[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!

[Alex Marion]

\Hi to all:

Digging into more information, i found this article regarding bi1015550 , and it may be a complementary drug to the current treatments.

Exploring Nerandomilast’s Value in the Complex IPF Treatment Landscape

Author(s):

Hayden E. Klein

Martin Kolb, MD, PhD, discusses the challenges of treating idiopathic pulmonary fibrosis (IPF) and highlights the potential benefits of a new PDE4B inhibitor, nerandomilast.

Current Time 4:07

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Duration 4:07

Loaded: 100.00%

Idiopathic pulmonary fibrosis (IPF) remains a challenging and progressive disease with significant unmet needs and high mortality rates, despite the availability of 2 approved antifibrotic treatments. In this interview, Martin Kolb, MD, PhD, professor of medicine at McMaster University, delves into the complexities of IPF treatment and explore how nerandomilast, a new PDE4B inhibitor, could offer a valuable alternative by targeting different pathways involved in disease progression.

According to Kolb, “by adding blockage of a different pathway to the ones that we currently block, we might achieve, hopefully, a more profound impact on disease progression.”

Kolb also serves as a pulmonary physician and director of research at the Firestone Institute for Respiratory Health at St. Joseph’s Healthcare, as well as Jack Gauldie Boehringer Ingelheim Chair in Interstitial Lung Disease.

Transcript

What are some of the challenges and unmet needs in treating IPF?

IPF is by definition a progressive disease, and the untreated mortality rate is about 40% to 50%. Now, we have 2 antifibrotic drugs available which have clearly had an impact on many people, but not all. On average, there’s still quite a few people who either don’t tolerate the drugs or they just partially respond or they don’t respond at all, that’s why the overall survival rate is still way worse than what we like to see. So, there is a big need to get drugs that help on top of existing drugs, and drugs that are alternatives to the ones that we have because they are not tolerated or they don’t work. So, there’s a lot of need for this field.

How does nerandomilast differ from current antifibrotic treatments, and what are some advantages of its mechanism of action?

It’s a PDE4B inhibitor, and I’ll emphasize a few differences. One is that we have worked with PDE4 inhibitors for a while for other diseases, and that means there is a pretty solid understanding of the safety of this drug class. PDE4B is something that is less expressed in the intestinal system, which means things like diarrhea are probably less of a problem for this PDE4B instead of the PDE4 inhibitors.

It affects 2 elements in wound healing. The one is fibrosis, so it interferes with fibroblast proliferation and scar formation driven by fibroblasts for one, and the other part is that it also has a built-in anti-inflammatory effect. And we know that, while IPF is not the prototypical inflammatory disease, there is still some kind of immune activation going on, and it would certainly be a little bit different to other antifibrotic drugs that primarily focus on the fibrosis only. It’s still mainly an antifibrotic drug from the concept that we pursue here, but it has a few added elements that could become beneficial, particularly for diseases that have a concomitant inflammatory component such as progressive pulmonary fibrosis.

Why is it challenging to treat IPF with a single drug, and how might nerandomilast contribute to the treatment of this disease?

It’s a complex disease, and 1 drug will never hit it all. There are different components and they are active at different times in an individual patient’s journey; they are different in the different spaces of the lungs. You may have areas that have one biology more active, and other areas a different one, so it’s unlikely that one single drug will ever have a profound impact on all patients because it’s such a kind of multifaceted biology.

I wouldn’t necessarily say that nerandomilast and that pathway that’s targeted is better than the others—we’ll have to find out with the clinical trials—but it certainly is different from the others, and that’s why it is valuable, similar to other approaches currently, because it’s not a biology that is currently catered to by pirfenidone or nintedanib. So, it’s different and makes it valuable, and you would hope that by adding blockage of a different pathway to the ones that we currently block, we might achieve, hopefully, a more profound impact on disease progression.

ajmc.com

Hayden E. Klein

Hayden is an assistant editor for The American Journal of Managed Care® (AJMC®) and joined AJMC® in 2021, where she produces written and video content covering multiple disease states. She has a BA in journalism & media studies from Rutgers University. … Continue reading

[Steve Dragoo]

It is good news that multiple trials in 2 or 3 are favorably advancing. I missed a couple of opportunities but Ofev seems to help a little for now + a bunch of supplements…

Stay well…

Steve

[jim cyrus]

I have been in the Fibroneer study since June-July 2023. My FVC has stayed 69-70 and I am not on oxygen.. I also take Pirfenidone and have for several years I was diagnosed in July 2018. No side effects

since I have been taking the study drug or placebo.. I am looking forward to switching over to the drug soon, but no word yet from Cleveland Clinic as to the date.

wish everyone all the best. Jim

[skaduzy]

Jim, I, too, am anxiously waiting for news from Cleveland Clinic for the next phase when I will be getting the real drug, if not already. Best to you in your journey with IPF.

[Sally]

I was on Nerondomilast, Fibroneer Trial, from July 2023 until last month when it ended. I have been on the “real” drug, high dose, for two weeks. I have been experiencing diarrhea – sometimes bad, sometimes ok. I have taken Imodium which helps. The Trial doc says to just take a preventative 1/2 or whole Immodium in the morning. I also have IBS and one of the reasons I have never been on the other two drugs. I was diagnosed in 2014 and was doing great (no oxygen except for flying or above 2,500 feet) until 3 years ago when I had a major exacerbation and was in the hospital for 2 weeks. Since then, I have been on 24/7 oxygen beginning with 8 lpm, then down to 4 and now at 6lpm. I am pretty positive I was on the placebo or the low dose considering the reactions I am having now. This trial extension is for 96 weeks and then hopefully it will be FDA approved.

[Alex Marion]

Is the trail of bi 1015550 continues recruiting ?

Is someone tryinh the bristol Mayer phase 3 ?

[J L LaBrack]

I’m 81 and have had IPF diagnosis since May 2018. Opted out of Ofev and Esbriet. Got a diagnosis of Rheumatoid Arthritis (also, like IPF, and autoimmune disease) in June this year. Rheumatologist will be starting me on adatacet (Orencia) which is administered via an effusion process once per month very soon. Said it will benefit and alleviate both diseases with measurable results. Has anyone else heard of this? Could be a real boon to us!!