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Clene Inc. (NASDAQ: CLNN) Capitalizing on the Promising Chemical and Therapeutic Properties of Nanocrystals to Address High Unmet Medical Needs

  • Clene is focused on developing and commercializing novel clean-surfaced nanotechnology (“CSN(R)”) therapeutics
  • The company utilizes an electro-crystallization nanotherapeutics platform, which results in nanocrystals that exhibit catalytic activities multiple times higher than numerous other commercially available nanoparticles that the company has comparatively evaluated
  • Clene is focusing on central nervous system (“CNS”) disorders like amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”)
  • Its lead investigational product, CNM-Au8(R), has so far demonstrated a good safety and tolerability profile, with Phase 2 trials suggesting efficacy in ALS patients

Nanotechnology has attracted a great deal of the scientific community’s attention thanks to its ability to deliver medicinally attractive nanoparticles (“NPs”) with promising performances that are directly attributable to such properties as ease of cellular uptake, stability, solubility, synthetic accessibility, and release pattern and cell penetration.

Studies investigating the therapeutic capabilities of metallic NPs such as selenium, silver, and gold, as well as metallic oxides like zinc oxide and aluminum oxide, have documented their potential anti-diabetic, antibacterial, antiviral, and antiparasitic capabilities (https://nnw.fm/6nofg). Moreover, metallic nanoparticles have been known to have remarkable catalytic activity due to their large surface-area-to-volume ratio compared to the bulk material. This property has led to the development of therapeutic candidates, with Clene (NASDAQ: CLNN), a clinical-stage pharmaceutical company, leading the way.

Clene’s efforts date back to 2013 when the company innovated an electro-crystallization nanotherapeutics platform. The innovation led to the development of novel clean-surfaced nanotechnology (“CSN(R)”) therapeutics that, the company explains (https://nnw.fm/cPqQD), “are comprised of atoms of transition elements that, when assembled in nanocrystal form, possess unusually high, unique catalytic activities not present in those same elements in bulk form.” In fact, Clene underlines that its platform results in nanocrystals that exhibit catalytic activities multiple times higher than numerous other commercially available nanoparticles that the company has comparatively evaluated.

The catalytic activities, the company notes, drive, support, and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed, and damaged cells and have influenced the development of multiple drug candidates, including its lead investigational product, CNM-Au8. The company is currently focusing its efforts on addressing the high unmet medical needs related to CNS disorders like ALS, MS, and PD, conditions that cumulatively affect more than 1.4 million people in the U.S.

CNM-Au8 is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals that has been the subject of multiple non-clinical studies and clinical trials. Non-clinical toxicology studies, for instance, have demonstrated no adverse effect levels, even when the maximum feasible dosing levels were orally administered. Moreover, in vitro and in vivo pharmacology studies have demonstrated that CNM-Au8 treatment improves neuroprotection and generation of new myelin sheaths around axons of the adult CNS in multiple models of ALS, MS, and PD.

“A Phase I first-in-human study did not reveal safety or tolerability concerns for CNM-Au8 in healthy human volunteers. Similarly, no significant safety signals have been identified across all completed Phase 2 clinical trials in ALS, MS, and PD populations. Two Phase 2 clinical trials in ALS (RESCUE-ALS and the HEALEY ALS Platform Trial) suggested efficacy signals without any significant safety findings,” wrote the company in its 2022 annual report (https://nnw.fm/K3rCK).

This September, Clene released long-term follow-up data for patients treated with CNM-Au8 for up to 133 weeks in the open-label extension (“OLE”) of the HEALEY ALS Platform Trial. These results showed significantly improved survival compared to matched placebo controls obtained from the Pooled Resource Open-Access ALS Clinical Trials (“PRO-ACT”) database, the largest U.S. clinical database of previous ALS trials. The follow-up analysis also pooled data from both the HEALEY ALS Platform Trial and the RESCUE-ALS trial, revealing that patients originally randomized to the CNM-Au8 30mg dose demonstrated a statistically significant 59% decreased risk of death compared to matched placebo patients.

“To show such profound survival improvement using the HEALEY ALS Platform Trial dataset alone and a pooled HEALEY and RESCUE dataset is remarkable, and helps confirm the survival benefit seen in the prespecified secondary endpoint. Clene is extremely gratified to see this consistent long-term survival data from the HEALEY ALS Platform Trial OLE, with a continued clean safety profile, adding to the totality of survival evidence,” Benjamin Greenberg, M.D., Head of Medical at Clene, stated in the press release announcing the results of the follow-up analysis (https://nnw.fm/u307C).

Clene is the sole inventor of its CNS therapeutic drug candidates, as well as the candidates’ manufacturing processes and methods of use. These inventions are protected by a comprehensive intellectual property portfolio of over 150 patents issued worldwide, with about 20 additional patents pending, as of December 31, 2022. The IP portfolio provides a solid foundation for the company‘s planned commercialization of its CSN therapeutics subject to U.S. Food and Drug Administration (“FDA”) approval.

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN

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