Boehringer Ingelheim 1015550 fibroneer study

[Mack]

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

[Clsyldy.]

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.

[Sheila Curran]

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?

[Paul75]

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.

[JKU]

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

[Steve Dragoo]

What were your results in the trial and post? Thanks…

[Alex Marion]

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 👍

[Steve Dragoo]

Thanks a lot Alex. Good insights. I’ve been on this platform (PF News) since mid-2018…

[Mack]

Hy Steve, please keep us posted about any news you come across concerning this new drug.

Thanks,

Mack

[Steve Dragoo]

Wll do. I was offered a slot in phase 2 of the Boheinger but out of the country at the time so missed it…

[jackm]

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 –

[PattyO]

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.

[laura4225]

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.