Outlook Therapeutics Inc (OTLK)

[H2R]

TLD (open-label) NORSE THREE on target for Q2 2021

This is the kind of news I do like to see from a biotech company planning to submit a BLA in Q4/2021. It means the pieces of the puzzle are falling into place and the planned timeline looks good.

This PR is about Norse 3, but you can see how it all plays in their building the case for the BLA submission.

I hope the Company keeps PR'ing these types of milestone. Very encouraged.

MONMOUTH JUNCTION, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE)

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a?late clinical-stage?biopharmaceutical company?working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that the last patient completed their final visit for the ongoing open-label safety study evaluating ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat retinal diseases (NORSE THREE).

Two of the three planned clinical trials for the ONS-5010 / LYTENAVA™ wet age-related macular degeneration (wet AMD) U.S. Biologics License Application (BLA) are now completed. The open-label safety study enrolled 197 subjects, in only 4 weeks, with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal (IVT) doses of ONS-5010 / LYTENAVA™. The data from this study is expected to be reported in the second quarter of calendar 2021 and will be included in the complete data package to support the planned BLA for wet AMD, on schedule for submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of calendar 2021.

“We sincerely thank the clinicians and study participants for their commitment and dedication to completing this safety study in this ongoing pandemic environment. The NORSE THREE study plays a key role in our overall ONS-5010 registration program. With the last patient visit now completed in this study, we are focused on the successful completion and data readout for the pivotal NORSE TWO Phase 3 study of ONS-5010 for the treatment of wet AMD, followed by our planned BLA submission,” added Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics.

Following the data readout from both the open-label safety study and the pivotal safety and efficacy study, Outlook Therapeutics plans to submit a new BLA filing to the FDA under the PHSA 351(a) regulatory pathway. If the BLA is approved, it will result in 12 years of marketing exclusivity for ONS-5010.

Commercial launch planning has begun, including distribution, physician and patient outreach, key opinion leader support and payor community engagement. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010, if approved, to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retinal indications.

In addition to the clinical development plan evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat BRVO (NORSE FOUR), and two planned registration clinical trials evaluating ONS-5010 for the treatment of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.

Best of luck with your investments!