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!
Ocaliva and side effects
