Outlook Therapeutics Receives FDA Agreement Under SPA for 90 Day Noninferiority Study, NORSE EIGHT
Outlook Therapeutics announced that it has received written agreement from the FDA under a special protocol assessment (SPA) for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in wet age-related macular degeneration (AMD) subjects. Additionally, Outlook Therapeutics announced it entered into securities purchase agreements with institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.
“The SPA increases our confidence that ONS-5010, if approved, will more effectively meet the needs of retina surgeons, patients and payers in the $9.5 billion ophthalmic anti-VEGF market in the United States, and the financing represents a significant commitment by our new and existing stockholders to advance this important development program,” Russell Trenary, President and Chief Executive Officer, said in a company news release. “We believe that the funds we expect to receive in this financing will position Outlook Therapeutics to support the ONS-5010 development pathway through potential FDA approval and launch.”
According to Outlook, the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the complete response letter (CRL).
NORSE EIGHT will be a randomized, controlled, parallel-group, masked, noninferiority study of approximately 400 newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint will be mean change in BCVA from baseline to week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024. In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the chemistry, manufacturing and controls comments in the CRL. Outlook Therapeutics is working to address the open items and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
Additionally, Outlook Therapeutics announced that it has entered into a definitive securities purchase agreement with certain institutional and accredited investors to purchase shares of common stock and accompanying warrants in a private placement, the closing of which is conditioned upon stockholder approval of the transaction and certain other corporate actions, expected in the first quarter of 2024. The private placement is expected to provide up to $60 million in gross proceeds at closing, before deducting placement agent fees and offering expenses. In addition, Outlook Therapeutics will have the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants being issued in the private placement, before deducting placement agent fees and offering expenses. The warrants include a feature that allows Outlook Therapeutics to require cash exercise if certain stock price and milestone conditions are met.
Outlook Therapeutics also entered into a securities purchase agreement with Syntone Ventures, another existing stockholder, to purchase $5 million in shares of common stock and warrants on the same terms as the private placement, subject to receipt of requisite approvals in addition to the necessary corporate action items described above.
Outlook Therapeutics intends to use the net proceeds from the financings to fund its ONS-5010 clinical development programs, including to initiate and fund the planned NORSE EIGHT clinical trial, and for working capital and other general corporate purposes.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases.