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VIVUS' PAH Candidate Data Positive in Early Stage Study

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VIVUS, Inc. (VVUS - Free Report) announced positive preliminary data from a phase I study evaluating VI-0106, a proprietary soft capsule formulation of tacrolimus, for the treatment of pulmonary arterial hypertension (“PAH”).

Tacrolimus is approved since 1994 in the United States for lowering the risk of organ rejection in patients undergoing certain organ transplant and to treat atopic dermatitis. The drug has shown increased signaling through the bone morphogenetic protein receptor 2 pathway, which gets suppressed in PAH patients.

Data from the study demonstrated desirable pharmacokinetic (“PK”) profile for VI-0106, which supports continued evaluation of the candidate.

Shares of VIVUS have rallied 63.6% so far this year against the industry’s decline of 3.1%.

The phase I study is a two-part study for evaluating the PK profile of once-daily doses of VI-0106 in healthy participants. The first part was a dose-selection study, which evaluated three different doses of the candidate to identify a dose with most desirable PK profile. The second part evaluated the selected dose in healthy participants for steady-state (drug intake equals drug elimination) PK parameters.

Data from the study also showed that a once-daily dose of VI-0106 may maintain the low concentration of tacrolimus required for treating PAH with minimal monitoring of drug levels. The candidate also showed reduction in hospitalization rates and better functional class in three class 3 or 4 PAH patients under its compassionate use status.

VIVUS is developing VI-0106 under the FDA’s 505(B)(2) regulatory pathway, which allows the company to leverage clinical study data of tacrolimus, thus, accelerating the development process. The company is also looking to get Fast Track and Breakthrough Therapy Designation for the candidate.

Per the press release, the U.S. PAH market was worth $2.7 billion in 2015. With the approved drugs treating the symptoms of PAH and slowing disease progression, VI-0106 will be a first-in-class therapy with a potential to prevent disease progression. This may help the drug gain a significant portion of the PAH market upon successful development.

Zacks Rank & Stocks to Consider

VIVUS currently carries a Zacks Rank #3 (Hold).

Better-ranked stocks in the pharma industry include AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) , CollPlant Holdings Ltd. (CLGN - Free Report) and BioLineRx Ltd. (BLRX - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for AcelRx’s loss have narrowed 4.4% for 2018 and 15.3% for 2019 in the past 60 days. The stock has surged 77.8% year to date.

Estimates for CollPlant’s loss have narrowed 1.7% for 2018 and 1.4% for 2019 over the past 60 days.

Estimates for BioLineRx’s loss have narrowed 16.1% for 2018 and 15.2% for 2019 over the past 60 days.

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