Innovate Biopharmaceuticals Shows Larazotide is the First Drug, with its Novel Mechanism of Action of Re-normalizing the Intestinal Barrier, to Demonstrate Improvements in validated NASH Biomarkers and Endpoints in synergy with obeticholic acid, an FXR ag
Continued execution toward start of the first phase 3 celiac disease clinical trial in the current quarter with key sites for trial launch selected and active recruitment efforts underway
NASH Data Presentation at Analyst Meeting at Digestive Disease Week (DDW) conference on
- Active patient recruitment efforts underway
- Selected more than 100 clinical research sites to participate in our registration trial: CeD-LA-3001 Study: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide for Relief of Persistent Symptoms in Patients with Celiac Disease on a Gluten Free Diet.
- Immuno-oncology: started academic collaboration with Institut Gustave Roussy to study regulation of intestinal permeability and the gut microbiota using larazotide in immuno-oncology checkpoint inhibitor failure preclinical models
- Start of patient screening and randomization for the first phase 3 celiac disease trial
NASHdata presentation at Analyst Meeting at Digestive Disease Week (DDW) conference on May 20, 2019in San Diego
- Further updates on
NASHpathway for clinical development
- Continuation of pre-clinical studies for alcoholic steatohepatitis (ASH)
- Initiation of additional scientific and clinical collaborations
NASH Pre-clinical Data Highlights
In a 12 week preclinical study of larazotide acetate combined with obeticholic acid (OCA), data demonstrated statistically significant reductions in plasma total cholesterol (p<0.001), absolute (p<0.05) and relative liver weights (p<0.01), relative (p<0.001) and total liver cholesterol (p<0.001), and relative (p<0.01) and absolute liver triglycerides (p<0.001), when compared to vehicle control animals that did not receive any larazotide or OCA. The non-alcoholic fatty liver disease activity score (NAS score), the clinical measure of
Sandeep Laumas, M.D., CEO of Innovate, said, “The first quarter of 2019 was focused on continued preparation for the first celiac disease phase 3 clinical trial. Larazotide’s positive effect in a pre-clinical model has, for the first time shown, a novel mechanism for treatment of
2019 First Quarter Financial Results
As previously disclosed, as of
As previously announced, Innovate plans to host a conference call at
A live and archived audio webcast of the conference call will be available on the Events and Presentations page of Innovate’s corporate website at www.innovatebiopharma.com.
Nonalcoholic steatohepatitis (
Innovate is a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases. Innovate’s lead drug candidate, larazotide acetate, has a mechanism of action that renormalizes the dysfunctional intestinal barrier by decreasing intestinal permeability and reducing antigen trafficking, such as gliadin fragments in celiac disease, and bacterial toxins and immunogenic antigens in nonalcoholic steatohepatitis (
Forward Looking Statements
This press release includes forward-looking statements including, but not limited to, statements related to the development of drug candidates, our operations and business strategy, capital raising, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on management’s current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties, including, among others, those related to our ability to obtain additional capital on favorable terms to us, or at all, including, without limitation, to fund our current and future preclinical studies and clinical trials, including, without limitation, raising additional funds for our Phase 3 registration trial for INN-202, and the success, timing and cost of our drug development program and our ongoing or future preclinical studies and clinical trials, including, without limitation, the possibility of unfavorable new clinical and preclinical data and additional analyses of existing data, as well as the risks that prior clinical and preclinical results may not be replicated. These risks and uncertainties include, but may not be limited to, those described in our Annual Report on Form 10-K filed with the SEC on March 18, 2019, and in any subsequent filings with the SEC. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law.
Source: Innovate Biopharmaceuticals, Inc