[Alex Marion]

Hi.

Bi1015550 phase 3 trial ended en August. It looks that they have to gather all the data and satisfy the fda for final approval.

Apparently, for what I read , it has less side effects of the current drugs, and works at 60% stopping the progression in fact as per data of phase 2.

Bristol Mayer also in phase 3 with somewhat successful phase 2 for the drugs.

Many more in phase 2 , but looks like soon some new drug treatments will be approved for ipf as it is needed ASAP.

The present treatments only work in 40% of the people and some with bad side effects, I think that bi1015550 will be available in 2025/26 .

All the best

[Donna Ingalls]

Just realized that the drug number you mentioned in your discussion (BI 101 5550) is the one I’m on in a clinical trial! Don’t think the trial is actually over as I won’t be finished with mine until October. Not sure if I’m on the drug or a placebo, but I’ve lost 20 pounds and have had constant diarrhea (manageable) since I started the trial. Don’t feel too much worse since I started last fall which is promising. So maybe it is working! Not using oxygen but the stairs are tough and I’m breathless walking up hills. I was diagnosed in December 2022. I’ll keep you posted!

[Alex Marion]

Hi donna:

Finally someone who is in the trial.

Is my understanding that ,yes, you may be taking the drug not the placebo, because of the diarrhea, that for what I red, is the commun side effect.

As per phase 2 that only run for 12 weeks, they finding was fvc not going down, in fact, improve marginally, and spo2 normalized, as per one patien description of his experience.

Yes, the trial continues till December but, in August ended for ipf , as per the manufacturer says in their website.

You the only one I have encountered who can share the experience, and if something else you can add, we will be great.

Thank you.

[skaduzy]

I am also in this trial and feel much the same as Donna except I did not lose 20#….more like 10. Started taking in July 2023 and felt pretty good but after I started my pill packet in December the diarrhea started and I don’t know what changed. I am also on generic Esbriet since June of 2022 and don’t know if that had something to do with the change.

The phase B of phase 3 is starting soon and I am continuing into that portion of the trial.

[Alex Marion]

Hi,

Thank you for sharing the temporary outcome from the trial.

I also read that improve spo2, as per the testimony of another patient in the trial.

The diarrhea is consistent with the sideffects but It would be good to know if the patient are taking only bi 1015550 .

I think the phase 2 shows minimal sideffects on those patient compare with the ones that combine ofev and bi 1015550.

Did you feel improvement? Have you had an spirometry showing decline or stability?

Best Regards

Alex

[jackm]

I have been in this study for some time now

I don’t know if I am on placebo or the drug – but thank God my numbers are stable, and I don’t have any noticeable side effects

My docs think I probably am on the drug, and they think it’s going “red Label ” in October. That means the actual drug will now be given to all study participants through the end of the trial and until FDA approval- when it will then be available to all

My Clinical trial group is very excited by the results and promise of this new drug when used together with Esbriet as the results seem very promising to significantly retard or even stop the progression

I am confident this new drug will be a blessing to all afflicted

stay positive

[Denny]

Is it too late to get into the trial? What is the name of the drug?

Denny Eliassen

[bessey]

I too am in a Clinical drug trial for a new IPF drug. It’s in Phase2b/3 at present and started in August 2023. Pliant Labs Inc is running it worldwide and is currently recruiting new participants. It is called the Beacon IPF trial and data so far is very positive. It is a double blind study. You have a 2 out of 3 chance of being on either the low dose or higher dose of Bexotegrast. I believe I am on the drug with very mild side effects. Mild diarrhea and intermittent metallic taste. My FVC and DLCO have not worsened whatsoever and my persistent cough is gone. I have been in the study for 6 months. It is a 52 week study. I wanted to share in case someone out there is looking for a new trial. I am not on any of the current antifibrotics that have been around for a few years.

[Denny]

How can I get in the trial? Where is the study done?

Denny Eliassen

[JKU]

I too am in the Pliant trial. I also take Ofev. I was diagnosed in Oct 2023. I just had my 6 mo trial check up and there was NO change in pulmonary function tests or CT scan. This trial is still ongoing. My side effects are the same as with Ofev. At this point I’m very encouraged!