Arena's (ARNA) Heart Failure Candidate Gets Fast Track Status
Zacks Investment Research | Jan 16, 2020 08:16PM ET
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) announced that the FDA has granted Fast Track designation to its adrenergic receptor antagonist, ADP418, for treating decompensated heart failure (“DHF”). The company initiated a phase I study to evaluate ADP418 in DHF patients in the fourth quarter of 2019.
Shares of Arena have increased 7.2% in the past year against the industry ’s decrease of 2.8%.
The company’s pipeline currently consists of two key candidates, namely etrasimod (autoimmune diseases) and olorinab (pain and fibrotic diseases).
A pivotal phase III study – ELEVATE UC 52 – is evaluating etrasimod in patients with moderately-to-severely active ulcerative colitis. The phase IIb ADVISE study is evaluating the candidate atopic dermatitis patients. The company recently initiated the phase IIb/III CULTIVATE study for treating patients with Crohn's disease. It also plans to initiate two new mid-stage studies, which will evaluate etrasimod in eosinophilic esophagitis, an inflammatory gastrointestinal condition, and alopecia areata, an autoimmune disorder causing hair loss.
A phase II CAPTIVATE study is evaluating olonarib as a treatment for abdominal pain associated with irritable bowel syndrome.
The company expects study data readouts from these mid and late-stage studies in 2020 and 2021.
The company is also focusing on expanding its pipeline. It plans to file a new investigational new drug application every year over the next five years to support initiation of clinical studies on new candidates or indications. Earlier this month, it entered into a strategic multi-year partnership with privately-held Beacon Discovery. Per the terms of the deal, while Beacon will be responsible for drug discovery using its proprietary GPCR discovery platform, Arena will develop and commercialize promising novel compounds as a treatment for a variety of immune and inflammatory diseases.
Meanwhile, Arena has announced that it will form a new subsidiary, Arena Neuroscience. The subsidiary will focus on programs and platforms to develop therapies targeting neuroinflammation indications.
We would like to remind investors that in January 2019, Arena out-licensed the global rights to its pulmonary arterial hypertension candidate ralinepag to United Therapeutics (NASDAQ:UTHR) . The deal significantly boosted Arena’s cash resources.
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