Alba Therapeutics & Larazotide Acetate Update

I have written previously about the Celiac Disease drug therapies that are currently under development around the world. Alba Therapeutics is one company that is doing research and development with a drug called larazotide acetate. Here is an update from Alba posted yesterday on the PRNewsWire.

Alba Therapeutics Corporation announced today it will initiate further clinical studies for patients diagnosed with celiac disease with their lead compound, larazotide acetate. "Our most recent Phase IIb study, the largest trial with an investigational medication conducted in patients with celiac disease, was a randomized, double-blind, placebo controlled, dose ranging, multicenter study to determine the safety, tolerance and efficacy of larazotide acetate in 184 adults with controlled celiac disease during a gluten challenge. The data are promising and will be publicly presented at upcoming scientific meetings this spring," said Bruce Peacock, CEO of Alba Therapeutics. "Recently, Alba restructured to concentrate its efforts on advancing the clinical program for larazotide acetate, and we are now moving forward with initiating our next clinical trial in patients with celiac disease."

I had written earlier about the "restructuring" (layoffs) at Alba and have since been wondering what the status was at the company. It appears as if the company is moving forward, solely focused on using larazotide acetate as a treatment for Celiac Disease. Just as a side note - this drug and all the others I have written about are designed to be used in conjunction with the lifelong Gluten Free Diet. Their goal is to eliminate the damage done by unintentional Gluten exposure - not to allow the person to eat as much Gluten as they would like and then just pop a pill afterward.

Alba Contact Information
Contact: Wendy Perrow, MBA
Phone: 410-878-9850
E-mail: info@albatherapeutics.com
Web site: http://www.albatherapeutics.com

Alba Therapeutics Layoffs

I wrote about Alba Therapeutics last year in my series on Celiac Disease Drug Therapies currently under development. They are currently developing a drug for Celiac Disease called Larazotide acetate (formerly referred to as AT1001). There are 2 clinical trials underway for the drug to test it's effectiveness in treating Celiac Disease.

On Jan 23rd, 2009, the Baltimore Business Journal reported that Alba has announced layoffs due to the current economical crisis in the US. Twenty-two employees (nearly half of it's workforce) were let go on Jan 7th.

This can't be good news for the company that had high hopes to release the first Celiac Disease drug treatment.

Celiac Disease Drug Therapy: Alba Therapeutics

I have been doing some reading on recent research announced about Drug Therapy for Celiac Disease sufferers. There are currently 2 drugs under research and clinical trials at the moment. The first is called Larazotide acetate (formerly referred to as AT1001) and is being developed and studied by Alba Therapeutics in Baltimore, Maryland. I will write about the other in a separate post.

This drug would be used in conjunction with a Gluten Free diet to reduce Celiac Disease's "leaky gut" condition. "Leaky Gut" can also be described as intestinal permeability and is not only the cause of Celiac Disease issues but is also made worse by Celiac Disease. Two Clinical Trials have been conducted on this drug with promising results.

Trial 1 began in June 2007 and is still currently ongoing although not recruiting participants.
This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of Celiac Disease. The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.

Trial 2 began in February 2008 and is currently still recruiting participants.
The purpose of this research study is to look at how effective and safe larazotide acetate (AT-1001) is when it is given to subjects who have active Celiac Disease. A "leaky gut" is often found in Celiac Disease patients, and it is thought that the leakiness contributes to the disease, possibly by letting more gluten enter the body. Larazotide acetate (AT-100l) is an experimental drug that may possibly reduce gut leakiness and is being investigated to see if it can help people with Celiac disease along with a gluten free diet.

In an October 8th, 2008 press release, Alba presented new data from the two clinical trials listed above at the 2008 American College of Gastroenterology Annual Scientific Meeting. They confirmed that their studies have shown that Larazotide Acetate Prevented Immunologic Changes Induced by Gluten in Patients with Celiac Disease. Larazotide acetate has the potential to become the first approved medicine to treat Celiac Disease and has been granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA) for this indication. Both trials are in Phase II and expected to move to Phase III soon.

For more information about Alba Therapeutics and Larazotide acetate, see the following...
Click here for Alba's Web site
Phone: 410-878-9850
E-mail: info@albatherapeutics.com