VIVUS Announces Positive Results from a Phase 1 Clinical Trial of VI-0106

VIVUS (Nasdaq:VVUS) a biopharmaceutical company, today announced positive preliminary results from a Phase 1 clinical study evaluating the pharmacokinetic (PK) profile of its VI-0106 in healthy volunteers.  VIVUS is developing VI-0106, a proprietary soft capsule formulation of tacrolimus for the treatment of pulmonary arterial hypertension (PAH), a degenerative disease that makes it difficult for the heart to pump blood through the lungs to be oxygenated and may ultimately lead to heart failure.

As quoted in the press release:

Current PAH treatment options only address the symptoms, slowing but not preventing disease progression. New therapies that address the underlying cause of disease are urgently needed.  The U.S. Food and Drug Administration (FDA) approved tacrolimus in 1994 for use in lowering the risk of organ rejection in patients undergoing kidney transplant, and the drug is currently indicated for use in additional organ transplant settings and to treat atopic dermatitis.  Tacrolimus has been shown to increase signaling through the bone morphogenetic protein receptor 2 (BMPR2) pathway, which is down-regulated in PAH patients.

“The positive Phase 1 data from this study of VI-0106 in healthy volunteers support continued evaluation of this investigational candidate in PAH patients,” said John Amos, Chief Executive Officer at VIVUS.  “The worldwide and U.S. markets for PAH therapies were approximately $4.5 billion and $2.7 billion, respectively, in 2015, and we believe that VI-0106 has the potential to capture significant market share as a first-in-class therapy with a novel mechanism of action.  We are exploring a variety of strategies for leveraging this collection of data to advance this program consistent with our goals of working toward profitability and reducing our corporate debt.”

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