Kadmon Therapy Slows Progsn of Pulm Fibr, Phase 2 Trial

[gerald]

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Kadmon Therapy Slows Progression of Pulmonary Fibrosis, Phase 2 Trial Shows


Kadman's KD025 slowed the progression of idiopathic pulmonary fibrosis and patients’ decline in lung function, a Phase 2 clinical trial shows.

The IPF patients in the open-label trial (NCT02688647) had previously been treated with Genentech’s Esbriet (pirfenidone) or Boehringer Ingelheim’s Ofev (nintedanib) — or had been offered treatment with them. Researchers randomly assigned the trial participants to 400 mg of KD025 or supportive care.

KD025 inhibits Rho-associated coiled-coil kinase, or ROCK2, a molecular pathway involved in IPF and other chronic diseases. Preclinical-trial studies by Kadmon and others have shown that the ROCK pathway is a crucial player in the development of pulmonary fibrosis.

The primary objectives of the 24-week trial were to see whether KD025 was safe and patients could tolerate it well. Researchers also looked at its effectiveness. The yardstick was changes in a lung function measure known as forced vital capacity. FVC is the amount of air a person can exhale after a deep breath.

KD025 reduced patients’ decline in FVC at week 24 by 73 percent, compared with patients receiving supportive care.

It also reduced the percentage of IPF patients whose disease had progressed at week 24, compared with the supportive care group. Twenty percent of KD025-treated patients experienced a 5 percent or larger decline in FVC, versus 44 percent of the supportive care group.

In addition, patients tolerated KD025 well. In fact, none experienced a serious adverse event.

Underscoring these results were that 90 percent of patients who received KD025 decided to continue the treatment beyond week 24.

Twenty patients completed 24 weeks of KD025 by the cut-off date of Feb. 1, 2018, versus nine In the supportive care group.

Kadmon is still enrolling participants in the trial. It anticipates recruiting 36 altogether. You can find more information here.

“We are pleased with today’s results, which demonstrate the activity and tolerability of KD025 in IPF, including in patients who have received prior therapy with approved agents,” Dr. Harlan W. Waksal, Kadmon’s president and CEO, said in a press release. “These findings support the therapeutic potential of ROCK inhibition in IPF and further validate Kadmon’s ROCK inhibitor platform, which is being applied across programs in fibrotic diseases as well as inflammatory diseases.”

“KD025 represents a novel mechanism of action in IPF by inhibiting ROCK, a central regulator of fibrosis that mediates several pro-fibrotic responses,” said Dr. Kevin F. Gibson, the trial’s lead investigator.

Kadmon plans to present the trial results at the American Thoracic Society International Conference in San Diego in May 2018.

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[lavishgail]

That's what I go through, during testing at the pulmonary's office I cannot blow my air out all the way I end up coughing or getting dizzy almost throwing up or feel like passing out I've tried it over and over and I still I can't do it. I have an appointment coming up Monday or Tuesday and we are going to do retesting again to see how well I'm doing fingers crossed I'm doing good. Thanks Gerald for putting these up very informative and very useful for me.

[lavishgail]

Gerald, I also bookmarked this so I can show my pulmonary doctor, I wonder what she would say about this, and I wonder where they will be bringing it in America?

[lavishgail]

Is this some sort of puffer they use? I don't quite understand what it is they're using? Can you explain that part thank you Gerald love Gail

[gerald]

Gail, their text does not really talk about how/where/when the material they use is applied. 

Your pulmonary doctor could probably contact them and get more information and find out if there is a next stage to the trial. (They may be looking for particpants in a next trial.)

[lavishgail]

Yes I did see that maybe I can be a participant wouldn't that be great? I'm going to speak with my doctor about this very fascinating and I have heard about it too. I know a couple of people that we're talking about this very very interesting thank you again.

[jarca]

From what i have found "KD025" is a pill to slow down IPF (idiopathic pulmonary fibrosis).
Espriet & Ofev were that kind of medication & this trial says they "The ongoing IPF trial (NCT02688647) is expected to include about 36 IPF patients who have previously been treated with Esbriet (pirfenidone) or Ofev (nintedanib), or both.
My guess is it being tested to replace espriet & ofev or for people who have taken those meds unsuccessfully? (those meds had a lot of side effects, i was affraid to try espriet when my Pulm wanted me to---plus it cost a fortune! at that time (2015)
(Gail, don't you take espriet?)
Here's the most recent info i could find. To me it looks like they are in the 2nd phase trial stage.

lungdiseasenews.com/2018/02/19/phase-2-trial-shows-kd025-has-potential-treat-ipf-patients/
(dated FEBRUARY 19, 2018 )
 

[lavishgail]

Jarca, no I'm not on that. But my breathing was a bit better overall the therapist said? They are doing everything differently now? I don't really understand, be4 My lungs were at about 60ish % now my therapist said they don't go by that anymore, they look at all the test ( breathing ) and tell you as an overall. I didn't understand? I'll wait till I see my oulm to explain to me? But she told me on my testing I was better by 1/2 what ever that means? Half of what? Am I up from 60% by half? So now am I at say 30% better? See what I mean? No clue, light is on mo one is home.
I'll keep you updated when I find out. They really don't know what I have, I just keep telling them when I have a lupus flare-up it attacks my lungs and I cannot breathe and if I don't get taken care of immediately it will go into my blood I will get sepsis and die. So I have to be on top of this at all times.

If I let my cough go long or if I feel very tired and not right and I don't get it checked out right away things go very quickly in my world it goes from a small cough to a full-blown pneumonia within 30 minutes from one line to the next, but I never know when that's going to happen it could be at any 5 minutes, so living this way it's very hard for me. I'll keep in touch, love Gail XXOO

[jarca]

Gail: I understand your confusion.
I used to get so confused that people would say they were at 18% FEV and they didn't need supplemental 02----where my FEV was at 58% & i needed to wear 02; confused the heck out of me!!!!
but my "DLCO" is at 38% (don't even get that reading unless put in 'glass chamber PFT"

anyway; sorry about the mix up. I thought that you took "espriet" (or one of those types of meds)---must have been someone else.
sorry i get confused

[lavishgail]

Oh no that's ok Jarca
. I do take to much meds. I'm on immune suppressants, one is celcept and the other is for my Psa. I forgot the name? , but it's often on tv if that helps. My Pulm, puts me on preds and if that's not helping also an antibiotic, all I have to do is call her and she puts it through immediately, because I know my body, as soon as my chest hurts just a little I know I'm getting my lung problem coming on real bad. And when I check my 02 even if it's at 96% that's when I noticed things are going down quickly because I'm the 9899 100% type of person. So when it's lower than that and goes lower as I go along then I know I'm getting very sick and that's what's been happening. So she put me on the steroids for now see how that goes.

My lupus doctor is going to take me off of the immune suppressants, and put me on something else in place because they are going to operate on me in a couple of weeks for my diverticulitis. So that worried is gone I don't have to worry that I'm not on something and that I get real sick.
Love you.