Weight loss reported in the phase IIb trial was approximately 2 kg to 2.5 kg per patient at the two highest LX4211 doses compared to a slight weight gain for placebo. This is similar to what was seen in the SGLT-2 inhibitor drugs. There were also statically significant reductions in both systolic and diastolic blood pressure favoring LX4211.
HbA1c reduction increased steadily as the LX4211 dose increased but the amount of sugar secreted in the urine stayed fairly steady at about half the levels measured in the phase III studies of dapaglifozin and canaglifozin. This is a very interesting finding, which again, underscores why LX4211 could be safer than the other SGLT inhibitors.
There were no drug-associated severe adverse events reported in Lexicon's phase IIb trial. Targeting SGLT-1 has raised concerns about gastrointestinal side effects but nausea was reported in just 10% of LX4211-treated patients.
Lexicon plans to meet with the FDA soon to discuss a phase III program for LX4211. Studies should begin next year. The company has been open about wanting to find a partner, so I would expect a Big Pharma deal to be signed within the next few months.
Lexicon' pipeline outside of LX4211 includes a drug to treat carcinoid syndrome moving into phase III studies, and drugs to treat ulcerative colitis and irritable bowel syndrome in phase II.
Lexicon shares closed Monday at $2.55 but don't make the mistake of thinking of the company as a small-cap biotech stock. With 500 million shares outstanding, Lexicon's market cap is more than $1.2 billion. Lexicon required a lifeline during the market collapse of 2008-2009 that forced the company to push through a highly dilutive, below-market financing. Fortunately, the investment company that saved Lexicon remains a large shareholder and is not a flipper.
I usually balk at owning stocks with balance sheet weighed down with too many outstanding shares, but Lexicon is very attractive at its current valuation because LX4211 has real potential to be a blockbuster diabetes drug.
Rosenblum is long Lexicon.