Gastroparesis, which literally means paralyzed stomach, is a disorder in which the stomach takes too long to empty food from the stomach into the small intestine. Diabetes is the most common cause of gastroparesis, and it is estimated that about 12% of patients with diabetes suffer from gastroparesis worldwide.
The only medication approved by the FDA for treating gastroparesis - Reglan (metoclopramide), carries a black box warning because of the danger of serious side effects like tardive dyskinesia. There is currently a large unmet medical need for the treatment of gastroparesis due to the lack of safe and effective therapies.
Developing a new drug for diabetic gastroparesis is a North Carolina based clinical stage biotechnology company, Tranzyme Inc. (TZYM).
For readers who are new to Tranzyme, here's a brief overview of the company's pipeline and the upcoming catalysts to watch out for...
The company's lead product, TZP-102, designed using its proprietary drug discovery technology namely, Macrocyclic Template Chemistry (MATCH), is in phase 2b clinical development for diabetic gastroparesis. TZP-102 has a fast track designation granted by the FDA for the treatment of gastroparesis in diabetic patients.
A phase 2b trial of TZP-102 was initiated last October. The study evaluates two dose levels of TZP-102 and placebo administered orally, once daily, for 12 weeks in diabetic patients with a history of moderate to severe symptoms of gastroparesis.
Tranzyme expects to report top-line data from the first 12-week phase 2b trial by year-end 2012.
The company's second 12-week phase 2b trial of TZP-102, dubbed DIGEST, is enrolling patients, and top-line results from this trial are expected to be announced in the first half of 2013.
In addition to diabetic gastroparesis, the company plans to evaluate TZP-102 in the treatment of other upper gastrointestinal disorders such as functional dyspepsia and refractory gastroesophageal reflux disease.
Also in the company's pipeline are two preclinical drug candidates - TZP-201 for the treatment of various forms of moderate-to-severe diarrhea and TZP-301 for the treatment of obesity and other metabolic diseases.
In March of this year, Tranzyme shares took a hit after its bowel drug candidate - Ulimorelin, disappointed in a phase 3 trial. Ulimorelin was intended to accelerate gastrointestinal recovery in subjects who had undergone partial bowel resection. The company has stopped development and regulatory activities for Ulimorelin.
A quick look at the company's balance sheet...
Since inception in 1998, Tranzyme has incurred significant operating losses. Currently no revenue is generated from sales, and the company's revenue stream consists of licensing and royalty revenue and fees for research services from license or collaboration agreements.
In the third quarter ended September 30, 2012, the company incurred a net loss of $3.95 million or $0.16 per share on revenue of $1.82 million. This compares with a net loss of $6.41 million or $0.26 per share on revenue of $2.65 million in the year-ago third quarter.
The company ended Q3, 2012 with cash and cash equivalents of $40.8 million.
Tranzyme went public in April 2011 offering its shares at $4.00 each. The stock has thus far hit a 52-week low of $1.68 and a 52-week high of $5.64. TZYM closed Monday's trading at $4.19, up 3.46%.
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