Seladelpar update

[DonnaBoll]

About a month or more ago, I wrote about this upcoming drug's potentially to be the next drug for second line treatment. By that I mean that for some reason someone was not responding to or not able to take Urso. 40% of patients are failed by Urso.

Cymabay, the pharma who manufacturers Seladelpar, is completely committed to work on drugs for PBC patients. Briefly, this drug works on certain receptors that are on the liver to decrease bile acids, decrease inflammation, and decrease serum IL-31 that causes the itch.

The trials used 500 patients. After 1 year the alk phos was decreased to 1.67 times ,the normal range, greater than 15% decrease in overall alk phos, and bilirubin was now less than 1 or 0. After 12 months use of this drug, 24% had a decrease in their alk phos.

Using the 'pruritus' scale, Cymabay wanted the results to be less than or equal to a 4. In 62% of the patients they had this overall response. The itch scale uses numbers 0-10. >9 is considered severe itching. I will post more information about this scale itself a bit late.

There was a 134 point reduction in the alk phos within 12 months' time. Even those who had alk phos less than 1.67 times the normal saw a decrease in their numbers.

In cirrhotic patients,25% of the patients had normalization - making their alk phos more normal.

There was a drop of 3.2 points using the 'itch scale' after 6 months on Seledelpar. The IL-31, I mentioned earlier that causes the itch was increased with patients taking Ocaliva.

96% of those in the trial agreed to continue to the long term research.

The very best news in their presentation about Seladelpar was that they are hoping to have it on the market 8/14/2024!!!!

There is hope for those who suffer with the dreaded itch. This drug could change lives!

[Gaspereaux]

i met a lady at the conference in Miami last week who had taken part in the clinical trial for Seladelpar. She was over the moon happy with the results and all her labs and her itching, or lack thereof. That is wonderful news.

[DonnaBoll Administrator in reply to Gaspereaux]

Two of the members from my previous group lived in the Miami area. They both had great results from the trial. Lisa or Emily???

[Gaspereaux in reply to DonnaBoll]

I think maybe Lisa? And I though a Marilyn…one was from Vero Beach…nice ladies!

[DonnaBoll Administrator in reply to Gaspereaux]

I thought I sent you a reply... now I can't find it... anyway, if It was Lisa I met her at a luncheon I held for my FL members at another member's home in Naples. She is a lovely woman! small world.... I still correspond with her on occasion.

[Giraffe44]

Hi Donna

Thanks for the post sounds very encouraging. Please can you clarify though- you refer to Seladelpar as a second line therapy- during the trial did participants take only Seladelpar or Seladelpar and Urso ?

[DonnaBoll Administrator in reply to Giraffe44]

Great question! They continued on their Urso as well. The Sepadelpar are added to it. This could certainly be a game changer for so many even this year. It really seemed to help with the itch as well as their numbers.

[Terri-Lynn]

Donna,

This is excellent news about Seledelpar. Hopefully, it will be help more people that Urso doesn't. So far, Urso has been working well for me. Monday, I'm have an Ultrasound and will see what my results are moving forward. I have lost 50 lbs and my current blood work is in normal range.

Please continue to keep us updated on the latest information. Very helpful.

[DonnaBoll Administrator in reply to Terri-Lynn]

We all celebrate with you!!! Good for you! How did you lose the weight? it's a ongoing struggle for me. Let us know about the ultrasound results.

[Gaspereaux in reply to Terri-Lynn]

That is awesome! Love all the positivity!

[DonnaBoll Administrator in reply to Gaspereaux]

Absolutely ! It makes all the difference what our attitude is in life. Some days just aren't what we what, but what we do with them is what counts.

[Terri-Lynn in reply to Terri-Lynn]

Losing weight was a challenge but kept a food, exercise, water, how I felt, log for 1 year reviewing it weekly. Sent a copy to my primary physician monthly to discuss with her. She suggested a few modifications along the way but understood it took time to make small changes throughout the year. If I wanted dessert, I would split it with someone and only would have open faced sandwiches with lettuce on top. Just simple changes. As I saw my weight loss, I became more assertive to reduce unhealthy carbs and sugars. I've been able to keep off the 50 lbs for 1 year now. I still have more to go but had 4 surgeries in 11 months so just needed some time. But plan to go back to it next month now that I can walk safely and balanced (2 knee replacements with 2 quad tendon tears..,yuk!)

[DonnaBoll Administrator in reply to Terri-Lynn]

Thank you for all your helpful tips. It is hard to be patient. I just got on the scale this morning and have lost 6 lbs since coming home from Scotland. Really trying to just take one meal at a time..... actually taking a 2 day seminar virtually next weekend hosted by Michelle May. I love her book Eat What You Love, Love What You Eat. It is simple changes but consistency. I had a knee replaced 2 years ago but at 74 I am so reluctant to go thru that again.. mobility has been a real issue for me of late impacting my ability to exercise as I'd like to - or should anyway. Thank you again!