Debio-025

[Bali05]

About Debio 025
Debio 025 is an oligopeptide that has some chemical features in common with cyclosporine A, but is devoid of its immunosuppressive pharmacological effects. It has a very potent inhibitory effect on HCV replication both in vitro and in vivo. Debio 025 has excellent antiviral activity against a broad range of genotypes (1, 2, 3 and 4); a high barrier to the development of resistance; and the possibility for once daily dosing. It is expected to have a superior safety and efficacy profile to standard of care, and to be efficacious in patients not responding to the standard treatment.

Its potent inhibitory activity on the HCV replication was shown in the following clinical studies. Results of a phase Ib study demonstrate that Debio 025 monotherapy for 15 days induced a strong anti-HCV effect (3.6 log10 reduction) in HIV-1/HCV co-infected patients (Hepatology, 47:817-26). Results of a phase IIa study with Debio 025 indicate that Debio 025 shows an important additive anti-HCV effect (4.6 log10 reduction) when co-administered with peg-IFNα2a for four weeks to treatment-naïve HCV patients (Hepatology, 2009 May;49(5):1460-8).

Sounds good does`nt it ?

Anybody with more info on this one, perhaps doing trial phase2b ?

[nygirl7]

Well good for it I hope it does brilliantly and is approved in a few years I really do. The more the merrier,  even those late to the party!!!!

[BelB64]

I wouldn't write off debio-025 so fast. Every study written about shows debio is VERY potent against all genotypes. Of course not everyone will be successful as Susan400 wasn't, but as Bali05 states this information is VERY current. The early trials look like the debio was only used for the first four weeks then SOC. I just listened to the presentation Pharmassett did on April 1 in NYC at the canaccord adams conference, and they are EXTREMELY excited about their inhibitor r7128 and of the very real possibility that interferon free treatment with a combination of inhibitors isn't that far off. They're doing the INFORM-1 and soon to be INFORM-3 trials without interferon and they stated in their presentation that the early viral kinetics are very similar to those of interferon and riba. The information they are waiting for will be the svr rates and they will come at the end of the year. The inititial log drops were impressive.

This is where a debio-025 may play a big role. The pharmassettt spokesman said his product  and Roche's could be combined with other inhibitors to create a situation that eliminates rejection and breakthrough.  It was a very interesting presentation and I think it's still on Pharmassett's website.

[nygirl7]

No problem you know there are a lot of us that remember the days before Tele and Boce - now look how many lives they are changing.  We are all, all for something to make the cure rates better and the times shorter (or even just the cure rates better honestly) for all genos!

[Bali05]

thanks for following up

[Bali05]

at this point all i am reading and that is recent news is that it has good activity
against geno 4 and got liscence for futher trials.
Looking for anything that shows antiviral activity for geno4 and in that
connection  I read about today. Geno 1 soon has Tele+Boce , geno 2&3
are considered easier and above all nothing is true all the time.

cheerio

[nygirl7]

Oh there you go she answered you, yay,she's a good egg.

[nygirl7]

After checking with Susan just to make sure folks know, she did do this trial it's Debio and Interferon both.  Unfortunately this was several years ago and it didn't work (I am pretty sure it was televapravir that they did not give her the ribavirin in but only interferon and that way it does not work either and ruins the chance that they will let you in another type of the same trial (ie; bocepravir).  With a trial one never knows what you are going to get.)

But yes, this has been around for quite some time and has had none of the huge press of tele and boce.  Not sure I'd want to trial it.

[susan400]

Bali,

I was in a Debio-025 trial about 20 months ago.  At that time, I was using Debio B.I.D. as well as Peg and Riba.  It was given w/SOC.  That was the trial I was in, in the U.S.  I did not clear the virus, but that is not to say that it would not be possible in another person.

Susan400

[Bali05]

thank you

[jdwithhcv]

Well, good for you.  I know it was a difficult choice.  For me,  once I commited to it and got going it felt like I had cleared one of the hurdles.

Remember, we are here to help you through it.  Even in the middle of the night, I could always find someone on the forum when I needed advice, or to vent, or just to get me through a night of insomnia.

Wishing you the best.

jd

[Bali05]

"He is now looking at 'backup plans' i believe JD for when you know the SOC doesn't work"

Back plans have an anti depressant effect on me.

[Bali05]

that` what I thought

[Bali05]

you read correctly

[jusjames]

looking like good news if this is true

[nygirl7]

He is now looking at 'backup plans' i believe JD for when you know the SOC doesn't work.

[nygirl7]

I know Susan was looking into this a few years ago I cant' remember if she did it (as you know she's tried just about everything out there in her ten treatments) but I did send her an email to see if she could post to you.

You shouldn't worry so much about what if it DOESNT work on geno4 - I had two strains of geno1 (1A and 1B) and my odds weren't so hot with stage 3 but still I just believed I WOULD beat it and I did.

No telepravir sides to worry about just general old SOC sides - and geno4 isn't going to be harder than that most likely.  If I could handle it and be a single mom and work fulltime - you can handle it for sure.

[jdwithhcv]

Are you starting SOC?  I saw somewhere else that you are predosing riba and have the inf in your fridge.  Are you going to start SOC in the next week or so?

[Bali05]

How old are the news ?

Basel, February 9, 2010 - Novartis has gained exclusive rights to develop and market Debio 025 (alisporivir), a potential first-in-class antiviral agent currently in Phase IIb development for the treatment of hepatitis C. Debio 025 is the first in a new class of drugs called cyclophilin inhibitors which could become part of the future standard of care for the disease.

[Bali05]

really , just read about this in a german magazine that is published
by the  "Deutsche Leberhilfe e.V." German Liverhelp Assoc.
It is a quaterly pub and was talking about Debio-025 being active
against geno 4.

Anyway keeping my radar open for anything that shows efficacy for
geno4. Tele and Boce unfortunately don`t.
Need to have something to focus on in case Alinia+SOC won`t
do it for me.

So, if you see anything showing to be active against geno 4
I would be very thankful if you could share it.

I am afraid if  this continues like this geno 4 soon will be the hard to treat one.

[nygirl7]

Old news - ask Susan400 about this one.  I'll try to flag her and have her tell you about it, I don't remember too much but this was out years ago and I haven't heard anything since so I don't think they had success.