Innovate Biopharmaceuticals announced it dosed the first celiac patient for its study of larazotide acetate—the first celiac disease drug to get to the Phase 3 stage of a clinical trial. This is the only investigational celiac drug in Phase 3. There are other treatments in Phase 2 or earlier.

The Problem: Celiac Disease

This is a long-term autoimmune disorder that primarily affects the small intestine. Classical symptoms include gastrointestinal problems, such as chronic diarrhea, abdominal distention, loss of appetite, and others. The disease is caused by a reaction to gluten, a group of various proteins found in wheat and in other grains, such as barley.

It usually affects between 1 in 100 and 1 in 170 people. Rates vary around the world. In the U.S., it is thought to affect between 1 in 1750. About 85% of people affected are undiagnosed. It is estimated that 3 million Americas are struggling with the disease. There is no drug to treat celiac disease.

Background

This is the only celiac disease drug in Phase 3. There are other investigational drugs in Phase 2 or lower, including Nexvax2, a vaccine to treat celiac in Phase 2 developed by ImmusanT. However, it was discontinued due to disappointing results.

The Study

The study represents a Phase 3, randomized, double-blind, placebo-controlled, multi-center, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Innovate Biopharmaceuticals, the sponsor, has dosed the first of a total of 630 planned patients. The study will run through December 2021.

The Investigational Drug

Larazotide acetate or INN-202 is Innovate’s leading drug candidate for celiac disease (CeD) entering phase 3 clinical trials. INN-202 is a tight junction regulator, which helps restore “leaky” or open junctions to a normal state. In CeD patients, ingestion of gluten causes disruption or opening of the tight junctions. The open junctions cause an inflammatory cascade within the intestinal epithelium that eventually destroys the intestinal villi, decreasing the surface area for absorption of nutrients, thus leading to a variety of diseases. When ingested prior to a meal, larazotide may help keep the tight junctions closed, thus reducing the intestinal-inflammatory process in response to gluten.

Intestinal permeability is thought be involved in a variety of GI and autoimmune diseases and using a safe, non-absorbed drug like larazotide with more than 800 patient exposure, can allow for rapid proof-of-concept clinical trials.

See the link for a video of the sponsor’s investigational drug.

The drug was developed by Alba Therapeutics. In 2016, Alba licensed the drug to Innovate Biopharmaceuticals.

Clinical Investigator Sites

Innovate Biopharma doesn’t list the names of their clinical research sites for this study. They do list a contact Anh Thu Nguyen and their CEO is Sandeep Laumas, MD.

The Commercial Sponsor: Innovate Biopharmaceuticals

A clinical-stage, emerging biopharma focused on novel gastroenterology medicines. Publicly traded, they are based in the Research Triangle Park (RTP) region of North Carolina (Raleigh).  A micro-cap stock, they are currently priced at under $1 at just over .88 per share. They are forecasted to lose about $13 million and they have the same amount as cash in the bank. 43.2% of their shares held by insiders. The biggest insiders are Jonathan P. Clark (285K shares) and Tandon Jawahar, COB (125K shares).

Formed in 2012, they initiated IPO to float stock on market in 2016. Their 52 week high/low is $9.60 and $0.72.

After a TrialSite News research team review of their latest SEC 10-K, we found that on January 29, 2018, the company completed a reverse merger with “Monster Digital, Inc.). Typically reverse mergers are a mechanism for a group to gain public company status in an accelerated and economical manner. As a public company, Innovate can potentially commands more capital-raising options. However, once-public Innovate has many more reporting requirements, and typically reverse mergers work best with companies with strong financial foundation. This is not the case here.

Stock analyst BioSci Capital Partners, a regular on investing website Seeking Alpha summarizes the potential of this company:

  • Strong growth potential but highly volatile
  • Two highly promising molecules could catapult the shares higher
  • Positive Phase 2b data and ongoing Phase 3 study now for INN-202
  • Potential for INN-217 in NASH market

Pipeline

The company does have a pipeline of drug candidates for celiac disease, nonalcoholic steatohepatitis (NASH), alcoholic steatohepatitis (ASH), Crohn’s disease (CD) and ulcerative colitis (UC). Their lead program, INN-202 (larazotide acetate or larazotide) has entered Phase 3 for celiac disease, which is promising for the company. Approximately $3 million struggle with celiac disease, and if the company can demonstrate the effectiveness and safety of INN-202 and secure FDA approval then they have the only treatment for celiac disease on the market.

Risk

As with most emerging biopharma’s there is incredible risk with investing in these ventures. One should seek out the advise and counsel of knowledgeable, objective, and unbiased professionals prior to investing in any emerging biopharma venture.

Call to Action: Do you or a loved one have celiac disease? It is practical to monitor this clinical trial as Innovate Biopharmaceuticals demonstrates efficacy and safety by 2021 and if the investigational drug is approved by the FDA, then probably by 2022 the very first celiac drug would be available on the market. Are you interested in clinical investigational sites that focus on celiac? TrialSite News maintains the TrialSite Network, a global list of investigational sites and can help you find the research sites that can support your needs.

Source: Beyond Celiac

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