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Potential new drug in phase 2, claims to show better effect than Sotatercept
Hello!
I’ve been following this forum from the sidelines for a while and have pretty much read everything written here.
I am particularly interested in the clinical research being conducted on new treatments and having followed the forum for a while I know there is quite a lot going on on the research front. It will be really interesting to follow the FDA’s decision regarding Sotatercept in early 2024.
I myself live in northern Europe and here too we have a number of companies that conduct research in the area. Most carry out their clinical studies in the USA so we Europeans have very few opportunities to be included in these.
Sotatercept is probably the candidate we are all waiting for with the most excitement and I have followed the drug’s development for a long period. However, I have come across another drug called CS1 which is currently in a phase 2 clinical trial. Here they have reported partial results of the study and also reported the results of the effect on one of the patients (the rest are still blinded). To my great surprise, I think I see a better effect from CS1 than what Sotatercept could report. In addition, the phase 2 study of CS1 is carried out in collaboration with Abbott and above that, you have a scientific board consisting of prominent people in the field such as Dr. Raymond Benza and Dr. Deepak Bhatt.
I wonder if anyone here, with all your knowledge and dedication in the field, has heard of CS1 before? Is this a candidate that could possibly be as promising (if not more so) as Sotatercept?
Here is information to read about the effect on one of the patients:
https://cerenoscientific.com/press-single/?releaseIdentifier=99C3CB5850C19A5B
For those who are interested, I am happy to share a comparison in effect with Stotatercept as well.
Please share your opinions with me. I am very curious about CS1 and would love to hear if anyone has any opinions or thoughts on this candidate.
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46 Replies
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Hi Jojan, very interesting and promising study for PAH. Thank you for forwarding on this new research – looks like it could be another break through for so Nanyang with PAH.
The FDA has a “must approve or not” of March 26th for Sotatercept. I am definitely in line for that injection every 21 days. My Pulmonologist also sees this as very promising for patients with either subQ or IV sites. Thsnk you again Jojan 😊
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Thanks Carol! Yes, Sotatercept is something we are probably looking forward to. It is good now that research is moving forward and that more treatments seem to be coming for us. I will be very surprised if the FDA does not accept Sotatercept. I read this article in CBS recently. Can anyone guess what treatment or clinical study this lady received? The course of her illness seems to have improved extremely much and the journey she has made is impressive and hopeful to say the least. It would be very interesting to know what kind of treatments she received.
Here is the article:
https://www.cbsnews.com/amp/minnesota/news/from-being-told-she-had-3-days-to-live-to-running-her-1st-5k-race-amanda-fischer-believes-in-miracles/
cbsnews.com
From being in hospice to running her 1st 5K race, Amanda Fischer believes in the power of miracles
For Fischer and her son, Paul Benally, the first health scare came 11 years ago when he was bit by a mosquito and contracted encephalitis, which caused his brain to swell. That was only the beginning.
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Wow, what an incredible story, @Jojan! That’s impressive results, and I appreciate you sharing this story. I had not seen it, and I know others will also enjoy and become inspired after reading this story.
I also am exciting to learn more about the CS1 you shared. The upcoming years will be an incredible time to lewarn about these new treatments.
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Now I may be rude but I have actually tried to contact Amanda via social media with no success.
Do you think it’s going a step too far? I am so curious as to what kind of treatment she received and it would have eased my conscience to know that it is a treatment that is possibly about to become available on the market.
My opinion is that the more treatments there are in PAH, the better it is for all patients. Everyone reacts differently to different types of treatment, but the more opportunities there are, the better for everyone.
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Hi @Jojan, I don’t think trying to contact her on social media is rude at all. I don’t know of her either. IDK if she may be a member of any FB PH groups, but that may be an option to look for her. Or did you locate her and message her with no response?
Yes, you make a solid point about how we are all different. However, the more treatment options available will eventually benefit many of us in the PH community. Thanks again for sharing.
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Hi @jen-cueva , Thanks! I have contacted her via LinkedIn but haven’t heard back yet. I have not been able to find her on any other social media. I have actually also contacted the journalist who wrote the article about her but I have understood that they are absolutely not allowed to give out any contact details to her.
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That was an inspiring story!! To go from a death bed to running a 5K is truly amazing. It would be nice to know what drug/drugs she was on. Thanks for posting that.
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Thanks! Surely it was? I am frankly very interested in knowing what treatment or treatments she received.
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I agree, @Jojan. It would be nice to know, although we all respond differently to these PH treatments.
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I follow this company called Cereno Scientific in Europe, which has so far shown exciting results in PAH disease. Now I see that they are moving forward with Compassionate Use of their drug candidate, even though it is still in clinical phase 2 study.
Does this mean that anyone will be able to apply to take this medicine?
So far I haven’t been able to get in touch with Amanda, who after being really sick with PAH recovered to the point where she could run a 5K race. Anyone have any input, thoughts or ideas about the whole thing?
Link from the company’s website regarding Compassionate Use:
https://cerenoscientific.com/press-single/?releaseIdentifier=8E874A7049CD09FD
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Hi @Jojan, this article refers to the study’s patients. It looks like it would allow them to continue receiving this treatment even after the trial is done.
From what I’ve understood, “compasionate use” is usually for patients with life-threatening illnesses without any treatment options available. It would also be up to the physician’s medical team to decide whether other treatment options offer relief.
Others may have other thoughts on this compassionate use program. Thanks for sharing, and I hope others will contribute to this discussion.
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Hello Jojan, did you find out which drug Amanda received>
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Hi Robyn Doyle, Unfortunately not. I have not been able to get in touch with her. Do you have any idea what drug it can be?
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Sorry Jojan for my tardiness in not replying earlier. No I don’t know what drug and I am very skeptical regarding this woman’s story.
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Very good news for the entire PAH sector:
The interesting thing is that it is the same Dr. Raymond Benza who leads Cereno Scientific’s study in PAH for candidate CS1 which has shown convincing effect in the disease.
mountsinai.org
Raymond Benza, MD, Heart Failure Expert, Named Chief of Pulmonary Hypertension for the Mount Sinai Health System | Mount Sinai - New York
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I found this research article about CS1.
Seems to be very promesing:
https://onlinelibrary.wiley.com/doi/epdf/10.1002/pul2.12323
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I appreciate you keeping the PAH community up to date.
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Cereno Scientific is granted Expanded Access by the FDA to drug candidate CS1 for rare disease pulmonary arterial hypertension:<div><b style=”font-family: inherit; font-size: inherit;”>
</div><div>https://www.placera.se/placera/pressmeddelanden/2024/01/31/cereno-scientific-cereno-scientific-is-granted-expanded-access-by-the-fda-to-drug-candidate-cs1-for-rare-disease-pulmonary-arterial-hypertension.html<b style=”font-family: inherit; font-size: inherit;”> </div>-
Hi @Jojan, you are keeping updated about CS1 and the FDA approval for compassionate use. Have you discussed this with your PH care team? I hope to remember to ask mine about this update when I see him next.
How are you doing?
It will be a hopeful year for us in the PH community! So excited about possible new clinical trials and FDA approvals offering us more treatment options. Thanks for sharing!
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Hi Jen, Yes, it seems to be an exciting drug they are developing. Yes, I have discussed this with my PH team. They too are excited about this drug and think it shows very promising results. Dr. Raymond Benza, who you probably know, is on the scientific council of this company and he also praises this medicine. Unfortunately for me, I don’t live in the US which means I can’t join their clinical studies. But for those of you who live in the US, I would suggest you to contact the company to check if there are places left in their study. The main thing is that research is progressing in PAH and the important thing is that there are new disease-modifying drugs on the market. What are your thoughts about this drug?
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Thanks @Jojan! Here’s an article by our News team published this morning on our PH News website. It’s an interesting drug, mainly because it’s a reformulation of valproic acid, an anti-seizure drug. I’ll see my PH team next week and ask his thoughts on this treatment.
But, because I’ve experienced “seizure-like” episodes multiple times, this may be something I could benefit from.
pulmonaryhypertensionnews.com
Cereno's PAH investigational candidate CS1 granted compassionate use
The FDA has approved the use of Cereno Scientific’s CS1 in an extension of the ongoing Phase 2 trial testing the therapy in people with PAH.
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Hi Jen, Thanks for sharing the article. It was really good. If appropriate, please share what your PH doctors said about this treatment. Hope it can help you and many more.
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Hi @Jojan, it’s my pleasure. I’ll certainly update what my PH team has to say about this treatment. I see them later this week.
How are things with you this week?
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Thanks Jen! This week is an “up week” for me so far. More energy than last week, which I now try to take advantage of by going out with the dog as often as I can. Unfortunately, the walks with the dog are not as long as I would like, but I have to make the best of the situation. You never know when it will turn… How is your week going?
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Hi @Jojan, I’m so happy you’re having an “up” week. Like you, I tend to take advantage of those days.
I can so relate to shorter dog walks. That’s me these last few weeks with mine.
My week is an “off” week. I’ve been experiencing a variety of side effects/symptoms. I may have found the culprit: a new medicine for my gout. But I also see my PH team on Thursday afternoon to see how I’m doing post-bronchitis and if my PH is progressing.
Thanks for sharing and asking about my week. We work together as we have up and off days.🤗
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Hello there Jen,
Hope your week turns up then. The up weeks are great and the down weeks are less good. If you weigh great against less good in a scale, the outcome is still positive… it’s all about having a positive mental attitude with this disease 🙂
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Hi @Jojan, you share an important tip. Like you, I reference my days as good and not-so-good days. A positive mindset(most days) has gotten me to my 19th year with PH next week. 💜
Thanks for the support, my PHriend! Enjoy your weekend.
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Wishing you a fantastic weekend too! Did your PH team have any opinions you feel you want to share about the study in question? I have geeked out on clinical studies in PH/PAH and apart from Sotatercept, CS1 is the most exciting thing. I sincerely hope now that Sotatercept will be approved by the FDA at the end of March. After that, I hope that CS1’s research progresses so that you can possibly get both treatments in combination.
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Hi @Jojan, thanks for your thoughtfulness. I saw my PH team on Thursday. Unfortunately, because I was experiencing some complications, we didn’t get to discuss CS1. But we have discussed sotaracept a few times. He did say if my current treatments stopped working, he thought it would benefit me. But he was also excited about how many patients sotaracept could help.
I’ll try to remember to ask about CS1 when I talk to them again.
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Hi Jen, Oh my, hope your complications are better now my PHriend! Yes, Sotatercept will certainly help a lot of patients and I am so glad that the research is moving forward. Regarding CS1, I have a relative in the states who, on my behalf, has been in contact with one of the sites holding the study. According to them, the study is only 12 weeks long and they are just in the final stages of patient recruitment. This contact was made before the New Year. Unfortunately I wasn’t able to attend as I don’t live in the states but from what I read about CS1 I would definitely recommend you look into it further if you are interested in being part of their study.
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The Expanded Access / Compassionate Use program the company applied for was approved by the FDA.
Today, the company has announced that it dosed the first patient in this program. It also seems that it is patients and doctors who have asked the company to apply for this program. Now the program seems to be running and surely has to mean that this drug has a good effect against the disease PAH, or what do you think?
My thoughts are that why would one request and want to be part of an expanded access / compassionate use program with this company when Sotatercept/Winrevair is approved? Does anyone have any input regarding this and know how to go about getting included in this program? Here is the company’s press release: https://cerenoscientific.com/press-single/?releaseIdentifier=4F9329BB5D5C0FF6-
Hi @Jojan, Thanks for always keeping us updated about this. I also want to share that our PH News team shared this article, and I will link that below, too.
In my opinion, I’m not 100% certain that I would try this treatment if it was available to me. My reason is the treatment is basically an older anti-seizure medication, which sounds like it offers some other benefits, it would take many more studies for me to ask mny PH team about it.
If you’re not in the US, you can’t get the compassionate care benefit, I would guess. I think you should contact the company diretcly and ask those questions and in regards to your location.
How are you doing?
Our PH News team article titled <em style=””>”CS1 Receives Orphan Medicinal Product Status for PAH in Europe.“<strong style=””> Let us know your thoughts on this news!
https://pulmonaryhypertensionnews.com/news/cs1-receives-orphan-medicinal-product-status-pah-europe/
pulmonaryhypertensionnews.com
CS1 receives orphan medicinal product status for PAH in Europe
The European Commission has granted orphan medicinal product designation to Cereno Scientific’s CS1 for pulmonary arterial hypertension.
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Hi Jen,
Time flies and it’s been a while since I checked in here so I completely missed your post, sorry about that.
About Cereno Scientific, which I am becoming more and more interested in, they have another candidate called CS014. Today, preclinical results were released, where, among other things, you can see signs of a disease-modifying effect in PAH. Wouldn’t this be huge for anyone suffering from PAH?
Here is a link to the press release:
https://cerenoscientific.com/press-single/?releaseIdentifier=B0B06D415CE47689
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@Jojan this is so interesting and hopeful! Thank you so much for sharing. Would love to hear the thoughts from members about this.
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Hi @Jojan , that would be incredible! 🙏
At the PHA Conference last month, they discussed that several new treatments in the pipeline, like sotatercept, would target the causes of PAH rather than slow the progression of the disease, like many of our available treatments.
Thanks for sharing, and it’s great to “see” you pop in again. How are you doing, My PHriend?
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I have been waiting for my doctor to give me the go-ahead for Winresvir. I was reading about the patient who went from hospice to running a 5k. THAT is a miracle! I would love to be able to WALK the 5k. Hopefully, development of drugs will continue and someday we can see this terrible disease in the rearview mirror!
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@Cris Dingman fingers are crossed and I am praying that you get the go-ahead! Please keep us updated! I hope we get to witness your gradual improvement and cheer you on as you walk a 5K!
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Hi, @Cris Dingman that would be incredible! I am keeping my fingers crossed, and I can send you positive thoughts that you’ll start the Winrevair!
And yes, hope was the word I felt used most often at the PHA Conference last month. Hope because we have many new possible treatments in the pipeline and many that can reverse the disease, so promoising. A 5k, heck, a block or two would be a huge win in my book!
Have a wonderful weekend, my PHriend! Keep us posted and so wonderful to see you pop in and a brief update in the forums. 💜
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Hi guys,
I’m fine thank you very much @jen-cueva , how are you?
Yes, I also paid attention to the PHA conference and it sounds really promising that more candidates are on the way. It is, of course, even more promising that they now focus on disease modification rather than slow the progression. Hopefully these new therapies could promote and support prolonged life and lifequality for everyone with PAH.
Thank goodness for all the smart scientists out there!
As far as this company, Cereno Scientific, is concerned, they aim to report results within the end of this month for their leading candidate CS1, which operates specifically within PAH. This is a result that I have really longed for as I believe that this medicine could be a breakthrough for anyone suffering from PAH.
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@Jojan I am looking forward to following this progress! Medical science is amazing and God I hope in this case especially…life saving!
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Hi, @Jojan it’s good to hear you’re doing well! I’m doing well today, thanks. Sleep always helps!
Yeah, the PHA Conference was so unique and inspired so much hope. I thanked so many of our researchers and scientists for working behind the scenes on our behalf. It’s amazing how much progress is being made in understanding and treating pulmonary hypertension.
Take care, and thanks for keeping us posted. I subscribed to Cisnernos to stay updated. But I also want to share this article our PH News team published today. Check it out below.
Have a wonderful weekend!
pulmonaryhypertensionnews.com
PAH therapy reverses blood vessel remodeling in preclinical model
Therapy candidate CS014 reversed remodeling of the pulmonary arteries in a preclinical model of pulmonary arterial hypertension (PAH).
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There is a lot going on now in this exciting company.
Very recently there was a press release stating that Cereno Scientific reports a positive topline in its phase 2 study for the main candidate CS1 within PAH. You see convincing signs of clinical effect while also seeing signs of disease modification.
So far I have probably never seen such convincing results in a PAH study as in this one.
I think this is very exciting!
Link to the press release:
https://cerenoscientific.com/press-single/?releaseIdentifier=2D7F159764FDB891
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Hi @Jojan , yes, that’s the press release I also shared that our PH News team published last week. It certainly offers hope for many new treatments for us all with PH.
Disease reversal, as the article shares, is inspiring and so hopeful. We all push towards a cure, and until then, we are extremely grateful for all the passion and dedication these scientists and their teams show.
Thanks for always sharing and bringing this to us all to inspire HOPE!💜
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Hi @jen-cueva
This is actually additional news.
What you refer to applies to the company’s drug candidate called CS014.
This news is about their lead candidate called CS1, which has just reported topline data in its phase 2 study.
Interesting here, apart from the disease-modifying properties, is that CS1 manages to show better results on certain parameters than Sotatercept managed to show in its Phase 3 study. The CS1 study is for 12 weeks compared to Sotatercept’s study which was for 24 weeks. This means that CS1 shows better results on certain parameters in half the time that Sotatercept showed.
This is very interesting to me!
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Whoops, that’s my mistake; this is even more hopeful than I was originally, @Jojan .
With this and the Prosera inhalation in their Phase III trial, amongst other things, many new treatment options should be upcoming, which is quite promising news.
Yes, with the benefits of sotatercept, CS1 being shown to offer even more improvements, is definitely a plus! I’ll keep all of these in mind and in my prayers, hoping that we will all have some treatment that helps us reduce and possibly regenerate the damage from PH. 💜🙏
Thanks again Jojan!
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Hi again, @jojan. I find it funny that you share the updates a day or so before our PH News team writes an article.
Below, I’ll share their latest link abouyt the CS1 as we had been discussing. Let’s see what others think about this hopeful news.
Is there a particular reason that you only focus on Cereno’s clinical trial updates?
https://pulmonaryhypertensionnews.com/news/cerenos-cs1-found-safe-signs-efficacy-pah-top-line-data/
pulmonaryhypertensionnews.com
Cereno's CS1 is found safe, shows signs of efficacy in PAH:...
The investigational therapy CS1 led to beneficial changes in for people with pulmonary arterial hypertension in a Phase 2a clinical trial.
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