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AzurRx (AZRX) Pancreatic Insufficiency Study Meets Endpoints

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AzurRx BioPharma, Inc. announced positive results from a phase II study evaluating a combination regimen of its lead pipeline candidate, MS1819, as a potential treatment for severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Top-line data showed that treatment with the regimen achieved primary and secondary outcome measure endpoints.

The mid-stage study evaluated MS1819 in combination with the current standard-of-care, porcine-derived pancreatic enzyme replacement therapy (PERT). The study evaluated three escalating doses of MS1819 — 700mg, 1200mg, and 2240mg — once daily for 15 days per dosing level in combination with a stable dose of PERT. Data from the study showed that the treatment led to clinically meaningful improvement in coefficient of fat absorption (CFA), the study’s primary endpoint. Patients achieved 6.57% increase in CFA on average compared to baseline following treatment with the combo-regimen for six weeks.

Data from the study also demonstrated that the treatment led to mean body weight gain of 3.75 pounds, decline in stool weight by 164 grams/day and decrease in mean daily number of stools by 0.43. Data also suggests that MS1819 can improve fat absorption and other nutritional levels important for maintaining healthy weight, better pulmonary function and prolonged survival.

Shares of AzurRx gained 31.7% on Aug 18, following the promising study data readout. However, the company’s shares have declined 28.4% so far this year compared to the industry’s increase of 1%.

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Apart for this MS1819 combination regimen, AzurRx is evaluating the candidate as a monotherapy for treating EPI in CF patients. The company is currently developing a new enteric-coated microbead formulation for MS1819 monotherapy. It plans to initiate a bridging study in 2022 to establish safety and efficacy profile of the new formulation.

Previously, the company compared enteric capsules of MS1819 monotherapy with the current standard of care for EPI. However, the study evaluating this formulation of the candidate failed to meet the primary endpoint.

AzurRx has another candidate in its pipeline, niclosamide, a small molecule with anthelminthic, anti-viral and anti-inflammatory properties. In April, the company initiated a mid-stage study to evaluate the candidate in gastrointestinal disorders. It is also planning to start a phase Ib/II study to evaluate it in advanced stage oncology patients with immune checkpoint inhibitor-associated colitis and diarrhea.

Zacks Rank & Stocks to Consider

Currently, AzurRx has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech/drug sector include Horizon Therapeutics (HZNP - Free Report) , Repligen Corporation (RGEN - Free Report) and Aptose Biosciences (APTO - Free Report) . While Horizon sports a Zacks Rank #1 (Strong Buy), Repligen and Aptose currently carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days while that for 2022 have increased from $5.18 to $5.84 over the same period. The stock has risen 41% in the year so far.

Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 30 days while that for 2022 have increased from $2.57 to $3.02 over the same period. The stock has risen 32.9% in the year so far.

Aptose’s loss per share estimates for 2021 have narrowed from 76 cents to 68 cents in the past 30 days while that for 2022 have narrowed from 96 cents to 92 cents over the same period.


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