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Details:

APX3330 is a first-in-class, small molecule, oral inhibitor of transcription factor regulator Ref-1, including those involving angiogenesis (VEGF) and inflammation (NFkB) to decrease their abnormal activation that are implicated across several ocular diseases.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2023

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APX3330, a novel, first-in-class, twice-daily oral tablet drug candidate, specifically targets Apurinic/Apyrimidinic Endonuclease 1/Redox Effector Factor-1 (APE1/Ref-1) protein, referred to as Ref-1.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 24, 2022

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Details:

APX3330 has shown a favorable safety and tolerability profile over 11 clinical trials conducted in healthy, hepatitis, and cancer subjects prior to the current Phase 2 ZETA-1 trial in diabetic retinopathy.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 08, 2022

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Details:

APX3330 is a small molecule oral drug candidate and a first-in-class inhibitor of the transcription factor regulator Ref-1 (reduction-oxidation effector factor-1).


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2022

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Details:

The results showed a favorable ophthalmic and systemic safety and tolerability profile, consistent with 11 prior safety trials of APX3330 in non-ophthalmic indications, for the treatment of diabetic retinopathy.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2022

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Details:

APX3330 is a potential first oral therapy for DR/DME, has a highly differentiated dual mechanism of action supported by an extensive body of evidence suggesting that targeting Ref-1 can block both angiogenesis and inflammation.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2022

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Details:

Ocuphire’s candidate, APX3330, is a first-in-class oral Ref-1 inhibitor with a novel dual anti-VEGF for the treatment of diabetic retinal diseases and Nyxol (0.75% phentolamine ophthalmic solution), is a non-selective alpha-1 and 2 adrenergic inhibitor.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 31, 2022

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Details:

In five Phase 2 studies involving over 300 patients, APX3330 given oral (systemically) was well tolerated with no significant safety issues identified. No AE was observed in ≥ 5% of patients treated with APX3330.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 22, 2021

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Details:

APX3330 is a small molecule oral drug candidate and a first-in-class inhibitor of the transcription factor regulator Ref-1 (reduction-oxidation effector factor-1).


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: APX3330

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 08, 2021

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Details:

Under the terms and conditions of the deal, Ocuphire earns an exclusive worldwide sublicense to Apexian’s Ref-1 Inhibitor program, including its lead drug candidate APX3330.


Lead Product(s): APX3330

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Ocuphire Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 22, 2020

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