Dive Brief:
- San Diego-based biotech Neothetics lost most of its value in Monday trading, dropping nearly 70% to trade below $1 per share.
- The clinical-stage drug developer announced negative top-line results for a Phase 2 proof-of-concept study for its only clinical-stage candidate, LIPO-202.
- LIPO-202 is an injectable formulation of the beta2-adrenergic receptor agonist salmeterol xinafoate, one of the active ingredients in GlaxoSmithKline’s blockbuster respiratory drug Advair (fulticasone/salmeterol).
Dive Insight:
Neothetics disappointed investors Monday morning when the little biotech disclosed its only drug had failed to show any efficacy or difference from placebo in treating submental fat, or double chin.
The trial followed 162 patients for eight weeks, in which patients were given either the drug or placebo via 30 subcutaneous injections.
Management called the trial results "unambiguous" and "disappointing." Neothetics only has about $9.7 million in cash on hand and is now trying to "determine the path forward for the company," said Kim Kamdar, a member of the board of directors, in a statement.
Neothetics was pursuing the Advair reformulation for the treatment of double chin because preclinical studies showed beta2-adrenergic receptors on fat cells can be triggered to jumpstart metabolism of triglycerides.
While the idea of repurposing an active ingredient from a respiratory drug might seem odd, plenty of other drugs have been rejiggered for totally different uses. Famously, Pfizer was studying Viagra as a heart drug before discovering its benefits for erectile dysfunction.
As for the double chin market, the only treatment currently available is Allergan’s Kybella (deoxycholic acid). The drug, far from Allergan’s top-seller, brought in only $15.1 million during the first quarter, up 34% year-over-year. The specialty pharma said sales of the drug were beginning to increase due to the launch of direct-to-consumer advertising.