InvestorsHub Logo
Followers 29
Posts 2647
Boards Moderated 0
Alias Born 07/26/2016

Re: None

Friday, 01/07/2022 1:48:13 PM

Friday, January 07, 2022 1:48:13 PM

Post# of 402865
If Leo and board/family shares are totaled up at less than 15 million or so (I have not done an exact estimate) how hard would it be simply outvote them and get a new CEO, etc. How can share owners oust him/them? I was never hugely bothered by the million or more on annual salaries, and failures in the prurisol and covid trials (despite my feeling that an injection addressing early phase patients instead of very sick ones on IVs, would have been so much more reasonable) when the many potentials remained realistic. What has bothered me has been the lack of creativity and verifiable forward motion (still no injection, pill or other treatment variants so necessary to compete in the various markets (IBD, skin, anti-MRSA bacterial, wide-scoped anti-virals for Brilacidin, etc.), not even mentioning kevetrin. And we continue to endure the constant time loss of patent value with almost embarrassing PRs. Couldn't message board longs martial 20-30 million shares? I've heard this mused about with other troubled little bios, but I've never seen anything happen. But here we are at a nickel a share and only the Alfasigma tests as a real potential. And there is no certainty here, only a good chance of good things happening, i.e. FDA test cycle participation. I know B for OM could happen, but there is nothing of substance of which I am aware, just hopes, as I see it and the same for ABSSSI. Just hopes. I really hope my perspective is much too negative and unfair to IPIX. I really hope that.

I reached this deeper phase of pessimism this morning as I opened my computer and read of another immunologic going to an FDA Ph3 for ulcerative colitis. I wish them well. See below:

January 6, 2022
Maintenance of Clinical Remission Observed With Mirikizumab in Ulcerative Colitis Trial
Brian Park, PharmD
Share on Facebook
Share on Twitter
Share on LinkedIn
Share on Reddit
Print
Share by Email
ulcerative colitis
Mirikizumab is an investigational anti-IL-23p19 monoclonal antibody. Credit: Shutterstock.
Positive results were announced from a phase 3 study evaluating mirikizumab, an investigational anti-IL-23p19 monoclonal antibody, as maintenance therapy in patients with moderately to severely active ulcerative colitis (UC).

The multicenter, randomized, double-blind, placebo-controlled maintenance study LUCENT-2 (ClinicalTrials.gov Identifier: NCT03524092) evaluated the efficacy and safety of mirikizumab in UC patients who achieved clinical response in the 12-week LUCENT-1 induction study (ClinicalTrials.gov Identifier: NCT03518086). Patients were randomly assigned to mirikizumab maintenance dosing or placebo for 40 weeks. The primary endpoint was clinical remission based on modified Mayo Score at week 40.

Results showed that a statistically higher proportion of patients treated with mirikizumab achieved clinical remission at 1 year compared with those who received placebo (P <.001). Mirikizumab also met all key secondary endpoints with a significantly higher proportions of patients achieving endoscopic remission, corticosteroid-free remission, resolution or near-resolution of bowel urgency, improvement in endoscopic histologic intestinal inflammation and maintenance of remission, and greater reduction from baseline in bowel urgency symptoms at 1 year, compared with placebo (all P <.001).

Today’s top picks on the Haymarket Medical Network
A Deep Dive Into the Liver Manifestations in Rheumatic Diseases
Veterans With High Blood Glucose, Insulin Use, Risk COVID-19 Complications
Unique Risks in People With Familial Hypercholesterolemia and COVID-19
CONTINUE READING
The overall safety profile of mirikizumab was consistent with that seen in previous studies for UC. The most common adverse events reported were nasopharyngitis, arthralgia and exacerbation of UC.

“In this maintenance study, treatment with mirikizumab demonstrated clinically meaningful and statistically significant improvements in clinical, endoscopic and histologic measures, including reduction of bowel urgency – a novel endpoint in the LUCENT program,” said Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine, Chief of the Dr Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai. “Bowel urgency is one of the most bothersome and disruptive symptoms people living with ulcerative colitis experience, and the LUCENT program leveraged an innovative and systematic patient-centric approach to assess patients’ symptoms.”

Mirikizumab is also being evaluated in the LUCENT-3 trial (ClinicalTrials.gov Identifier: NCT03519945), an open-label extension study for eligible patients who have participated in the mirikizumab UC clinical development program.

The Company intends to submit a Biologics License Application to the Food and Drug Administration (FDA) for the UC indication in the first half of 2022. Phase 3 trials investigating mirikizumab as a treatment for Crohn disease are ongoing.

Reference
Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022. News release. Eli Lilly and Company. Accessed December 15, 2021. https://www.prnewswire.com/news-releases/mirikizumab-demonstrates-superiority-over-placebo-in-phase-3-maintenance-study-in-ulcerative-colitis-supporting-regulatory-submissions-in-2022-301444707.html.
This article originally appeared on MPR

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent IPIX News