If a new product cannot even significantly outperform a placebo on these lax endpoints, it is nothing to cheer for. ( NASDAQ: LBPS) is a UK-based clinical stage pharmaceutical company developing a novel class of drugs termed live biotherapeutic products (‘LBPs), derived from the microbiome. Given the Phase 2 results we have seen it is clear to me that even if this product makes it to market, it will not make a significant change to how we treat IBS. It was clear from the press release at the time however that they were banking on the old pharma company strategy of getting barely significant results to bring the product to market. At the time there was a real disagreement about how to proceed and I'm not sure they have made up their mind yet. 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces new fecal microbiome analyses from the completed Phase II trial of Blautix (MRx1234) as a treatment for irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D). Some of them had been working on the platform since 2014 so their disappointment is understandable. 4D Pharma is preparing to move its irritable bowel syndrome drug, Blautix, into a phase II clinical trial, The Press and Journal reports. Not surprisingly they were not very happy with the trial results and they explicitly said that they agreed with my entire analysis of the results. a Phase I/II study of MRx-4DP0004 in asthma, and Blautix® in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. They had read my trial report from last year and in December 2020 I spoke to several representatives of the company including the head of development. 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs. I guess it is safe to mention now but I actually was in a few Teams meetings with 4D Pharma about their Blautix trial.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |