The MAPLE study used a modified manufacturing process and demonstrated decreased intraocular inflammation
Previously reported positive Phase 3 results demonstrated the potential for abicipar to be the first anti-VEGF therapy to maintain initial vision gains in all patients on a true fixed 12-week dosing interval
Abicipar BLA submission to the FDA planned for first half of 2019
DUBLIN, April 2, 2019 /PRNewswire/ -- Allergan plc, (AGN), a leading global pharmaceutical company and Molecular Partners (MOLN.SW), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® therapies, today announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process. In this single arm study, treatment naïve or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28.
As a result of the improvements in the manufacturing process, the incidence of intraocular inflammation (IOI) was 8.9 percent in the MAPLE study, which was lower than the rate observed in prior Phase 3 studies. Most IOI events were assessed as mild to moderate in severity. The incidence of severe IOI was 1.6 percent with one reported case of iritis and one reported case of uveitis. There were no reported cases of endophthalmitis or retinal vasculitis in this study.
"It is encouraging to see the lower incidence and type of IOI observed in this open label 28-week study," said Raj Maturi, MD, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine. "In the Phase 3 trials previously reported, abicipar demonstrated potential that could transform the way physicians manage nAMD with anti-VEGF therapy. Abicipar could be the first fixed 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients."
"The results of this open-label study enabled us to assess improvements to the manufacturing process for abicipar. The safety profile demonstrated in MAPLE gives us confidence to proceed and scale up manufacturing," said David Nicholson, Chief Research and Development Officer, Allergan. "We plan to submit the abicipar BLA and continue to pursue manufacturing process improvements as we develop larger scale studies in additional disease states, such as Diabetic Macular Edema."
"Clinical trial evidence has shown that fixed-interval dosing of anti-VEGF therapies administered either every month or every 8 weeks results in better visual outcomes compared to real world clinical outcomes. Abicipar could potentially be the first anti-VEGF therapy that is administered every 12 weeks with demonstrated maintenance of visual acuity for a large number of patients with nAMD. A fixed-interval Q12-week therapy would greatly reduce the treatment burden for these patients," said Peter Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Cole Eye Institute.
"Abicipar is our first DARPin® candidate on track for BLA submission with the aim to become the first fixed 12-week anti VEGF drug in all patients with nAMD," commented Michael T. Stumpp, COO of Molecular Partners. He added: "The safety data from the MAPLE trial are an important step in the further improvement of the manufacturing process of abicipar."
Allergan expects to file the abicipar Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2019. Additional data from the MAPLE study will be presented at a scientific conference later in 2019.
About ABICIPAR CEDAR and SEQUOIA PHASE 3 TRIALS
Allergan plc and Molecular Partners previously announced results from two positive Phase 3 clinical trials, CEDAR and SEQUOIA for abicipar, a novel DARPin® therapy for the treatment of nAMD, demonstrating that both the 8-week and 12-week fixed-interval treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab. The primary endpoint measured the proportion of treated patients with stable vision at week 52. In both studies abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study.
In the CEDAR study, overall treatment-emergent adverse events were similar among the three treatment arms and reported in 73.7 percent, 81.1 percent and 73.2 percent of patients receiving abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively. Incidence of intraocular inflammation events was similar among the two abicipar treatment groups but higher than the ranibizumab group and reported at 15.1 percent and 15.4 percent of patients in the abicipar Q8 and Q12 arms compared to 0 percent in the ranibizumab Q4.
In the SEQUOIA study, overall treatment-emergent adverse events were similar among the three treatment arms and reported in 78.3 percent, 78.0 percent and 74.0 percent of patients receiving abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively. Incidence of intraocular inflammation events was similar among the two abicipar treatment groups but higher than the ranibizumab group and reported at 15.7 percent and 15.3 percent of patients in the abicipar Q8 and Q12 arms compared to 0.6 percent in the ranibizumab Q4 arm.
About Allergan plc
Allergan plc (AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotechnology company that is developing a new class of therapies known as DARPin® therapies. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on ophthalmology and oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.
For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.
Contact details Molecular Partners AG
Patrick Amstutz, CEO
Lisa Raffensperger, International Media
Tel: +41 44 755 77 00
Tel: +1 617 903 8783
Thomas Schneckenburger, IR & Media
Susan A. Noonan, IR USA
Tel: +41 44 755 5728
Tel.: +1 212 966 3650
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions.
Manisha Narasimhan, Ph.D.
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