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Re: WorstLuck post# 254113

Saturday, 01/04/2025 3:14:28 PM

Saturday, January 04, 2025 3:14:28 PM

Post# of 257448

It got 4 log in mice?


I was going from memory- it was a while ago. 2019?

This is Enanta's press release summary of the phase 1b trial;
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-positive-data-phase-1b-study-edp
"At Day 28, mean reductions in HBV DNA were 2.9, 3.3, and 0.2 logs IU/mL in the 200 mg, 400 mg and placebo groups, respectively, with a maximum reduction of 4.2 logs vs. 0.5 log in placebo. HBV DNA was below the lower level of quantitation (LLOQ) in 4 patients treated with EDP-514 compared to none in the placebo group. Mean HBV RNA reductions of 2.9, 2.4 and 0.3 logs IU/mL were observed in the 200 mg, 400 mg and placebo groups, respectively, with a maximum reduction of 4.8 logs vs. 1.9 logs in placebo. HBV RNA was undetectable at Day 28 in 8 patients treated with EDP-514 vs. none in placebo. As expected, no clinically significant changes in levels of HBsAg, HBeAg, or HBcrAg were observed."
It was a phase 1b. I think a phase 2 was planned and got tabled due to the suspension of EDP-721 and finances. IDK. In your opinion was it a success or a failure?



EDP 721- if memory serves was potentially effective- but very quickly determined to not be safe enough to pursue. I believe that was to lower the surface antigen.
https://www.fiercebiotech.com/biotech/enanta-dumps-oral-hep-b-program-after-safety-warnings-early-test
"Both Arbutus and Roche have also targeted PAPD5/7, with the former’s asset, AB-452, culled on preclinical safety signals and Roche’s agent was discontinued in phase 1."
Also; "Though [Enanta] reported no preclinical safety issues, the emergence of both preclinical and clinical safety signals for this class suggests PAPD5/7 may be an inherently difficult targets,” the firm mused in a note to clients." (my comment); I don't fault exploring the possibility of EDP-721, and feel that ceasing it quickly was a good call.

If you investigate you run the risk of failure.
Many big companies have failed- particularly in HCV. (If you wanted an example BMY/Inhibitex, JNJ bought ALIOS and Merck (MRK) shelled out $3.85 billion to buy Idenix Pharmaceuticals.)
Enanta's was a trifle in comparison.

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