AzurRx (AZRX) Pancreatic Insufficiency Study Achieves Goals
AzurRx BioPharma, Inc. AZRX announced the positive results of a Phase II study evaluating a combination regimen of its lead pipeline candidate, MS1819, as a potential treatment for severe exocrine pancreatic insufficiency (PEI) in patients with cystic fibrosis (CF). Leading data showed that treatment with the diet met both primary and secondary endpoints.
The mid-term study evaluated MS1819 in combination with current standard porcine pancreatic enzyme replacement therapy (PERT). The study evaluated three escalating doses of MS1819 – 700 mg, 1200 mg and 2240 mg – once daily for 15 days per dosage level in combination with a stable dose of PERT. Study data showed that the treatment led to a clinically significant improvement in fat absorption coefficient (CFA), the primary endpoint of the study. Patients achieved an average 6.57% increase in CFA from baseline after treatment with the combined regimen for six weeks.
The study data also showed that the treatment resulted in an average body weight gain of 3.75 pounds, a decrease in stool weight of 164 grams / day, and a decrease in the average daily number of stools by 0.43. Data also suggests that MS1819 may improve fat absorption and other nutritional levels important for maintaining a healthy weight, better lung function, and prolonged survival.
AzurRx shares gained 31.7% on August 18, following a promising reading of the study’s data. However, the company’s shares are down 28.4% so far this year compared to the industry1% increase.
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Apart from this MS1819 combination regimen, AzurRx is evaluating the candidate as monotherapy for the treatment of PEI in patients with cystic fibrosis. The company is currently developing a new formulation of enteric-coated microbeads for MS1819 monotherapy. It plans to launch a transition study in 2022 to establish the safety and efficacy profile of the new formulation.
Previously, the company compared MS1819 enteric capsules as monotherapy with the current standard of care for EPI. However, the study evaluating this formulation of the candidate did not meet the primary endpoint.
AzurRx has another candidate in its pipeline, niclosamide, a small molecule with anthelmintic, antiviral and anti-inflammatory properties. In April, the company launched a mid-term study to assess the candidate in gastrointestinal disorders. He also plans to start a phase Ib / II study to evaluate it in advanced oncology patients with colitis and diarrhea associated with immune checkpoint inhibitors.
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Zacks ranking and actions to take into account
Currently, AzurRx has a Zacks Rank # 3 (Hold).
Some top-ranked stocks in the biotech / medicine sector include Therapeutic horizon HZNP, Repligen Corporation RGEN and Aptose Biosciences APTO. While Horizon sports a Zacks Rank # 1 (strong buy), Repligen and Aptose currently sport a Zacks Rank # 2 (buy). You can see The full list of today’s Zacks # 1 Rank stocks here.
Horizon’s earnings per share estimate for 2021 has fallen from $ 3.62 to $ 4.46 in the past 30 days, while those for 2022 have fallen from $ 5.18 to $ 5.84 in the last 30 days. the same period. The stock has risen 41% on the year so far.
Repligen’s earnings per share estimate for 2021 has fallen from $ 2.26 to $ 2.76 in the past 30 days, while those for 2022 have fallen from $ 2.57 to $ 3.02 during the last 30 days. same period. The stock has risen 32.9% in the year so far.
Aptose’s loss per share estimates for 2021 have fallen from 76 cents to 68 cents in the past 30 days, while those for 2022 have fallen from 96 cents to 92 cents over the same period.
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