Ionis (IONS) Stock Falls Despite Positive Inotersen Data
Zacks Investment Research | May 16, 2017 05:57AM ET
Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) announced that the phase III study NEURO-TTR on inotersen (IONIS-TTRRx) in patients with familial amyloid polyneuropathy (FAP) met both primary endpoints.
Inotersen is potentially a first-in-class and best-in-class candidate being developed for the treatment of all forms of transthyretin, or TTR, amyloidosis.
The 15 months study demonstrated that the patients who were treated with inotersen experienced a significant benefit compared with placebo in the modified Neuropathy Impairment Score. The study met both primary endpoints and statistically significant differences were also observed at both end points.
Despite meeting the primary endpoints, the shares of the company declined by about 6.75%. This is because the data from the study made the investors anxious about the drug’s safety. Notably, Ionis’ share price has decreased 8.2% year to date against the Zacks classified Medical-Drugs industry’s gain of 7.2%.
Additionally, the study had some serious side effects. The adverse effects were seen more commonly with inotersen than in the placebo. In fact, three study participants developed thrombocytopenia among which two patients recovered but one died from intracranial hemorrhage and another patient stopped taking Inotersen due to non-serious thrombocytopenia.
Four other patients who were treated with inotersen stopped taking the treatment due to a renal observation. Two amongst those met a predefined renal stopping rule and two others experienced serious renal adverse events, one of whom experienced chronic renal insufficiency. One placebo-treated patient also met a predefined renal stopping rule. All five serious adverse events occurred before enhanced monitoring was fully implemented.
Ionis stated that a review of the safety data is ongoing.
Currently, long-term safety and efficacy data with inotersen are being collected in an open-label extension of the phase III NEURO-TTR study. Moreover, review of the full data package from the NEURO-TTR study by Ionis and its partner GlaxoSmithKline plc (NYSE:GSK) is ongoing and detailed results from the study will be presented at an upcoming medical meeting and submitted for publication in a peer-reviewed medical journal.
Both Ionis and GlaxoSmithKline are preparing to file for regulatory marketing applications for inotersen, going forward. GlaxoSmithKline has the option to license inotersen following review of additional data and prior to the submission of regulatory applications.
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Zacks Rank & Stocks to Consider
Ionis currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) and MEI Pharma, Inc. (NASDAQ:MEIP) . Both of them sport a Zacks Rank #1 (Strong Buy). You can see .
VIVUS’ loss per share estimates narrowed from 502 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates narrowed from loss per share of 1 cent to gain per share of 1 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.
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