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Ironwood Commences Phase I Study on IW-6463 for CNS Disorders

Zacks Equity Research

Ironwood Pharmaceuticals, Inc. IRWD announced that it has initiated a phase I study on its orally administered, central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator, IW-6463. The candidate is currently being evaluated for the treatment of serious and orphan CNS disorders in healthy volunteers. Data from this study is expected during the second half of 2019.

IW-6463 is the first CNS-penetrant sGC simulator to enter clinical studies and is one of the five differentiated sGC stimulator programs.

The placebo-controlled phase I program will assess the safety, tolerability and pharmacokinetics of IW-6463 in healthy volunteers. IW-6463 will be examined in both single-ascending and multiple-ascending doses as part of the analysis.

Apart from IW-6463, Ironwood’s portfolio includes some other promising candidates like IW-3718, praliciguat and olinciguat. The company is enrolling patients in a phase III probe, evaluating IW-3718 for gastroesophageal reflux disease and a phase II study on olinciguat for sickle cell disease.

Two phase II studies examining praliciguat for diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF) are currently enrolling patients. Top-line data from both investigations are expected in the second half of 2019. Last September, the FDA granted a Fast Track designation to praliciguat as a treatment for HFpEF.

We would like to remind investors that Ironwood has one marketed product in its portfolio called Linzess (linaclotide). The drug is indicated for addressing irritable bowel syndrome (IBS) with constipation and chronic idiopathic constipation. The company co-develops and co-commercializes Linzess and also equally shares Linzess’ U.S. collaboration profits/losses as well as development costs with Allergan AGN.

Linzess witnessed solid sales in the first nine months of 2018, generating over half a billion dollars in revenues. The company is also developing Linzess for label expansion in several IBS indications.

Ironwood is heavily dependent on Linzess for growth and any regulatory setback related to it will weigh heavily on the stock as the rest of its pipeline is mostly in early to mid-stage development.

Shares of Ironwood have dropped 17.4% in the past year, narrower than the industry’s decline of 23.5%.

Zacks Rank & Stocks to Consider

Ironwood currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the same sector include Hikma Pharmaceuticals Plc HKMPF and Ionis Pharmaceuticals, Inc. IONS, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Hikma’s earnings estimates have been revised 6.1% upward for 2019 over the past 60 days. The stock has surged 37.5% in a year.

Ionis’ earnings estimates have moved 28% north for 2019 over the past 60 days. The stock has gained 7.3% in a year’s time.

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