TheiaNova Ltd. announced the first patient dosing in a proof-of-concept (POC, first-in-human (FIH) trial evaluating its investigational eye drop for the treatment of keratoconus.
Nothing like a new study to kick off the new year … but refresh me on TheiaNova.
Based in Auckland, New Zealand, TheiaNova is a spin-out early-stage company of the University of Auckland (see here for more on its origins)—with investment backing from a few key partnerships.
Its scientific focus involves reprogramming keratocytes (corneal cells) to produce a form of collagen typically only expressed in the embryonic development stage.
Specifically: These reprogrammed cells could be used to strengthen (rebuild) the corneas of keratoconus patients in order to prevent additional damage (such as corneal distortion and visual deterioration).
And how would this be possible?
Via the development of a noninvasive treatment—formulated as an eye drop—that induces corneal remodeling in patients with ectatic disorders (keratoconus).
Its name: TN-001.
So what do we know about this patented therapeutic?
Based on our prior coverage:
Its formulation: Is a combination of human growth factor beta-3 (TGF-B3) and dexamethasone sodium phosphate (already FDA-approved for ocular use) to trigger developmental pathways
- It’s intended as a twice-daily dose topically applied over a 3-week duration
- Its purpose is to regenerate lost collagen in the eye (restoring the cornea’s rigidity)
And how has the drop performed thus far?
Harkening back to the scientific research the company’s founding is based on, cell cultures and animal trials have found TN-001 can regenerate collagen and restore corneal rigidity.
Now to the trial.
Currently being conducted at a single clinical site in Australia, the POC trial is evaluating the safety and ocular tolerability of TN-001 eye drops when topically administered to adult keratoconus patients.
- Importantly: The company emphasized that the study is “not designed or powered to demonstrate definitive clinical efficacy.”
At the time of this reporting: No further details on the study setup, participant information, outcome measures, or an estimated end date were readily available.
- For additional information, reach out to TheaiNova directly (info@theianova.com).
And what’s the expectation?
TheiaNova intends for the study to generate data that will guide dose selection of TN-001, as well as a future clinical study design (if you recall from our prior reporting, the company is looking to conduct both phase 1 and 2 studies on the eye drop).
“This milestone marks our transition into patient-based clinical development and reflects the completion of years of preclinical and formulation groundwork,” CEO Carissa Fonseca noted.
Go on …
Pending the potential success of this trial, the company is looking to pursue regulatory clearance for TN-001. And to do this, TheiaNova will need new investments.
In recent coverage on the company from Bridgewest Ventures (a current investment partner) TheiaNova co-founder Colin Green, PhD, shared his pitch for potential investors:
- “The treatment has been shown to work in human tissues and has potential to translate readily and safely to the clinic. With TheiaNova’s [pending future] completion of a human POC trial, risk will be wrung from an attractive investment … which for keratoconus alone provides a significant market opportunity.”