Naegis Pharmaceuticals, Inc. has closed on its latest funding round to support the advancement of its lead investigational compound, N0651, currently in clinical development for the potential treatment of retinal diseases.
Give me the rundown on Naegis.
Naegis Pharma is an ophthalmology-focused biopharmaceutical company developing novel, small-molecule oral and topical therapies for the treatment of serious inflammatory diseases.
The science: The company is targeting two branches of the pathway (LTB4 and cysteinyl [Cys]) that can lead to the production of leukotrienes (LTs), which are central to the inflammatory process that might cause damage to the eye.
Why target these two branches?
Per recent research, LTB4 and CysLTs “drive inflammation in both front-of-the-eye and back-of-the-eye diseases.”
The diseases:
- Macular degeneration
- Diabetic retinopathy (DR)
- Macular edema
- Uveitis
- Conjunctivitis
- Dry eye
By reducing the production of both the LTB4 and CysLT branches, this could lead to blocking the “calling of cells” to the eye, cell leakage, and fluid into the inflamed eye tissue, according to the company.
How are they being blocked?
That’s where Naegis’s investigational candidates come in. This novel class of small molecules have been designed and synthesized to block both LTB4 and CysLT production.
First up: NO651
Tell me about this.
As Naegis’s lead compound, N0651 is a potent inhibitor of LT production.
The candidate is designed to protect the cornea and retina from damage via oral administration.
See here for a visual of its targeted effects.
What kind of clinical data is on it?
While still in the pre-clinical phase, N0651 was reported to demonstrate a “remarkable ability to treat inflammatory diseases, of both the front and back of the eye, when administered either topically or orally.”
- The significance: An eye drop of this type has the potential to “be a game changer” (as the company stated) for serious eye diseases such as macular degeneration and DR.
- Why: Current standard therapies typically require intravitreal administration of growth factor inhibitors or steroid compounds into the back of the eye.
- How: As a non-invasive therapy, the oral administration (or topical formulation) could prove to be both less costly and more comfortable for patients.
Now to this financing.
Per Naegis, the funding will be used over the next 12 months for the advancement of N0651 through to the submission and potential approval of an FDA investigational new drug (IND) application to enter a phase 2 clinical trial.
That’s exciting! What does the company have to say?
Naegis CEO Ian McBeath stated that , as the company’s compounds can block both branches of the leukotriene pathway and are effective by eye drop or oral administration, they offer a real alternative to injections into the eye.”
Lastly, where can I learn more about this?
If you’re attending the Association for Research in Vision and Ophthalmology (ARVO) annual meeting this month (May 5-9, 2024, in Seattle, Washington), you're in luck!
Stop by the Naegis booth in the Exhibit Hall to learn more.