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NEXAGON: About

NEXAGON (LUFEPIRSEN OPHTHALMIC GEL)

First-in-class, patent protected product to redefine the PCED treatment paradigm

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Doctor and Patient

NOVEL
MECHANISM OF ACTION

Proprietary, unmodified antisense oligonucleotide that inhibits the  hemichannel forming protein, connexin43 (Cx43). 

DIFFERENTIATED PRODUCT PROFILE

First-in-class product profile optimized for the treatment PCED, recognized as a potential paradigm shift to current standard of care.

ONGOING
CLINICAL EVALUATION

Amber is currently evaluating the

safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in the clinic for the treatment of PCED.

NEXAGON: Video

NEXAGON blocks connexin43 hemichannel formation, leading to restored corneal healing

Nexagon inhibits hemichannel formation, arresting an exaggerated inflammatory cascade (1,2)

Attenuates cytokine-induced cell death, restoring homeostasis and preserving corneal epithelium (1,2)

Restores limbal stem cell function to promote healing (3)

NOVEL MECHANISM OF ACTION

NEXAGON BLOCKS CX43 HEMICHANNEL FORMATION, RESTORES CORNEAL HEALING

PCED

NEXAGON

Connexin43 Regulation

NLRP3 Inflammasome Activation

Pro-inflammatory Cytokines

Impaired Corneal Healing
Decreased Limbal Stem Cell Fxn

Restores Corneal Healing
Restores Limbal Stem Cell Fxn

ATP

ATP

  • NEXAGON inhibits hemichannel formation, decreasing extracellular ATP messaging, resulting in NLRP3 signal modulation (1,2)

  • Decreased NLRP3 inflammasome activation reduces pro-apoptotic cytokines, cell death, thus promoting healing (1,2)

  • Attenuated NLRP3 inflammasome signaling also restores limbal stem cell function, resulting in healing (3)

NEXAGON: Services

DIFFERENTIATED PRODUCT PROFILE

Nexagon recognized as potential paradigm shift for the treatment of PCED 

ACTIVE MOIETY

Connexin43 antisense oligonucleotide

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DOSING FREQUENCY & DURATION

Dosing regimen optimized for the treatment of PCED

FORMULATION

Thermoreversible Gel

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OCULAR SIDE EFFECTS

Favorable safety profile
demonstrated in multiple human studies

ADMINISTRATION

In-office topical administration

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POTENTIAL INDICATIONS

Rare corneal diseases (PCED, Fuch's), uveitis, keratoconjunctivitis sicca

Nexagon has the potential to be the first approved therapy for the treatment of PCED

NEX-PED-005
(EXPEDE)

A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of Nexagon® (NEXAGON) Applied Topically in Subjects With Corneal Persistent Epithelial Defects Resulting From Severe Ocular Chemical and/or Thermal Injuries 

AMB-01-006
(NEXPEDE-1) 

Actively
Recruiting

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects

ONGOING CLINICAL TRIALS

REFERENCES

  1. Mugisho OO, Green CR, Kho DT, Zhang J, Graham ES, Acosta ML, Rupenthal ID. The inflammasome pathway is amplified and perpetuated in an autocrine manner through connexin43 hemichannel mediated ATP release. Biochim Biophys Acta Gen Subj. 2018;1862(3):385-393.

  2. Campenhout RV, Gomes AR, De Groof TWM, Muyldermans S, Devoogdt N, Vinken M. Mechanisms Underlying Connexin Hemichannel Activation in Disease. Int J Mol Sci. 2021 Mar 28;22(7):3503.

  3. Ormonde S, Chou CY, Goold L, Petsoglou C, Al-Taie R, Sherwin T, McGhee CN, Green CR. Regulation of connexin43 gap junction protein triggers vascular recovery and healing in human ocular persistent epithelial defect wounds. J Membr Biol. 2012;245(7):381-388.

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