- The company plans to add another study arm to its ongoing Phase 2b OPTION 2 clinical study which currently tests delayed release capsules
- If it receives FDA approval, AzurRx would be able to identify the optimal delivery method for its drug candidate MS1819 without significant extra costs or delays
- Enrollment in this arm of the study could begin as early as December 2020
AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, has submitted a protocol amendment request to the U.S. Food and Drug Administration that would allow it to test immediate release capsules of its exocrine pancreatic insufficiency drug candidate MS1819.
According to a company press release, if the amendment is approved, AzurRx would modify its current Phase 2b OPTION 2 trial of MS1819 in cystic fibrosis patients to add a study arm that uses immediate release capsules (https://ibn.fm/Ws66z). The existing arm of the study uses delayed release capsules. This would allow AzurRx to compare data from both arms to determine the best delivery method for its lead product.
“As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819,” AzurRx Chief Medical Officer Dr. James Pennington said.
The addition of a new arm would not impact the overall trial objectives, endpoints and statistical analysis of the Phase 2b OPTION 2 trial. “We are pleased to announce that our OPTION 2 trial is well ahead of schedule and almost fully enrolled without any safety issues being observed,” Dr. Pennington added. He also explained that determining appropriate dosage and delivery method is an important goal for any Phase 2 clinical trial, along with testing for safety and efficacy, before entering a Phase 3 program. He added that if the amendment is accepted by the FDA, AzurRx expects to begin enrollment into the new study arm as soon as December 2020.
AzurRx CEO James Sapirstein also said that the protocol amendment is a unique opportunity for the company to acquire valuable additional clinical data with no significant delays in the study timeline and no significant increase in overall costs.
The Phase 2b OPTION 2 trial consists of testing MS1819 doses in enteric capsule form with two concentrations: 2240mg and 4480mg. Initial results from the study indicated that the MS1819 non-porcine recombinant lipase is well tolerated at both dose levels and produces no adverse effects.
AzurRx is also conducting a Phase 2 cystic fibrosis combination trial, using MS1819 together with porcine pancreatic enzyme replacement therapy (“PERT”), the current standard of care. This study uses daily PERT doses in combination with different MS1819 dosages (700mg, 1120mg and 2240mg) and results made available so far have shown clinically meaningful improvements in subjects, with no adverse safety events.
According to Sapirstein, the company remains on target to release to line data for its Phase 2b trial in the first quarter of 2021. Top line data for the combination trial is expected in the second quarter.
Pending the Phase 2b trial outcome, the company will initiate a Phase 3 trial in cystic fibrosis and to this end, it has already identified and signed a binding letter of intent with a potential partner for the development and production of MS1819 for the study. Under the agreement, Asymchem, a leading global contract development and manufacturing service provider, will implement fermentation, verify protein expression, and fine-tune the technology for MS1819 production to help AzurRx optimize manufacturing and prepare for commercialization (https://ibn.fm/HJwT4).
AzurRx is determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, significantly reducing the pill burden of cystic fibrosis patients. The company believes that due to its safety and efficacy, its proposed therapy has the potential to improve the quality of life and help achieve healthier nutrition for many patients suffering from severe exocrine pancreatic insufficiency, including those with cystic fibrosis, chronic pancreatitis, pancreatectomy, and other indications.
NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX
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