NurExone Demonstrates Extended Therapeutic Window of ExoPTEN Post Spinal-Cord Injury in Preclinical Study

Rhea-AI Summary

NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) has announced promising results from a preclinical study of ExoPTEN for spinal cord injuries. The study demonstrated that ExoPTEN can effectively target and accumulate at injury sites up to one week after the injury occurred, potentially broadening the range of treatable patients and extending the window for effective treatment.

Key findings include:

• ExoPTEN showed strong homing capacity to injury sites even 7 days post-injury
• Later administration times resulted in higher levels of accumulation
• The highest accumulation was observed in subjects treated 7 days post-injury
• Results suggest a broad therapeutic window for intervention

These findings could significantly impact clinical trial design and patient care, offering hope for more flexible treatment regimens in spinal cord injury cases.

Positive

• ExoPTEN demonstrated effective targeting and accumulation at spinal cord injury sites up to 7 days post-injury
• Extended therapeutic window could potentially broaden the range of treatable patients
• Later administration times resulted in higher levels of ExoPTEN accumulation at injury sites
• Findings may enhance patient recruitment for clinical trials
• Results suggest potential for adaptable treatment regimens in clinical settings

Negative

• None.

TORONTO and HAIFA, Israel, Sept. 06, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”) is pleased to announce compelling new findings that highlight the therapeutic potential of ExoPTEN for patients with spinal cord injuries. In a recent preclinical study using a spinal cord compression model, our team demonstrated that ExoPTEN has a strong ability to target and accumulate at the injury site, even when administered up to one week after the injury occurred. This finding is crucial because it suggests a long window of time in which treatment can be effectively administered.

Dr. Lior Shaltiel, NurExone Chief Executive Officer, emphasized the real-world significance of this capability by stating that “the ability to treat patients up to 7 days post-injury could broaden the range of patients eligible for treatment and extend the window of effectiveness, leading to enhanced recovery. Moreover, the findings can enhance significantly the ability to recruit more patients to clinical trials and to expand the numbers of treatable patients, without being limited by a short therapeutic window and hospital administration challenges." He continued, "With the global incidence of spinal cord injury estimated between 250,000 and 500,000ⁱ cases annually and given that some patients do not receive immediate treatment, the potential market for a therapy effective up to 1-week post-injury could be substantial."

As shown in Figure 1, the ExoPTEN was labelled with a fluorescent mark and administered to rats with induced spinal cord compression injuries. The administration was conducted at four different time points: on the day of injury (day 0), 3 days later, 5 days later, and 7 days later, and compared to each other and to an untreated control group. The goal was to evaluate how well ExoPTEN targets and accumulates at an injury site over time.

Using an advanced In Vivo Imaging System (“IVIS”), it was observed that ExoPTEN consistently accumulated at the injury site. A notable gradient of homing capacity was observed, with later administration times resulting in progressively higher levels of accumulation. The highest accumulation was seen in those treated 7 days post-injury with a statistically significant dose-dependent accumulation of ExoPTEN at the injury site.

These results underscore the exceptional homing capacity of ExoPTEN, even 7 days post-injury, suggesting a broad therapeutic window for intervention. This creates new possibilities for the timing and flexibility of treatment, enhancing the potential for recovery in patients with spinal cord injuries.

Dr. Noa Avni, Director of research and development stated that “we are excited about the implications of these findings for our phase I/II clinical trial design and patient care. The extended therapeutic window we have demonstrated not only highlights the potency of our exosome-based therapy but also offers hope for adaptable treatment regimens in clinical settings."

Figure 1: Quantification and Distribution of ExoPTEN in Rat Spinal Cords Following Minimal-Invasive Administration Post-Spinal Cord Injury

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”) and OTCQB 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.

For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Thesis Capital Inc.
Investor Relations - Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com

Dr. Eva Reuter
Investor Relations - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

Allele Capital Partners
Investor Relations - US
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to the results and implications of the study; the timeframe for the administration of treatment and the potential eligibility of patients; the treatment leading to enhanced recovery; there being a broad therapeutic window for intervention; there being adaptable treatment regimens in clinical settings; the Company’s ExoPTEN nanodrug being a potential treatment for acute spinal cord injuries and other central nerve system indications; the Company engaging with collaboration partners, industry leaders, researchers and innovators; and the NurExone platform technology offering novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; partnerships having their intended impact on the Company and its business; patents safeguarding NurExone’s technology; the Company’s drug products having its intended benefits and effects; the Company making progress through new partnerships and technologies to move towards commercialization of their products; the Company’s intellectual property and technology being novel and inventive; the intellectual property having the intended impact on the Company and its business; exosomes becoming an ideal and natural choice for drug delivery; the Company making advancements in the manufacturing process of exosomes; exosomes holding immense promise for regenerative medicine; the Company’s production methods continuing to be reliable; the Company will have flexibility in optimizing its exosome production method; exosomes will serve as an excellent, targeted system for drug delivery; the Company will pave the way to regenerative medicine treatments for a variety of clinical indications by the Company and with future collaboration partners; the Company’s ExoPTEN nanodrug being a potential treatment for acute spinal cord injuries and other central nerve system indications; the Company will engage with collaboration partners, industry leaders, researchers and innovators; the study will yield its intended results and have its intended implications on the Company and its business; ExoPTEN will have a longer timeframe for the administration of treatment and therefore there will be additional eligible patients; the treatment will lead to enhanced recovery; there will be a broad therapeutic window for intervention; there will be an adaptable treatment regimens in clinical settings; and the NurExone platform technology offering novel solutions to drug companies.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; protection of the Company’s intellectual property; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the NurExone platform technology being unable to offer novel solutions to drug companies; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to realize upon partnerships; risk that the exosomes will not become an ideal and/or natural choice for drug delivery; risk that the company will be unable to make advancements in the manufacturing process of exosomes; risk that exosomes will not be a viable option in regenerative medicine; risk that the Company’s production methods will become unreliable; risk that the Company will not have flexibility in optimizing its exosome production method; risk that exosomes will not serve as a targeted system for drug delivery; risk that the Company will be unable to pave the way to regenerative medicine treatments for a variety of clinical indications by the Company and/or with future collaboration partners; risk that the Company’s ExoPTEN nanodrug will not work as a potential treatment for acute spinal cord injuries and/or other central nerve system indications; risk that the Company will be unable to engage with collaboration partners, industry leaders, researchers and/or innovators at the conferences or at all; risk that the NurExone platform technology will be unable to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications; risk that the study will not yield its intended results and/or have its intended implications on the Company and its business; risk that the timeframe for the administration of treatment will not be longer and/or will not lead to more eligible patients; risk that the treatment will not lead to enhanced recovery; risk that there will not be a broader therapeutic window for intervention; risk that there will not be adaptable treatment regimens in clinical settings; and the risks discussed under the heading “Risk Factors” on pages 29 to 36 of the Company’s Annual Information Form dated March 30, 2023, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

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ⁱhttps://iris.who.int/bitstream/handle/10665/94190/9789241564663_eng.pdf?sequence=1

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6349d08a-be42-434d-9a78-e2158d074d9b

FAQ

What is the main finding of NurExone's preclinical study on ExoPTEN (NRXBF)?

The main finding is that ExoPTEN can effectively target and accumulate at spinal cord injury sites up to one week after the injury occurred, demonstrating an extended therapeutic window for potential treatment.

How might the extended therapeutic window of ExoPTEN (NRXBF) impact patient treatment?

The extended therapeutic window could broaden the range of patients eligible for treatment, enhance recovery potential, and allow for more flexible treatment regimens in clinical settings for spinal cord injury patients.

What was observed regarding ExoPTEN accumulation in the NurExone (NRXBF) preclinical study?

The study observed a gradient of homing capacity, with later administration times resulting in progressively higher levels of ExoPTEN accumulation at the injury site, with the highest accumulation seen in subjects treated 7 days post-injury.

How could NurExone's (NRXBF) findings on ExoPTEN affect clinical trials?

The findings could significantly impact clinical trial design by enhancing patient recruitment, allowing for a broader range of participants, and potentially leading to more flexible treatment protocols in spinal cord injury studies.