FDA Puts FibroGen’s Pamrevlumab on Fast Track as IPF Treatment
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FibroGen’s investigational compound pamrevlumab has received fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).
The agency’s decision follows review of the double-blind PRAISE Phase 2b study (NCT01890265) results, which showed that, over 48 weeks, intravenous delivery of 30 mg/kg pamrevlumab halted lung fibrosis (scarring) progression in patients with mild-to-moderate IPF, in comparison to placebo. This correlated with improved lung function, as measured by forced vital capacity.
The trial included a total of 103 patients and also showed that treatment with pamrevlumab was well-tolerated, with no safety risks.
“This Fast Track designation reflects recognition of the great need for a new therapeutic to help patients diagnosed with IPF to reduce the burden and progression of this debilitating disease and another positive step in developing pamrevlumab,” Elias Kouchakji, MD, FibroGen’s senior vice president, clinical development and drug safety, said in a press release.
The FDA grants fast track designation to speed the development and review of potential medications for serious conditions with the aim of filling an unmet medical need. The designation enables more frequent communication with the FDA regarding clinical trials’ designs and collection of all needed data for regulatory approval. Treatment candidates on fast track status also may benefit from accelerated approval and priority review.
“We look forward to advancing pamrevlumab into Phase 3 studies early next year,” Kouchakji added.
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Pamrevlumab is an antibody targeting a specific factor — called connective tissue growth factor (CTGF) — known for its key role in promoting fibrosis and related diseases, including IPF, pancreatic cancer, and Duchenne muscular dystrophy.
Prior preclinical data in a mouse model of IPF show that treatment with pamrevlumab led to lower lung density — suggesting reduced lung fibrosis and remodeling — than with either Esbriet (pirfenidone, by Genentech) or Ofev (nintedanib, by Boehringer Ingelheim), two approved medications for IPF.
Besides IPF, the San Francisco-based company also will test pamrevlumab in Phase 3 stage in pancreatic cancer. The therapy is currently being tested in a Phase 2 study of Duchenne muscular dystrophy (NCT02606136). Pamrevlumab was granted orphan drug designation in both IPF and pancreatic cancer.
In March, the antibody therapy received the FDA’s fast track designation for the treatment of locally advanced unresectable pancreatic cancer.
Terry Schultz
Is there a time line for this
Ric Ellen’s
PBI-4050 is an oral compound designed to prevent inflammation and tissue scarring in several organs, including the lungs, kidneys, liver, heart and pancreas. Prometic is developing it not only as a potential treatment for IPF, but also for Alström syndrome, metabolic syndrome and chronic kidney disease associated with type 2 diabetes. A pivotal trial is one intended to provide evidence for a drug’s regulatory approval.
A 20-week Phase 2 clinical trial (NCT02538536) showed that PBI-4050, alone or in combination with Ofev (nintedanib; Boehringer Ingelheim), slowed IPF patients’ lung function decline and stabilized their breathing capacity.
The Phase 3 trial will cover people with mild to moderate IPF, including some on Ofev and some who are not. Prometic will not enroll patients on Genentech’s Esbriet (pirfenidone) because a drug-drug interaction between Esbriet and PBI-4050 was reported in previous trials.
Using both patients who are on Ofev and patients who are not in the trial will show whether PBI-4050 is effective alone and in combination with Ofev.
Two groups of patients in the year-long trial will receive one of two doses of PBI-4050 — either 800 mg or 1,200 mg. A third group will receive a placebo.
The trial’s primary objective will be to assess PBI-4050’s ability alone, or in combination with Ofev, to slow patients’ annual rate of decline in a measure of lung function known as forced vital capacity. That is the amount of air a person can force from their lungs after taking the deepest breath possible.
Cora Godwin
What would this drug effects be with mycophenolate (Cellcept)? which is the one I am on. I'm also on rituximab which is an infusion every 4 months. It is also for my rheumatoid arthritis.
Michelle Paulsen
I am interested in finding out also.
Michelle Paulsen
I am interested in this also.
John Hamlin
Diagnosed in 2017 with IPF . Mild with slow progression. I would be interested in learning about a trial.
MrMaalox
In your mild progression what has your diffusion been??
Thank you......
Janet
Should look at clinicaltrials.gov
Patricia A Doyle
God bless these very intelligent people that can come up with these meds that helps IPF.
It gives us, who are suffering, hope!!
Clifford Wood
As I have IPF and will start OPEV next week I am very interested in any new drug .
I assume Pulominoligists will write prescriptions .
Any idea as to cost? Any funds available? Injections required ?
Any other pertinent info ?
Steven Dragoo
Very encouraging to read this article. Is there a process to sign up for stage 3 testing?
Thank you,
SteveD
Dania Parisé
NOUS VOULONS essayer le PBI 4050,,,en phase 3.....merci Dania
Sandie
Let us all pray for its quick success. May all our lives be extended due to the honest hard work of our researchers! God Bless them everyone, God bless all those who are ill who are waiting, searching and hoping!
Joyce McCollum
I have IPF and it is progressing. I'm very interested in your Phase 3 Study and am interested in participating.
Donna Malland
The article regarding PBI-4050 are from 2017. Where would I find the most recent development of this drug? I have just recently been diagnosed with IPB so I am very interested in the latest updates and progress with this drug. Thank you
Jopf
Hi All, I am exactly 5 years from preliminary diagnosis. At that time 105% predicted fvc. Now at 82% fvc. I can still funtion at normal levels of daily routine, but as a lifelong runner have been aware of my declining performance levels for some 10 years. Today I can only do 1/4 mile jog before reducing to a walk, hills kill me. Apart from IPF(and declining mental power) I am in great condition for a 76 year old. Yes how do I in the UK get onto a trial?
Elizabeth Renfroe
Please keep me informed. I am on Ofev now, almost two years. Very interested in the new drug, always hoping and praying for a miracle.
Virginia Juárez
Diagnosis with IPF 04/2009. I have taken Imrun, 6MP, Mycophenolate at different time. Medication were stop due to side effects. My physican stated there no other immune medication that I can take. That PF is progressing and is worse .Read the comments and medications that other people take no other medications we offer. I would like to try any trial
Steve Samet
I've been reading the prior comment thread and am unsure why almost all of them refer to Prometic's orally-delivered drug PBI-4050. The subject of the article refers to Fibrogen's drug Pamrevlumab (FG-3019), which is an intravenous (injected) compound. While the Prometic drug will not be administered to Esbriet users, Pamrevlumab does not list any such limitation. I too am inquiring about the possibility of joining a phase 3 study (of Fibrogen's drug because I use Esbriet), and at the same time wish for a successful outcome for those taking part in the Prometic study.
Sandie
I'm in agreement w/you,Steve! Fibrogen and Promedics are two separate companies each striving to develop two different promising medications. May we soon benefit by them. Lets hope & pray Fast Track is accelerated! We need help now, please
Barbara ten Broeke
Will we be fast tracked with "severe" ILD/HP disease. Patient is 88 and willing to live another 10 years. They are trying prednisone and cellcept now. Not on any drugs prior to today. In a clinical trial by Ingelheim/Boeringer to see if Ofev works. We think he is on placebo or it doesn't work for him. Trial is over in April 2019
Rhea Metcalfe
My Mother in law was one of your 103 patients in the 48 week study of Pamrevlumab. This drug was a miracle in completely halting the progression of her Pulmonary Fibrosis. From the moment she started it. Unfortunately she caught a cold during the trial and was taken out of it. She has maintained her results from Pamrevlumab for the year but unfortunately this horrible disease is now Progressing. Is there any type of hope for the patients included in the trial the doctors are now telling her to get her things in order... this is so unfair to know that there is a drug out there like this, witnessing what it can do and now being at the mercy of time. Please help us save her? If there are any types of programs that we could look into or grants could you please let me know. Thank you