Oct 29 2018
Zurich-Schlieren, SWITZERLAND—Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that the phase 3 safety and efficacy data of abicipar in patients with neovascular Age-related Macular Degeneration (nAMD) were presented at the American Academy of Ophthalmology (AAO) conference in Chicago.
In two global phase 3 studies, called SEQUOIA and CEDAR, a total of more than 1,800 patients with nAMD were treated with a fixed treatment regimen of either 2 mg abicipar every 12 weeks (2q12) or every 8 weeks (2q8) following three loading doses, or the comparator, monthly ranibizumab (Lucentis®).
The data show that both abicipar regimens met the pre-specified criteria for non-inferiority to monthly ranibizumab for the primary endpoint (defined as stable vision at week 52) in both SEQUOIA and CEDAR. Additionally, the initial vision gains for abicipar fixed 2q12 and fixed 2q8 were maintained throughout week 52.
The anatomical data (OCT) on abicipar-treated patients showed reductions of central retinal thickness (CRT) in all arms in both studies in the same range as for ranibizumab. Overall, the efficacy endpoints at week 52 showed comparable efficacy with 6-8 injections of abicipar vs. 13 injections of ranibizumab.
The overall incidence of treatment emergent adverse events was comparable among all three treatment groups. Abicipar-treated patients had a higher risk of developing intraocular inflammation (IOI) compared to ranibizumab-treated patients. The majority of IOI were mild to moderate and were treated with topical corticosteroids.
“The data presented at AAO represent another significant milestone for Molecular Partners, as our first DARPin® candidate has generated positive Phase 3 data,” commented Dr. Patrick Amstutz, Chief Executive Officer of Molecular Partners.
“We are very impressed by the vision and anatomical data presented,” added Dr. Michael Stumpp, Chief Operating Officer of the company. “These data underline that abicipar has the potential to become the first fixed 12-week anti-VEGF therapeutic.”
Allergan plans to file abicipar with the FDA in H1 2019 pending a pre-BLA (biologics license application) meeting with the FDA. Additionally, Allergan expects to share results from the MAPLE trial, using a further optimized formulation of abicipar, in H1 2019.
November 1, 2018 Q3 2018 Management Statement
December 6, 2018 R&D Day in New York
February 7, 2019 Publication of Full-year Results 2018 (unaudited)
March 15, 2019 Expected Publication of Annual Report 2018
April 16, 2019 Annual General Meeting
About the DARPin® Difference
DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin® drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapeutics. With a management team that includes many of the founding scientists, 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 oncology and immuno-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.
For further details, please contact:
Patrick Amstutz, CEO Lisa Raffensperger, International Media
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.