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Boehringer Ingelheim 1015550 fibroneer study
I have been in this phase 3 study for a year and 2 weeks ago actually started receiving the drug after it was approved for compassionate use. Wondering if anyone else is receiving this and if you have noticed any side effects?
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19 Replies
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I am very interested in this product and hope it is available soon. Please let me know if you have any information, please.
Thanks,
Mack
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My husband has been on OFEV for 11 years. He is so fortunate he’s had no side affects. We are really looking forward to this fibro drug being approved by fda. The patent is coming up for ofev so, I’m not surprised they have another drug in the forefront. My husband has had violent cough off and on for the 11 years. He’s tried all the standard prescription meds , syrups etc. anyone have suggestions or has anyone tried red light therapy.
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I too have dealt with a horrible cough for 4 years or so, along with extreme shortness of breath (SOB) which limited my ability to move around. My pulmonologist prescribed many meds and over-the-counter products, none of which had any effect. About a month ago she recommended I try a very low dose of oxycodone (5mg 2X/day) and it has been a game changer for both my SOB and cough. Oxycodone is used in palliative care for SOB, but it also greatly relieves my cough. My pulmonologist said at this low dose, addiction is not really an issue. I resisted it for months because it is a narcotic, but finally decided to give it a try since nothing else works. I feel like I got my life back, or at least my life with chronic pulmonary fibrosis without these conditions weighing me down. I’m not sure that many pulmonologists would prescribe it since it is narcotic, but if they are concerned with quality of life perhaps they would be willing to let your husband give it a try if he requests it.
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I was in this Phase 3 study of what was called BI1015550 for a year at Brigham and Women’s Hospital in Boston. My PFTs remained remarkably stable during that year with only a small decline. After the study year finished and we were allowed to continue on the real drug for up to another two years, I was told that I had actually been on the placebo rather than the real drug during the first study year. I must have been an unusual case because Boehringer Ingelheim’s results showed that those on the real drug on average fared significantly better (less decline in PFTs) than those on the placebo. On the real drug, now called nerandomilast, I have more upset stomach symptoms but nothing that disturbs my way of life. I I have wondered whether my lifestyle choices (losing weight, walking 5 miles a day, reducing stress, sleeping better, eating healthier, having a positive attitude) contributed to keeping my PFTs stable. Has anyone experienced the same thing?
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my wife has the same results. she does not walk as much but, she does a lot of house chores, and still run our businesess, does weight lifting 2 times a week and she lost some weight, she is very fit and like you very possitive . her pft has not change in 1 year and her spo2 actually improved, she takes no drugs only1 liter of mullain tea every day.
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I had been in the study for about 18 months when in December they ended phase two and started phase three. I found out that I had been on a half dose, 9 mg per day, and was now going to start on the full dose of 18 mg per day. I had experienced no additional symptoms on the half dose but the full dose was hard on me, stomach and bowel issues but more so a general feeling of fatigue and malaise. It was bad enough that I informed them that I was going to drop out of the study unless they put me back on 9 mg per day. It turns out that enough of us were having difficulty with the full dose that Boehringer were putting everyone on the 9 mg dose and I will be picking up my new prescription on Monday, ahead of the normally scheduled visit. As far as the drug’s impact on me, my disease has remained stable since starting it.
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I’m also very interested in this new drug. It’s my understanding that compassionate (extended) use is only for people that participated in their trial. Does anyone know if that’s true? I was doing the Beacon trial that was cancelled for safety reasons. It was my first experience in a trial
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What were your results in the trial and post? Thanks…
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Hi Steve.
I have extensible reading about it and using ai for more comparable information.
As far as I now, it improve fvc in 12 weeks based on phase 2. Meaning it increases fvc +5.7 comparable with placebo- 87.
They claim to achieve fvc objectives of total change. They didn’t say anything about exacerbation or hospitalization.
By end of June we should see all the results, but, is well noted that they submitted the application to the fda for approval.
If is as they claim, in deed is a game changer.
I m also reading a lot on 2 more promising drugs
Insilico phase 2v and bristol myers phase 3.
Both also very promising, but bi10155 0. Is the first one in 10 years making phase 3 and going for application.
All the best 👍
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Thanks a lot Alex. Good insights. I’ve been on this platform (PF News) since mid-2018…
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Hy Steve, please keep us posted about any news you come across concerning this new drug.
Thanks,
Mack
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Wll do. I was offered a slot in phase 2 of the Boheinger but out of the country at the time so missed it…
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hi Mack: please read the final results https://www.fiercebiotech.com/biotech/not-game-changing-boehringers-phase-3-lung-data-get-muted-response-analysts.
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I have been in the phase 3 study for about a year and a half or so until phase 3 ended around October 2024 and moved into phase 4 red label. That is where you actually get the drug until its FDA approved and is part of the study phase 4. I have had good success. During phase 3 I was stable with my numbers. I don’t know if I was on a placebo or the real drug during the study. I have not had any side effects during phase 3 or in phase 4. The docs call this drug a game changer –
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Hi Friends, I have been a member of this forum for 18 months now. This is my first post. Cheers to all of you who have made it through phase 3 of this trial. The results sound impressive. I too was cleared to begin the Beacon Trial but it was cancelled before I began. I am now scheduled to screen for the phase 3 Bristol-Meyers Aloft Trial. Has anyone participated in either of the first 2 phases of this trial? Anyone participating in this Phase 3? I am a little anxious about this trial as it seems quite cumbersome and a significant commitment, but I am determined to make the best of it. I have been on Esbriet for about 2 1/2 years. I am fortunate not to have debilitating side effects from it. My PFTs have been slowly declining over these last 2 1/2 years, but it wasn’t until December when the decline was much more drastic. I am hopeful that one of these new drugs will stop this insidious disease in its tracks. Best of luck and blessings to you all.
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I just started the Aloft trial last week. I’ve been on Pirfenidone for about five months. So far, no side effects from the Aloft trial drug but they start with a low dose.
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This is are the final findings of how the new drug work. Not as good as i whought but improved fvc and sideeffecMay 19, 2025
5 min read
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<i data-save-icon=”icon” aria-hidden=”true”>Nerandomilast reduces FVC decline, has ‘manageable’ adverse events in IPF at 52 weeks
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Key takeaways:
- Two differing nerandomilast doses were assessed against placebo.
- Both groups had significantly smaller degrees of FVC decline vs. placebo.
- A greater proportion of patients receiving nerandomilast had diarrhea.
SAN FRANCISCO — Two doses of 52-week nerandomilast, a phosphodiesterase 4B inhibitor, reduced FVC decline vs. placebo in patients with idiopathic pulmonary fibrosis, according to results published in The New England Journal of Medicine.
These data on oral nerandomilast (BI 1015550, Boehringer Ingelheim) were simultaneously presented at the American Thoracic Society International Conference.
“I think, personally, that these results really are a major step forward,” Marlies S. Wijsenbeek, MD, of the Center of Expertise for Interstitial Lung Diseases in the department of respiratory medicine at the Erasmus MC University Medical Centre, said during her ATS presentation. “After a decade of failed phase 3 trials, we have now a positive trial, which is really important to the treatment of people with IPF.”
In the multicenter, double-blind, randomized, placebo-controlled phase 3 FIBRONEER-IPF trial, Wijsenbeek and colleagues assessed 1,177 adults aged 40 years or older (mean age, 70.2 years; 83% men; mean FVC, 78.2% predicted) with IPF (mean time since diagnosis, 3.5 years) to determine the impact of two different twice-daily doses of oral nerandomilast vs. placebo on FVC after 52 weeks of treatment.
Healio previously reported on topline results from this trial in September 2024.
Within this set of patients, use of background antifibrotic therapy at enrollment was common, as 77.7% (n = 915) reported nintedanib (n = 535) or pirfenidone (n = 380) use. Wijsenbeek highlighted during her presentation that those with vs. without background use of nintedanib/pirfenidone had a lower FVC (77.1% predicted vs. 82.2% predicted) and more time since diagnosis (3.7 years vs. 2.8 years) at baseline.
The 18 mg nerandomilast group included 392 patients (mean age, 70.3 years; 82.4% men; mean FVC, 78.4% predicted), the 9 mg nerandomilast group included 392 patients (mean age, 70.5 years; 80.9% men; mean FVC, 79% predicted) and the placebo group included 393 patients (mean age, 69.9 years; 85.8% men; mean FVC, 77.3% predicted).
Results
Between baseline and week 52, researchers observed that patients receiving 18 mg nerandomilast had a significantly smaller degree of FVC decline vs. patients receiving placebo (adjusted mean change, –114.7 mL vs. –183.5 mL; adjusted difference, 68.8 mL; 95% CI, 30.3-107.4; P < .001).
Similarly, a significantly smaller FVC reduction was found in those receiving 9 mg nerandomilast vs. placebo (–138.6 mL vs. –183.5 mL; adjusted difference, 44.9 mL; 95% CI, 6.4-83.3; P = .02), according to the study.
“If you look at these data over time, you see that the curves already very early split, and that they continue to diverge over the trajectory over time, which is very encouraging,” Wijsenbeek said. “And you even see that better if you have longer follow-up to 76 weeks.”
Researchers continued to report less FVC decline with both nerandomilast doses by week 52 in the subgroup of patients who did not use background antifibrotic therapy. In the 18 mg and 9 mg nerandomilast groups, FVC went down by 79.2 mL and 70.4 mL, respectively, whereas this measure of lung function dropped by 148.7 mL in the placebo group.
This pattern also held true in the subgroup of patients who used nintedanib, with smaller FVC reductions in those receiving nerandomilast vs. placebo (18 mg, –118.5 mL; 9 mg, –130.7 mL vs. –191.6 mL).
“It’s important to realize that despite that these patients are on an effective drug, they still have this decline, so this illustrates that we really need additional drugs,” Wijsenbeek said.
Patients in the pirfenidone subgroup receiving 18 mg nerandomilast also had a smaller degree of FVC decline between baseline and week 52 vs. patients receiving placebo (–133.7 mL vs. –197 mL), but this was not the case when researchers compared the 9 mg nerandomilast group with the placebo group (–201.8 mL vs. –197 mL).
“We think that the reason for this lack of effect with pirfenidone is probably in the plasma concentrations,” Wijsenbeek said.
“[With] pirfenidone … the plasma concentration levels of nerandomilast are about 50% of what they are in the nintedanib and no background group, so we believe that that explains it,” she continued.
In addition to changes in FVC, the study captured changes in three scores on the Living with Pulmonary Fibrosis questionnaire: dyspnea score, cough score and fatigue score. Between baseline and week 52, patients receiving the nerandomilast doses had comparable changes in these three scores to patients receiving placebo.
Researchers also noted that similar proportions of patients receiving nerandomilast and patients receiving placebo experienced a first acute exacerbation, a respiratory cause hospitalization or death (18 mg, 21.7%; 9 mg, 20.2% vs. 20.4%).
When looking at death alone, Wijsenbeek highlighted that “there are numerically fewer deaths in the 18 mg group twice a day compared to placebo.”
Notably, a greater proportion of patients receiving placebo vs. nerandomilast who did not use supplemental oxygen at enrollment received supplemental oxygen during the trial (19.5% vs. 18 mg, 16%; 9 mg, 12.1%), according to the study.
Safety
In the nerandomilast groups, 95% of patients receiving the 18 mg dose and 93% of patients receiving the 9 mg dose reported an adverse event, and this was comparable to the 94% of patients in the placebo group.
Researchers highlighted that this pattern continued when evaluating the proportions of patients who experienced a serious adverse event (18 mg, 30%; 9 mg, 31% vs. 33%).
A greater proportion of patients receiving either dose of nerandomilast vs. placebo reported diarrhea (18 mg, 41.3%; 9 mg, 31.1% vs. 16%), according to the study. This finding held true across each background antifibrotic subgroup, with the highest proportions of patients reporting diarrhea in the nintedanib group (18 mg, 62%; 9 mg, 49% vs. placebo, 27%).
Slightly more patients receiving 18 mg nerandomilast had to permanently discontinue treatment due to an adverse event vs. patients receiving the 9 mg dose or placebo (14% vs. 11.7% or 10.7%). Additionally, researchers found that diarrhea was the adverse event commonly behind these discontinuations (6.1% vs. 1.8% or 0.5%).
The adverse events of interest in the trial included depression, suicidality, insomnia, nervousness combined with anxiety, vasculitis, potential drug-induced liver injury and severe/serious infections, and Wijsenbeek noted similar rates of each event across the 18 mg nerandomilast group, the 9 mg nerandomilast group and the placebo group.
“Safety data suggested that the adverse events that were associated with nerandomilast are manageable,” Wijsenbeek and colleagues wrote in the study.
When broken down into the three background antifibrotic therapy subgroups, researchers observed that a higher proportion of patients using nintedanib vs. pirfenidone or no therapy had to discontinue treatment due to an adverse event.
“These findings serve as the basis of regulatory filings worldwide,” Leticia Orsatti, MD, vice president of clinical development and medical affairs at Boehringer Ingelheim, told Healio. “The U.S. FDA recently granted priority review to the [new drug application] for nerandomilast in IPF, with an anticipated action date in the fourth quarter of 2025.”
Reference:
- Wijsenbeek MS. A82 Breaking news: 2025 clinical trial results in pulmonary medicine. Presented at: American Thoracic Society International Conference; May 16-21, 2025; San Francisco.
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Was hoping for better results than this. Not really stopping progression of the disease as first advertised. Seems like only an incremental improvement over Ofev. I’ve been on Ofev for two years now and, fortunately, I’ve had little to no side effects. My condition was pretty stable for over a year, but recently it’s gotten a bit worse, so I’ve been hoping this would be approved soon. FDA approval in the 4th quarter, then getting on the Medicare formulary probably means almost another year before it’s available. Oh well, just have to keep plugging along.
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hi Mike:
It is not as expected, but, it apparently it is better tolerated and slow the fvc a bit better.
i was hoping it would do better based on the phase 2 reports, as i m looking for anythig that works for may wife.
so far see is not taking anithing because she for some reason has been stable for almost 2 years. we base this succes in her daily activities , some weight lifting and good diet, the only supplement she take as a tea called mullein tea, she drinks 1 litter during the day, and has helped so far to mantain spo2 north of 96
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