Horizon Therapeutics plc HZNP announced that it has enrolled the first patient in a pivotal phase IIb study evaluating its lysophosphatidic acid receptor 1 (LPAR1) antagonist, HZN-825, for the treatment of idiopathic pulmonary fibrosis (“IPF”).
The above study will investigate the safety, efficacy and tolerability of HZN-825 in slowing the decline of lung function due to inflammation and fibrosis caused from IPF. The study’s primary endpoint is to see the change in forced vital capacity after 52 weeks of treatment.
Secondary endpoints of the study are – the 6-Minute Walk Test (6MWT), the King’s Brief Interstitial Lung Disease (K-BILD) Questionnaire, the rate of hospitalization caused due to respiratory distress, as well as a composite endpoint of progression-free survival.
Per the company, around 100,000 people in the United States live with IPF, and patients with the disease have a median survival of less than five years. Hence, if successfully developed and upon potential approval, HZN-825 can help in treating people with this rare and progressive lung disease.
Shares of Horizon have rallied 15.9% in the past year against the industry’s decline of 39.6%.
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The April 2020 acquisition of privately held biopharma company, Curzion Pharmaceuticals, Inc., added HZN-825 to Horizon’s portfolio.
HZN-825, an oral selective LPAR1 antagonist, is also being evaluated in another mid-stage study for treating patients with diffuse cutaneous systemic sclerosis, a subset of systemic sclerosis.
In November 2021, Horizon enrolled the first patient in the pivotal phase IIb study evaluating HZN-825 for treating diffuse cutaneous systemic sclerosis.
Following encouraging efficacy and safety data from the phase IIa study on HZN-825 in patients with early diffuse cutaneous systemic sclerosis, Horizon initiated a pivotal phase IIb study on the same.
Horizon reports financial results under two segments, namely, Orphan (previously known as the Orphan and Rheumatology segment) and Inflammation (previously known as the primary care segment). The company’s portfolio of marketed drugs has been witnessing a solid uptake.
Sales in the Orphan segment are being driven by the strong uptake of Tepezza as well as the continued growth of Krystexxa, Ravicti, Procysbi and Actimmune.
The company is also planning to initiate an exploratory study on Tepezza in diffuse cutaneous systemic sclerosis shortly.
Zacks Rank & Stocks to Consider
Horizon currently carries a Zacks Rank #4 (Sell).
Top-ranked stocks in the biotech sector include Cara Therapeutics, Inc. CARA, Alkermes plc ALKS and AnaptysBio, Inc. ANAB, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Cara Therapeutics’ loss per share estimates have narrowed 1.3% for 2022, over the past 60 days.
Cara Therapeutics’ earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Alkermes’ earnings estimates have been revised 1.4% upward for 2022 over the past 60 days. The stock has increased 17.9% in the past year.
Alkermes’ earnings have surpassed estimates in each of the trailing four quarters.
AnaptysBio’s loss per share estimates have narrowed 0.3% for 2022, over the past 60 days. The stock has rallied 33% in the past year.
AnaptysBio’s earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
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