Tony Hagen is senior managing editor for The Center for Biosimilars®.
As it emerges from organizational restructuring, Outlook Therapeutics expresses confidence in its bevacizumab candidate for retinal diseases.
Amid the disruption caused by the new coronavirus disease 2019 (COVID-19) a Cranbury, New Jersey, company that is pioneering its own formulation of bevacizumab expects to begin reporting topline data from 2 clinical trials in August of this year.
Outlook Therapeutics, which formerly operated under the name Oncobiologics, provided an update on the development of ONS-5010 (Lytenava) this week in its first-quarter 2020 earnings statement.
The company aims to bring the product to market for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Although reference bevacizumab (Avastin) is used for the treatment of these conditions, ONS-1010 would be the first on-label, or indicated, version of bevacizumab for this purpose, and so the company aims to seek innovator product status via a biologic license application with the FDA through the 351(a) pathway.
Outlook Therapeutics, which is undergoing restructuring to strengthen its financial standing as it pilots this product through the developmental stages, said safety protocols imposed to protect clinicians and patients in ongoing trials for ONS-1010 have affected progress, although the company is on track to report findings as early as late summer 2020.
“Over the course of the last quarter, we made notable progress amidst navigating the uncertainties of the evolving COVID-19 pandemic. Our team remains focused on advancing our ONS-5010 development program as efficiently and rapidly as possible while focusing on the safety, health and welfare of our employees, clinical trial site providers and the patients in our trials,” said Lawrence A. Kenyon, president, CEO, and chief financial officer, in a statement.
With wet AMD, abnormally high levels of vascular endothelial growth factor (VEGF) accumulate in the eye. VEGF promotes the growth of abnormal blood vessels, and bevacizumab is an anti-VEGF recombinant monoclonal antibody that inhibits VEGF and associated blood vessel development activity. It has become a standard-of-care treatment option around the globe, according to Outlook.
Bevacizumab is already widely used for the treatment of wet AMD and, in fact, has been shown to be highly cost-effective in comparison with other anti-VEGF treatments, such as aflibercept and ranibizumab. The agent is administered via injection into the vitreous fluid at the back of the eye. Avastin, the original bevacizumab, is not indicated for treatment of wet AMD although it is commonly used for that purpose.
Enrollment was completed in August 2019 for NORSE 1, a safety and efficacy trial (N = 61) for the bevacizumab candidate, and it is this trial for which the company expects to report findings during the third calendar quarter of 2020. NORSE 1 is comparing ONS-5010 with ranibizumab. No adverse effects from the COVID-19 pandemic are expected to delay progress with this trial, the company said.
NORSE 2 is enrolling 220 patients at 40 clinical sites in the United States. This trial began in July 2019, and the primary outcome is a statistically significant improvement in visual acuity. The comparator drug is also ranibizumab. August 2020 is also the anticipated date for completion of enrollment. The company said it is not expecting COVID-19 to affect enrollment.
Contingent upon marketing approval in the United States, the product would be sold in vials and single-use prefilled syringes. Outlook also plans to commercialize the product in France, the United Kingdom, Italy, Germany, Spain, and Japan.
In other developments, the company has entered a partnership with BioLexis of Singapore, its largest shareholder and its development partner for ONS-5010, to help with the financial streamlining and ensure the partners retain 100% of any future net profits for ONS-5010.