Galapagos Launches Global ISABELA Program Testing GLPG1690 in IPF Patients
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Galapagos has started the worldwide ISABELA Phase 3 program to evaluate the potential of GLPG1690 as a treatment for idiopathic pulmonary fibrosis (IPF), reporting that the first participant has already been treated.
GLPG1690 inhibits autotaxin, an enzyme that is thought to be involved in tissue scarring (fibrosis) and IPF progression. The U.S. Food and Drug Administration and the European Commission granted orphan drug designation to GLPG1690 as a treatment for IPF.
The global program consists of two identically designed trials, called ISABELA 1 (NCT03711162) and ISABELA 2 (NCT03733444). Together, they are expected to enroll a total of 1,500 patients, of 40 years of age or older, who have received an IPF diagnosis within 5 years of starting the trials.
More than 200 clinical sites worldwide will be involved in the program, including several centers located in the United States and Europe. During the studies, patients will be randomized to receive one of two doses of GLPG1690 or a placebo, in addition to their IPF standard of care treatment.
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All patients will continue the assigned treatment until the last patient in each of the studies has completed 52 weeks of treatment. This means that some patients will be followed for substantially more time than the minimum 52 weeks. This particular trial design will allow researchers to have a broader assessment of less frequent treatment-related adverse events that otherwise could be difficult to detect with one-year standard clinical studies.
Researchers will evaluate the efficacy of GLPG1690 to improve patients’ lung function compared with the placebo, as determined by the rate of decline in forced vital capacity (FVC). They will also evaluate changes in disease progression, frequency of respiratory-related hospitalizations, quality of life, and mortality.
For more information about the trials and how to participate, visit the program webpage here.
The launch of the ISABELA program “demonstrates our commitment to the rapid advancement of our IPF franchise,” Walid Abi-Saab, MD, chief medical officer at Galapagos, said in a press release. “We are excited by the feedback received from participating sites and key opinion leaders, which underscores the need for novel treatments to address the remaining high unmet need in IPF.”
Previous results from the Phase 2 FLORA trial (NCT02738801) showed that a daily 600 mg dose of GLPG1690 resulted in an improvement in FVC at 12 weeks in IPF patients, and that the treatment was well-tolerated, with most side effects being mild to moderate.
At the end of October, Galapagos announced the start of another clinical study in IPF patients, the Phase 2 PINTA study (NCT03725852) that tests another GPR84 inhibitor called GLPG1205. Still recruiting, this study will assess the potential of the company’s new therapy in addition to standard treatments, such as Esbriet (pirfenidone) or Ofev (nintedanib), for 26 weeks in up to 60 IPF patients.
James Dawson
I have been diagnosed 2 years ago with PF. I have been taken off of Ofev after using only for 2 months, 150 mg and put on Prednisone, 10 Mg. I am a veteran so I go to the VA Hospital in Kansas City. I don't know if a trial would be acceptable to them, but if possible, I would like to be considered. Less than a month ago I had a bronchoscopy sample taken from the lungs. Doctor Plautz, VA Pulmonary said, "not remarkable discovered." Without oxygen, walking will drop it down to 80. With oxygen I can stay at 94 using 5 liters. They don't say IPF, just PF. I am 71 years old.
Koester Janis
I am a 71 year old female diagnosed with IPF almost exactly 3 years ago in Milwaukee, WI, confirmed in Denver at National Jewish Hospital and at UW Hospital in Madison, WI. I am on Ofev and very interested. I am not yet on oxygen.
Jana Tucker
I am a 67 year old female diagnosed with IPF in May 2014 and currently takin Esbriet 801mg t.i.d. I am very interested in participating in this study. Can you provide contact information.
Charles Harrison
Been an IPF sufferer since April 8 th 2016 , would love to try this .on 02 24-7
Jodi Gienow
I am 57 years old women recently diagnosed with IPF and otherwise good health. I am interested in being invoved with the trail. Presently taking Ofev
Travis Calliou
Diagnosed 4 year's ago, 56 year old male, still in mild stage, no oxygen yet. Is this available in Canada????
yoram
prometic life bioscience
company from Canada they do have other "cure" name is PBI4050
https://www.prometic.com/
because you from canada maibe you can paricipate
hope you feel better pal
wade dufrene
My husband 69 years old soon to be 70 at the end of this month.He has been diagnosed with IPF about 2.5 years ago and has been on Ofev for 2 years but the lesser dose of 100 instead of 150. Could not tolerate the 150 but can tolerate the 100 without much problems. He is on oxygen and finds with exertion he needs to use it. He is also going to the VA and testing for a lung transplant but we feel he may be too old and may have some problems that would eliminate him from the transplant and are looking for other options to combat this disease. We live less than 50 miles from a location and would like to know about this study.Could you please let us know if he would possibly be eligible for this trial. This is the first trial that is this close to us and we would be able to stay close to family during this process.
Bill Root
Read with interest your comment regarding your husband's transplant with the VA. Please see the attached website. I have some information I'd like to share with you.
http://www.cbs8.com/story/39352946/va-denies-lifesaving-lung-transplant-for-alpine-veteran
tony ruberti
i am def.ready for a trial with ISABELLAplease call me 904-543-1533 thank you.
Heleanna
Goodmorning everybody.
Could you please tell how many people were enrolled in phase 2 of Isabela? And do you know how many people are usually enrolled in phase 2 trials?
wade dufrene
I am concerned that this may be the same situation as we have been doing test for this transplant for over 6 months. We finish one test then a month later we need another test as he gets closer and closer to the maxed out age. That is why I would like to know more about this trial.
Jim Hackett
I am a 68 year old male living in Canada. I was diagnosed with IPF in July 2016. I was on Ofev 150 for 2 years but due to side effects my dosage was reduced to Ofev 100 for the past 5 months. Definitely more manageable from a side effects perspective. I have been doing regular breathing tests and six minute walks for the past 2.5 years and have been told that my condition remains stable. I am not yet using oxygen. I would be very interested in participating in the Isabella phase 3 trial when it comes to the Toronto area.
John W Ford
Has anyone had any experience with Lung Health Institute headquartered in Tampa Florida on Lung restoration with cellular therapy
They post great results
Bernard Sullivan
I am a 66 year old man being treated at Shand Medical Center at the University of Florida in Gainsville. I have been diagnosed with IPF and take OFEV. I do not use oxygen. I am interested in this program.
Joseph Pelletier
Please sign me up for the trial.
On ofev 150 x 2 daily for the last 6 months and using oxygen 24/7.
Geoff PARKER
I have been diagnosed with IPF, a 68 yr old male. Can you advise which hospital in Australia is participating in this trial.
Richard Phillips
I am a 73 year old male dx 2 and 1/2 years ago, currently on 150 ofev no major problems taking. My lung Dr is at Va here in Gainesville Fl, also seeing transplant team at Shands
At University of Florida. I am interest in the study.n/a
Décio Tavares Soares
Meu nome é Décio Soares e resido em Ouro Preto, Minas Gerais , Brasil. Tenho fibrose Pulmonar Idiopática diagnosticada há mais ou menos três anos. Usei o Ofev por alguns meses, mas não tolerei devido aos efeitos colaterais. Hoje estou em uso do Esbriet , com tolerância razoável. Minhã função respiratória permanece mais ou menos estável e, não uso oxigênio. Algum pneumologista em Belo Horizonte está participando dos testes com o GLPG 1630?
Agradeço a atenção
Alice Melão, MSc
Olá Décio,
Nesta pagina de web https://clinicaltrials.gov/ct2/results?cond=pulmonary+fibrosis&term=&cntry=BR&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=d pode encontrar os ensaios clinicos para fibrose pulmonar que estão de momento a recrutar no Brasil. Alterando os elementos da pesquisa pode filtrar a informação que procura.
Espero que esta informação lhe seja útil.
Jack
I am 38 yrs old and diagnosed for ipf 1 month ago
My symptoms is only dry cough,without shortness of breathing
My ct is just glass wound without honeycombing
My fvc fev1 is around 100
I am not ready to start the ofev treatment
I have few questions:
1. This medicine can stop ipf scarring instead of slow down the process like other medicine eg.ofev?
2.For my situation, can I join the following scheme
Edwardo Aguilar
"...all im going to say is...N115 non steroidal nasal spray!...spoke to the president of the company and he confirmed they have it ready to go all bottled up ,they applied for marketing through the FDA ,phase 3/phase 4,..all good signs, no side effects, works wonders
by the numbers,..but...here we are still!... its called Emphycorp . com ..all the info is there about n115
http://pulmonaryfibrosisnews.com/2019/08/19/n115-completes-trial-fda-marketing-application-pf-patients/?unapproved=28059&moderation-hash=6e97422c5586c6d6ac90695e99ab8aa9#comment-28059
thin thin aye
My sister who lives in Burma suffers from IPF
She is on Pirenidone. How can she buy the drug?