Vertex Highlights First Oral Presentation of Phase 3 Clinical Data of the Vanza Triple and New Data on Long-Term Impact of TRIKAFTA® at the North American Cystic Fibrosis Conference
Vertex Pharmaceuticals (Nasdaq: VRTX) announced the first oral presentation of Phase 3 data on their investigational vanzacaftor/tezacaftor/deutivacaftor (vanza triple) at the North American Cystic Fibrosis Conference (NACFC). The vanza triple demonstrated non-inferiority to TRIKAFTA® in ppFEV1 and further improvement in CFTR function as measured by sweat chloride. Vertex also presented data showing sustained long-term benefits of TRIKAFTA®, including improvement in pancreatic function in young patients.
The vanza triple has been submitted for regulatory approval in multiple countries, with an FDA PDUFA date of January 2, 2025. New data on TRIKAFTA® from long-term studies in patients ages 2-11 years old showed sustained improvements in lung function and potential improvement in exocrine pancreatic function over time.
Vertex Pharmaceuticals (Nasdaq: VRTX) ha annunciato la prima presentazione orale dei dati di Fase 3 sul loro farmaco in fase di studio vanzacaftor/tezacaftor/deutivacaftor (triple vanza) durante la Conferenza Nordamericana sulla Fibrosi Cistica (NACFC). La triple vanza ha dimostrato non inferiorità rispetto a TRIKAFTA® in ppFEV1 e ulteriori miglioramenti nella funzione del CFTR misurati tramite il cloruro di sudore. Vertex ha anche presentato dati che mostrano benefici a lungo termine sostenuti di TRIKAFTA®, inclusi miglioramenti nella funzione pancreatica nei giovani pazienti.
La triple vanza è stata sottoposta per approvazione normativa in più paesi, con una data PDUFA della FDA fissata per 2 gennaio 2025. Nuovi dati su TRIKAFTA® provenienti da studi a lungo termine su pazienti di età compresa tra 2 e 11 anni hanno mostrato miglioramenti sostenuti nella funzione polmonare e potenziale miglioramento della funzione pancreatica esocrina nel tempo.
Vertex Pharmaceuticals (Nasdaq: VRTX) anunció la primera presentación oral de los datos de Fase 3 sobre su tratamiento en investigación vanzacaftor/tezacaftor/deutivacaftor (triple vanza) en la Conferencia Norteamericana sobre Fibrosis Quística (NACFC). La triple vanza demostró no inferioridad a TRIKAFTA® en ppFEV1 y una mejora adicional en la función del CFTR medida a través del cloruro en sudor. Vertex también presentó datos que muestran beneficios a largo plazo sostenidos de TRIKAFTA®, incluyendo mejoras en la función pancreática en pacientes jóvenes.
La triple vanza ha sido sometida para aprobación regulatoria en múltiples países, con una fecha PDUFA de la FDA el 2 de enero de 2025. Nuevos datos sobre TRIKAFTA® de estudios a largo plazo en pacientes de entre 2 a 11 años mostraron mejoras sostenidas en la función pulmonar y un posible mejora en la función pancreática exocrina con el tiempo.
Vertex Pharmaceuticals (Nasdaq: VRTX)는 북미 낭포성 섬유증 회의(NACFC)에서 연구 중인 vanzacaftor/tezacaftor/deutivacaftor (삼중 반자)의 3상 데이터에 대한 최초의 구두 발표를 발표했습니다. 삼중 반자는 ppFEV1에서 TRIKAFTA®와의 비열등성을 입증했으며, 땀의 염소 농도로 측정된 CFTR 기능의 추가 개선을 나타냈습니다. Vertex는 또한 젊은 환자에서 TRIKAFTA®의 지속적인 장기적 혜택을 보여주는 데이터를 발표했습니다.
삼중 반자는 여러 국가에서 규제 승인을 요청했으며, FDA의 PDUFA 날짜는 2025년 1월 2일로 설정되었습니다. 2세에서 11세 사이의 환자에 대한 장기 연구에서 얻은 TRIKAFTA®에 대한 새로운 데이터는 폐 기능의 지속적인 개선과 시간이 지남에 따라 외분비 췌장 기능의 잠재적 개선을 보여주었습니다.
Vertex Pharmaceuticals (Nasdaq: VRTX) a annoncé la première présentation orale des données de Phase 3 sur leur médicament expérimental vanzacaftor/tezacaftor/deutivacaftor (triple vanza) lors de la Conférence Nord-Américaine sur la Fibrose Kystique (NACFC). La triple vanza a démontré une non-infériorité par rapport à TRIKAFTA® en ppFEV1 et une amélioration supplémentaire de la fonction CFTR mesurée par le chlore dans la sueur. Vertex a également présenté des données montrant des bénéfices à long terme soutenus de TRIKAFTA®, y compris une amélioration de la fonction pancréatique chez les jeunes patients.
La triple vanza a été soumise pour approbation réglementaire dans plusieurs pays, avec une date PDUFA de la FDA prévue pour le 2 janvier 2025. De nouvelles données sur TRIKAFTA® issues d'études à long terme chez des patients âgés de 2 à 11 ans ont montré des améliorations durables de la fonction pulmonaire et un potentiel d'amélioration de la fonction pancréatique exocrine dans le temps.
Vertex Pharmaceuticals (Nasdaq: VRTX) hat die erste mündliche Präsentation von Phase-3-Daten zu ihrem Prüfpräparat vanzacaftor/tezacaftor/deutivacaftor (vanzatriple) auf der Nordamerikanischen Mukoviszidose-Konferenz (NACFC) angekündigt. Die Vanzatriple hat Nicht-Unterlegenheit gegenüber TRIKAFTA® im ppFEV1 und eine weitere Verbesserung der CFTR-Funktion gemessen am Chlorid im Schweiß gezeigt. Vertex präsentierte auch Daten, die langfristige, nachhaltige Vorteile von TRIKAFTA® zeigen, einschließlich Verbesserungen der pankreatischen Funktion bei jungen Patienten.
Die Vanzatriple wurde in mehreren Ländern zur regulatorischen Genehmigung eingereicht, mit einem PDUFA-Datum der FDA am 2. Januar 2025. Neue Daten zu TRIKAFTA® aus Langzeitstudien bei Patienten im Alter von 2 bis 11 Jahren zeigten nachhaltige Verbesserungen der Lungenfunktion und potenzielle Verbesserungen der exokrinen pankreatischen Funktion im Laufe der Zeit.
- Phase 3 data shows vanza triple is non-inferior to TRIKAFTA® in ppFEV1
- Vanza triple demonstrates further improvement in CFTR function (sweat chloride)
- Regulatory submissions made globally for vanza triple
- FDA assigned PDUFA date of January 2, 2025 for vanza triple
- Long-term TRIKAFTA® studies show sustained improvements in lung function
- TRIKAFTA® potentially improves exocrine pancreatic function in young children
- None.
Insights
The Phase 3 data on Vertex's investigational vanza triple combination therapy is highly significant for CF treatment. Key points:
- Demonstrated non-inferiority to TRIKAFTA in lung function (ppFEV1)
- Showed further improvement in CFTR function via sweat chloride levels
- Potential for once-daily dosing, improving convenience
- Regulatory submissions made globally for ages 6+
- FDA PDUFA date set for January 2, 2025
This represents a potential next-generation therapy that could surpass TRIKAFTA in efficacy. The additional reduction in sweat chloride suggests improved CFTR function, which may translate to better long-term outcomes. For investors, this pipeline progress is important as Vertex aims to maintain its dominance in CF treatment.
This news is highly positive for Vertex's market position and future revenue potential:
- Vanza triple could extend Vertex's CF franchise leadership beyond TRIKAFTA
- Global regulatory submissions indicate potential for near-term revenue expansion
- Once-daily dosing may improve patient compliance and market penetration
- Long-term TRIKAFTA data reinforces the durability of Vertex's current CF portfolio
The sustained benefits in younger patients are particularly noteworthy, as early treatment could lead to increased lifetime value per patient. With a market cap of
– Phase 3 data on investigational vanza triple demonstrates non-inferiority to TRIKAFTA® in ppFEV1 and further improvement of CFTR function as measured by sweat chloride –
– Real-world evidence and clinical studies of TRIKAFTA® continue to show sustained long-term benefits including improvement in pancreatic function in young patients –
“TRIKAFTA has transformed the treatment of CF in the 5 years since its approval, changing the outlook for patients with CF,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “Toward our goal to bring all eligible patients to normal levels of CFTR function, we have made global regulatory submissions for our next-in-class vanza triple combination medicine for patients with CF aged 6 years and older. We are excited to bring this promising new medicine, which has the potential to deliver even greater improvements in sweat chloride, to patients with CF.”
Data on the Investigational Once Daily Next-in-Class Triple Combination Therapy, vanzacaftor/tezacaftor/deutivacaftor
Vertex will present data on the vanza triple in an oral presentation and two posters on Friday, September 27. This is the first time that the clinical data from the Phase 3 clinical trials of the vanza triple in patients 6 years and older with CF have been accepted for presentation at a medical meeting. These data formed the basis of global regulatory submissions.
“The additional, significant reductions in sweat chloride we see in the vanza triple clinical trials are noteworthy. I believe this improvement in CFTR function may lead to important benefits for people with CF,” said Claire L. Keating, M.D., Co-Director of the Gunnar Esiason Adult Cystic Fibrosis and Lung Program at Columbia University. “If approved, as a clinician, I’m looking forward to being able to offer patients an option, with once daily dosing, that could advance the treatment for people living with CF.”
Data from the Phase 3 clinical studies of the vanza triple will be presented in the following sessions:
- “Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ Triple) in Adolescents and Adults with CF: Results from Two Randomized, Active-Controlled Phase 3 Trials,” will be an oral presentation during a session entitled: “Cutting Edge Research: What’s New” on Friday, September 27, from 10:15 a.m. to 12:15 p.m. EDT and be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT.
- “Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ Triple) in Children 6 Through 11 Years of Age with Cystic Fibrosis,” will be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT.
The vanza triple was granted Fast Track and Orphan Drug Designations from the
Long-Term Benefits of TRIKAFTA®
Vertex will present new data on TRIKAFTA® from long-term (96 week and 192 week) studies in patients ages 2-11 years old that reinforce the sustained benefit seen in studies in older people with CF. Specifically, that early treatment with TRIKAFTA® is associated with sustained improvements in lung function. These new data demonstrate that in these young children, TRIKAFTA® could also lead to improved exocrine pancreatic function over time. The data presented at NACFC highlight the safety and tolerability of TRIKAFTA®, which were generally consistent with the established safety profile.
“I have seen first-hand the positive long-term impact that improvement of CFTR function by TRIKAFTA can have on patients’ clinical outcomes. These improvements are particularly striking for me as a physician caring for young children, where improvements in things like lung function, pancreatic function and quality of life are so meaningful,” said Professor Marcus A. Mall, M.D., Professor and Chair of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine and Cystic Fibrosis Center at Charité - Universitätsmedizin
Vertex will have four poster presentations that include clinical trial and real-world evidence data, three specifically on TRIKAFTA® and one showing sustained benefits from KALYDECO®, which is approved for treatment in the youngest ages.
- “Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in children 2 years and older with cystic fibrosis and at least one F508del allele: 96-week results from an open-label extension study,” will be a poster presentation on Friday, September 27, at 12:15-1:15 p.m. EDT.
- “Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in children 6 years and older with cystic fibrosis and at least one F508del allele: Results from a 192-week extension study,” will be a poster presentation on Friday, September 27, at 1:15-2:15 p.m. EDT.
- “Effectiveness of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in people with cystic fibrosis and non-F508del CFTR variants: Interim results from a registry-based study,” will be a poster presentation on Friday, September 27, from 12:15-1:15 p.m. EDT.
- “Long-term benefits of early ivacaftor (IVA) initiation in people with cystic fibrosis (CF),” will be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT.
About Cystic Fibrosis
Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving.
Learn more about the importance of sweat chloride (SwCl) in cystic fibrosis.
Today Vertex CF medicines are treating over 68,000 people with CF across more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy.
About vanzacaftor/tezacaftor/deutivacaftor (the “vanza triple”)
In people with CF, mutations in the CFTR gene lead to decreased quantity and/or function of the CFTR protein channel at the cell surface. Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein at the cell surface by facilitating the processing and trafficking of the CFTR protein. Deutivacaftor is a potentiator designed to increase the channel open probability of the CFTR protein delivered to the cell surface to improve the flow of salt and water across the cell membrane.
Investigational vanzacaftor/tezacaftor/deutivacaftor was granted Fast Track and Orphan Drug Designations from the
About TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways.
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation, or another mutation responsive to TRIKAFTA®, in the CFTR gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA® is safe and effective in children under 2 years of age.
TRIKAFTA
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age.
IMPORTANT SAFETY INFORMATION
Before taking TRIKAFTA, patients should tell their doctor about all of their medical conditions, including if they: are allergic to TRIKAFTA or any ingredients in TRIKAFTA, have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant because it is not known if TRIKAFTA will harm an unborn baby, or are breastfeeding or planning to breastfeed because it is not known if TRIKAFTA passes into breast milk.
Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin.
Patients should avoid food or drink that contains grapefruit while taking TRIKAFTA.
TRIKAFTA can cause serious side effects, including:
Liver damage and worsening of liver function in patients with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in patients without liver disease.
High liver enzymes in the blood, which is a common side effect in patients treated with TRIKAFTA. These can be serious and may be a sign of liver injury. The patient’s doctor will do blood tests to check their liver before they start TRIKAFTA, every 3 months during the first year of taking TRIKAFTA, and every year while taking TRIKAFTA. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.
Serious allergic reactions have happened to patients who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips and/or tongue; difficulty swallowing; and light-headedness or dizziness.
Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.
The most common side effects of TRIKAFTA include headache, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, diarrhea, rash, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, flu (influenza), inflamed sinuses, and increase in blood bilirubin.
Patients should tell their doctor if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of TRIKAFTA. For more information, patients should ask their doctor or pharmacist.
Please click here to see the full
KALYDECO®
INDICATIONS AND USAGE
KALYDECO (ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 1 month and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 1 month of age.
IMPORTANT SAFETY INFORMATION
Before taking KALYDECO, patients should tell their doctor about all their medical conditions, including if they: have liver or kidney problems; are allergic to KALYDECO or any ingredients; are pregnant or plan to become pregnant because it is not known if KALYDECO will harm an unborn baby; and are breastfeeding or planning to breastfeed because is not known if KALYDECO passes into breast milk.
Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take the antibiotics rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin.
KALYDECO can cause dizziness in some patients who take it. If patients experience dizziness, they should not drive or operate machines until symptoms improve.
Patients should avoid food or drink containing grapefruit while taking KALYDECO.
KALYDECO can cause serious side effects including:
High liver enzymes in the blood, which have happened in patients receiving KALYDECO. The patient’s doctor will do blood tests to check their liver before starting KALYDECO, every 3 months during the first year of taking KALYDECO, and every year while taking KALYDECO. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber-colored urine.
Serious allergic reactions have happened to patients who are treated with KALYDECO. Patients should call their healthcare provider or go to the emergency room right away if they have symptoms of an allergic reaction. Symptoms of an allergic reaction may include rash or hives, tightness of the chest or throat or difficulty breathing, and light-headedness or dizziness.
Abnormality of the eye lens (cataract), which has happened in some children and adolescents receiving KALYDECO. The patient’s doctor should perform eye examinations before and during treatment with KALYDECO to look for cataracts.
The most common side effects include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.
Use of KALYDECO in patients aged 1 month to less than 6 months born from a pregnancy lasting (gestational age) less than 37 weeks has not been evaluated.
These are not all the possible side effects of KALYDECO. Please click here to see the full Prescribing Information for KALYDECO.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.
Vertex was founded in 1989 and has its global headquarters in
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements by Carmen Bozic, M.D., Professor Marcus A. Mall, M.D., and Claire L. Keating, M.D., in this press release, and statements regarding our expectations for and the anticipated benefits of the vanza triple, our expectations that medical presentations of Phase 3 data on the vanza triple will take place at NACFC, our expectations for the long-term data for TRIKAFTA, plans to present long-term TRIKAFTA data and KALYDECO data, and our expectations for a lower royalty obligation for the vanza triple. While we believe the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, and other reasons, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company's website at www.vrtx.com. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
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FAQ
What are the key findings of the Phase 3 vanza triple trials for VRTX?
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What long-term benefits of TRIKAFTA® were presented by Vertex (VRTX) at NACFC?
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