Microbiome Report for the Week Ending 8-4-18

August 10, 2018

Azitra Awarded NIH SBIR Grant to Develop Microbiome – based Therapeutic for Netherton Syndrome

Azitra, Inc., today announced on 8/1/18 that the company has been awarded a $225,000 Small Business Innovation Research (SBIR) Phase I award (R43AR073562) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH). The grant will support development of Azitra’s skin microbiome therapeutic, AZT-02, a Live Biotherapeutic Product (LBP) for treatment of Netherton Syndrome (NS), a severely disabling orphan skin disease. Azitra’s Chief Scientific Officer, Travis Whitfill and The Jackson Laboratory’s (JAX) skin microbiome expert, Julia Oh, are the principal investigators on this grant.

AZT-02 is a proprietary strain of Staphylococcus epidermidis, a bacterium naturally found in the skin microbiome, engineered to express therapeutic levels of LEKTI protein. LEKTI is a protease inhibitor essential to maintaining skin structure, which is missing in patients suffering from NS.

NS is a genetic disorder caused by mutations in the SPINK5 gene, which provides instructions for making a protein called LEKTI. The disorder affects the skin, hair, and immune system. Approximately 1 in 200,000 newborns are born with the disease, and symptoms including red, scaly skin, typically become apparent in early childhood. Complications are frequent and newborns with the disorder are at risk of becoming dehydrated and developing infections in the skin or throughout the body (sepsis), which can be life threatening. There are currently few treatment options for NS.

Synthetic Biologics Announces Reverse Stock Split

Synthetic Biologics announced a reverse stock split of its issued and outstanding common stock, par value $0.001 per share, at a ratio of one (1) share of common stock for every thirty-five (35) shares of common stock, effective August 10, 2018 (the "Effective Date"). The Company's common stock will begin trading on a split-adjusted basis when the market opens on August 13, 2018.

Researchers Discover Link Between Probiotic Use and Brain Fogginess and Bloating in Some Subjects

In a published study of 30 patients, the 22 who reported problems like confusion and difficulty concentrating, in addition to their gas and bloating, were all taking probiotics, some several varieties.

When investigators looked further, they found large colonies of bacteria breeding in the patients' small intestines, and high levels of D-lactic acid being produced by the bacteria lactobacillus' fermentation of sugars in their food, says Dr. Satish S.C. Rao, director of neurogastroenterology/motility and the Digestive Health Clinical Research Center at the Medical College of Georgia at Augusta.

D-lactic acid is known to be temporarily toxic to brain cells, interfering with cognition, thinking and sense of time. They found some patients had two to three times the normal amount of D-lactic acid in their blood. Some said their brain fogginess -- which lasted from a half hour to many hours after eating -- was so severe that they had to quit their jobs.
The report in the journal Clinical and Translational Gastroenterology appears to be the first time the connection has been made between brain fogginess, bacterial overgrowth in the small intestine, high levels of D-lactic acid in the gut and probiotic use, Rao says.


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