Lantibio, Inc. Announces the Initiation of Clinical Trials in

Press Release:

Lantibio, Inc. Announces the Initiation of Clinical Trials in Dry Eye Syndrome

Press Release
News Article March 2005

CHAPEL HILL, N.C., March 14 /PRNewswire/ -- Lantibio, Inc. announced today that the United States Food and Drug Administration (FDA) accepted an Investigational New Drug Application (IND) for the human clinical testing of Moli1901 for the treatment of dry eye syndrome. The company expects to commence a Phase I clinical study with Moli1901 in the first quarter of 2005.

Lantibio also announced the formation of its scientific advisory board for ophthalmic development. Chairman; Roger Vogel, MD, Rx Development Resources, Inc., Tampa, Fla., other members include: Gary Foulks, MD, FACS, Professor, Department of Ophthalmology & Visual Sciences, University of Louisville, KY, Edward J. Holland, MD, Director of Cornea and External Disease, Cincinnati Eye Institute, Professor of Clinical Ophthalmology, University of Cincinnati, OH and Andrew J.W. Huang, MD, MPH., Associate Professor, Director of Cornea & Refractive Surgery University of Minnesota Fairview University Medical Center.

In dry eye syndrome, it is hypothesized that Moli1901 administered via ocular instillation will hydrate the surface of the eye preventing irritation, relieving discomfort, and ultimately reversing or preventing long-term ocular injury.

"We are excited to advance the development of Moli1901 for a second indication and we look forward to starting the first ocular clinical trial with our lead molecule," said Dr. Luis Molina, President and CEO of Lantibio, Inc. "The knowledge gained from our experience with the development of Moli1901 for cystic fibrosis (CF) was integral to our understanding of the molecule. This knowledge led to this new IND in dry eye syndrome," added Terry Laliberte, Director of Development.

The National Eye Institute/Industry Sponsored Workshop defines dry eye syndrome or keratoconjunctivitis sicca as a "disorder of the tear film due to tear deficiency or excessive tear evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of discomfort."

The most common causes of dry eye syndrome are: Sjogren's syndrome, hormonal changes in menopause, ocular surgery and environmental factors such as dust and pollutants.

The hallmark symptoms in Sjogren's syndrome are dry eyes and dry mouth. It is one of the most prevalent autoimmune disorders, striking as many as three million Americans. Symptoms of dry eye syndrome include burning, itching, irritation, photophobia, and a feeling that there is a foreign body in the eye. If left untreated, it can cause permanent damage, including impaired vision.

In 2003, Morgan Stanley Research estimated the prevalence of dry eye syndrome in the United States at 5.5 million diagnosed cases. Most sufferers are women and prevalence increases with age. More than 90% Sjogren's syndrome sufferers are women and the average age of onset is in the late 40's.

Moli1901 for the treatment of CF has been licensed to AOP Orphan Pharmaceuticals AG, Vienna, Austria for European territories. AOP is currently conducting a Phase II trial in Germany with Moli1901 Solution for Inhalation.

CF is a genetic disease characterized by the chronic formation of mucus plugs in a patient's airways, caused by abnormal salt and water transport. Moli1901 may normalize the mucus composition in the lungs by activating an alternative salt channel present in the airway.

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