Minimally Invasive treatment with ExoPTEN showed functional restoration of damaged eyes to healthy levels in animals
TORONTO and HAIFA, Israel, July 17, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, is pleased to announce the preliminary results from a small-scale controlled study exploring the use of its flagship nanodrug, ExoPTEN, for optic nerve recovery in a rat model at Sheba Medical Center. This study marks a second clinical indication being investigated for ExoPTEN.
The study was initiated by Professor Michael Belkin, following the success of ExoPTEN in nerve regeneration in the spinal cord indication in preclinical models. An Optic Nerve Crush (“ONC”) model was used to simulate conditions like glaucoma, where the optic nerve is crushed, resulting in impaired vision.
Glaucoma is a common eye condition, particularly in older adults typically caused by optic nerve compression and pressure in the eye. The prevalence of glaucoma in the Western world is generally estimated to be around 2-3% in people aged 40 and older. The risk increases with age, and the prevalence can be higher in populations over 60. Estimated Number of People Affected in the United States alone, is over 3 million people, with many more cases likely undiagnosed.
The study carried out under Prof. Ygal Rotenstreich and Dr. Ifat Sher of Sheba Medical Center explored the therapeutic effects of ExoPTEN on retinal function after ONC compared to healthy baseline levels, an untreated ONC control and ONC treated with na?ve exosomes. Importantly ExoPTEN was administered minimally-invasively using suprachoroidal injection in a delivery system invented by Prof. Rotenstreich.
As expected, the post-ONC control eyes exhibited a marked decline in retinal functionality, as evidenced by the lack of a peak (Fig. A – red graph). Experimental treatments with ExoPTEN (“ONC+PTEN"), showed promising results, with treated eyes exhibiting a peak similar to the healthy eye in the same animal indicating recovery of retinal response following optical nerve compression (Fig. B – green graph). The na?ve exosome-treated rats (“ONC+EXO”) showed a lower peak and increased latency indicating a weaker response (Fig. C – brown graph). The results presented are from just 18 days following the ONC damage. These treatment findings suggest potential pathways for recovery of optic nerve function and overall healthy vision.
Dr. Ifat Sher and Prof Ygal Rotenstreich of Sheba Medical Center commented: "While these results are preliminary, they form a solid foundation for further research. Our next steps include more extensive studies to validate these findings and explore their potential application for humans."
Dr. Lior Shaltiel, CEO of NurExone, added: "We are excited by these preliminary findings and commend the team at Sheba for this work, which is an important step in our mission to develop regenerative therapies. These early studies suggest potential for ExoPTEN in the US$3.4 billion glaucoma market and will allow us to help those affected by retinal degenerative conditions."
Electroretinogram (ERG) measurements
Figure 1 – Positive impact of specific treatments on retinal health
Graphs A-C show Electroretinogram (ERG) measurements of dark-adapted (scotopic) threshold retinal response (STR, in microvolts, ?V) at -36 dB of three representative rats. In each rat, one eye was left intact as a healthy control (“Healthy”, gray). Rat A had ONC in one eye (red) with no treatment, which resulted in a flat, near-zero retinal response. Rat B had ONC in one eye and was treated with ExoPTEN (green, ONC+PTEN), resulting in a retinal response similar to the healthy intact contralateral eye. Rat C had ONC in one eye and was treated with na?ve exosomes (brown, ONC+EXO), resulting in a recordable but delayed and smaller retinal response compared to the healthy control contralateral eye. The results are following the minimally-invasive administration of two treatment cycles (one post-operation and the other in the subsequent week), with a volume of 20μL per eye in the treated and the control rats (na?ve exosomes).
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV listed pharmaceutical Company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Dr. Lior Shaltiel Chief Executive Officer and Director Phone: +972-52-4803034 Email: [email protected]
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