AzurRx BioPharma, Inc. ( AZRX Quick Quote AZRX - Free Report) announced that it has initiated dosing in the phase IIb OPTION 2 extension study evaluating MS1819 using immediate release capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
Top-line data from the study is expected during the first quarter. Data from this study will help decide optimal doses and capsule types for development of MS1819 in potential late-stage study. The company expects an FDA meeting later to discuss the study design.
Shares of AzurRx soared 34.6% on Jan 21 following the announcement. In fact, shares of the company have gained 11.7% in the past year compared with the
industry’s 13.9% increase.
Please note that the phase II OPTION 2 study is comparing enteric capsules of MS1819 monotherapy with current standard of care for EPI. The OPTION 2 extension study was initiated following a protocol amendment request made by the company to the FDA for evaluating immediate release capsules of MS1819.
Data from previously completed phase II OPTION study demonstrated meaningful improvements in coefficient of fat absorption following treatment with MS1819 monotherapy.
The company is also evaluating MS1819 in combination with the current standard of care as a potential treatment for CF patients with severe EPI. The combination regimen has shown promise to bring clinically meaningful improvements in coefficient of fat absorption and relieve abdominal symptoms during interim study data presented last year at the 2020 Biotech Showcase Conference.
Earlier this month, the company signed a license agreement with privately-held First Wave Bio for the use of the latter’s patented and proprietary oral and rectal formulations of niclosamide. The company plans to develop these formulations for the treatment of immune checkpoint inhibitor-associated colitis and COVID-19 gastrointestinal infections. A clinical study is expected to start in the first half of 2021.
Zacks Rank & Stocks to Consider
AzurRx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same sector include
Blueprint Medicines Corporation ( BPMC Quick Quote BPMC - Free Report) , Clearside Biomedical, Inc. ( CLSD Quick Quote CLSD - Free Report) and Lexicon Pharmaceuticals, Inc. ( LXRX Quick Quote LXRX - 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
Blueprint Medicines’ loss per share estimates have narrowed from $6.77 to $6.55 for 2021 over the past 60 days. Shares of the company have increased 43% in the past year.
Clearside Biomedical’s loss per share estimates have narrowed from 38 cents to 30 cents for 2021 over the past 60 days. In the past year, shares of the company have rallied 34.1%.
Lexicon Pharmaceuticals’ loss per share estimates have narrowed from 66 cents to 63 cents for 2021 over the past 60 days. In the past year, shares of the company have gained 125%.
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