhibitor of CYP3A, supporting its potential combination with EGFR and ALK inhibitors in non-small cell lung cancer (NSCLC) treatment.
The study involved 14 healthy volunteers and showed NXP900 increased Midazolam concentration by less than 2-fold. No serious adverse events were reported, with only mild to moderate diarrhea and non-infection related white blood cell count increases observed.
The company is completing its Phase 1a dose escalation study and plans to advance to Phase 1b testing, which will evaluate NXP900 both as a single agent and in combinations with leading EGFR and ALK drugs in patients whose cancers may be sensitive to SRC/YES1 inhibition.
Nuvectis Pharma (NASDAQ: NVCT) ha completato con successo uno studio sulle interazioni farmacologiche (DDI) di NXP900 in volontari sani. Lo studio ha dimostrato che NXP900 è un debole inibitore del CYP3A, supportando così la sua potenziale combinazione con inibitori di EGFR e ALK nel trattamento del carcinoma polmonare non a piccole cellule (NSCLC).
Lo studio ha coinvolto 14 volontari sani e ha mostrato che NXP900 aumenta la concentrazione di Midazolam meno di due volte. Non sono stati riportati eventi avversi gravi, solo diarrea da lieve a moderata e un aumento dei globuli bianchi non correlato a infezioni.
L'azienda sta completando lo studio di escalation della dose di Fase 1a e prevede di passare alla Fase 1b, che valuterà NXP900 sia come monoterapia sia in combinazione con i principali farmaci EGFR e ALK in pazienti con tumori potenzialmente sensibili all'inibizione di SRC/YES1.
Nuvectis Pharma (NASDAQ: NVCT) ha completado con éxito un estudio de interacción farmacológica (DDI) para NXP900 en voluntarios sanos. El estudio reveló que NXP900 es un inhibidor débil de CYP3A, lo que respalda su potencial combinación con inhibidores de EGFR y ALK en el tratamiento del cáncer de pulmón no microcítico (NSCLC).
El estudio involucró a 14 voluntarios sanos y mostró que NXP900 aumentó la concentración de Midazolam menos de dos veces. No se reportaron eventos adversos graves, solo diarrea leve a moderada y aumentos en el recuento de glóbulos blancos no relacionados con infecciones.
La compañía está completando su estudio de escalada de dosis de Fase 1a y planea avanzar a la Fase 1b, que evaluará NXP900 tanto como agente único como en combinación con los principales medicamentos EGFR y ALK en pacientes cuyos cánceres podrían ser sensibles a la inhibición de SRC/YES1.
Nuvectis Pharma (NASDAQ: NVCT)가 건강한 지원자를 대상으로 NXP900의 약물 상호작용(DDI) 연구를 성공적으로 완료했습니다. 연구 결과 NXP900은 CYP3A의 약한 억제제로 분류되어 비소세포폐암(NSCLC) 치료에서 EGFR 및 ALK 억제제와의 병용 가능성을 뒷받침합니다.
연구에는 14명의 건강한 지원자가 참여했으며, NXP900이 미다졸람 농도를 2배 미만으로 증가시키는 것으로 나타났습니다. 심각한 이상 반응은 보고되지 않았으며, 경미하거나 중등도의 설사와 감염과 무관한 백혈구 수 증가만 관찰되었습니다.
회사는 현재 1a상 용량 증량 연구를 완료 중이며, 1b상 시험으로 진입할 계획입니다. 1b상에서는 NXP900을 단독제 및 SRC/YES1 억제에 민감할 수 있는 환자의 EGFR 및 ALK 주요 약물과의 병용제로 평가할 예정입니다.
Nuvectis Pharma (NASDAQ : NVCT) a mené à bien une étude d’interaction médicamenteuse (DDI) pour NXP900 chez des volontaires sains. L’étude a révélé que NXP900 est un faible inhibiteur du CYP3A, ce qui soutient son potentiel en association avec des inhibiteurs de l’EGFR et de l’ALK dans le traitement du cancer du poumon non à petites cellules (NSCLC).
L’étude a impliqué 14 volontaires sains et a montré que NXP900 augmentait la concentration de Midazolam de moins de deux fois. Aucun événement indésirable grave n’a été rapporté, seuls des cas de diarrhée légère à modérée et une augmentation des globules blancs non liés à une infection ont été observés.
L’entreprise finalise son étude d’escalade de dose de phase 1a et prévoit de passer à la phase 1b, qui évaluera NXP900 à la fois en monothérapie et en association avec les principaux médicaments EGFR et ALK chez des patients dont les cancers pourraient être sensibles à l’inhibition de SRC/YES1.
Nuvectis Pharma (NASDAQ: NVCT) hat erfolgreich eine Studie zu Arzneimittelwechselwirkungen (DDI) mit NXP900 bei gesunden Freiwilligen abgeschlossen. Die Studie zeigte, dass NXP900 als schwacher Inhibitor von CYP3A eingestuft wird, was seine potenzielle Kombination mit EGFR- und ALK-Inhibitoren bei der Behandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) unterstützt.
Die Studie umfasste 14 gesunde Freiwillige und zeigte, dass NXP900 die Midazolam-Konzentration um weniger als das Doppelte erhöhte. Es wurden keine schwerwiegenden Nebenwirkungen gemeldet, lediglich leichte bis mäßige Durchfälle und nicht infektiös bedingte Erhöhungen der weißen Blutkörperchen wurden beobachtet.
Das Unternehmen schließt seine Phase-1a-Dosiseskalationsstudie ab und plant den Übergang zur Phase 1b, in der NXP900 sowohl als Einzelwirkstoff als auch in Kombination mit führenden EGFR- und ALK-Medikamenten bei Patienten getestet wird, deren Tumore möglicherweise empfindlich auf die Hemmung von SRC/YES1 reagieren.
- NXP900 classified as weak CYP3A inhibitor, supporting combination potential with EGFR/ALK inhibitors
- No serious adverse events reported in the DDI study
- Advancement to Phase 1b clinical trials confirmed for the coming weeks
- Mild to moderate adverse events including diarrhea and white blood cell count increases observed
- 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.
Fort Lee, NJ, July 08, 2025 (GLOBE NEWSWIRE) -- 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.
Summary of NXP900 Clinical DDI Study
- 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 < 2-fold, classifying it as a weak inhibitor of CYP3A
- 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.”
About Nuvectis Pharma, Inc.
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.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate”, "believe”, "contemplate”, "could”, "estimate”, "expect”, "intend”, "seek”, "may”, "might”, "plan”, "potential”, "predict”, "project”, "target”, "aim”, "should”, "will”, "would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900, estimates and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements and data regarding the preclinical studies for NXP900 and the Phase 1a data for NXP900 data to date, and the top-line drug-drug interaction study data reported on today, as well as statements regarding NXP900's therapeutic potential as a single agent and in combination with other approved drugs, and the expected timing for the start of the NXP900 Phase 1b program. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in our 1Q 2025 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Company Contact
Ron Bentsur
Chairman, Chief Executive Officer and President
rbentsur@nuvectis.com
Media Relations Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
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