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Details:
NCX 470 (OT-301) is a novel nitric oxide-donating prostaglandin analog used for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
OT-301 (NCX 470) is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin analog eye drop designed to release bimatoprost and NO following instillation into the eye.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2022
Details:
In the earlier Dolomites Phase 2 clinical trial of NCX 470, demonstrated 0.065% statistical superior lowering of intraocular pressure of up to 1.4 mmHg compared to latanoprost 0.005% at Day 28.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
Topline results on the Dolomites, NCX 470, 0.065% achieved statistical superiority compared to latanoprost 0.005% at all timematched points measured on day 28, with a peak improvement in intraocular pressure lowering of 1.4 mmHg greater than latanoprost.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2022
Details:
NCX 470, Nicox’s lead product candidate, is a novel nitric oxide (NO)-donating prostaglandin analog designed to release bimatoprost and NO into the eye. NCX 470 is designed to release both bimatoprost and NO following instillation into the eye.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2022
Details:
The proceeds of the private placement will be fully allocated to NCX 470. The Company intends to use the proceeds of the private placement, by order of priority, to complete the Mont Blanc trial (approximately 40%), continue to progress the Denali trial.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kreos Capital
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 09, 2021
Details:
NCX 470, a novel nitric oxide-donating bimatoprost in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
The objective with these two trials is to demonstrate statistically superior efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed PGA in the U.S., for the lowering of IOP.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
50% of patients in the Mont Blanc NCX 470 Phase 3 glaucoma clinical trial have now been randomized out of a target of 670, with top-line results currently on track to be announced during Q2 2022.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
Nicox’s lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2021
Details:
The Company was previously financed to complete both the Mont Blanc Phase 3 trial for NCX 470 and the Mississippi Phase 2b trial for NCX 4251. Proceeds from this financing extend the cash runway well beyond these key inflection points.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: HBM Healthcare Investments
Deal Size: $18.1 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 04, 2020
Details:
Denali is a 3-month Phase 3 trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: OcuMension Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
Nicox and Ocumension will jointly fund the second NCX 470 Phase 3 glaucoma trial, Denali, which is expected to start by end of 2020 and will also evaluate NCX 470 ophthalmic solution, 0.1%, versus latanoprost ophthalmic solution, 0.005%.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: OT-301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nicox SA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Nicox completed enrollment of adaptive design patient cohort in its multicenter Mont Blanc Phase 3 trial, evaluating NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution, 0.005% for the lowering intraocular pressure in open-angle glaucoma or ocular hypertension.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Over 40 sites have been initiated in the first month of the Phase 3 Mont Blanc trial, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
The divestment will support Nicox's strategy for rapid advancement of their R&D pipeline and NDA submissions for their two lead product candidates, NCX 470 and NCX 4251.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: NCX 470
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GHO Capital
Deal Size: $5.7 million Upfront Cash: Undisclosed
Deal Type: Divestment July 10, 2020
Details:
The Mont Blanc trial is a multi-regional, double-masked, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Details:
Nicox will conduct both of its planned Phase 3 clinical trials, Mont Blanc and Denali, as multi-regional clinical trials in U.S. and China.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ocumension Therapeutics
Deal Size: Undisclosed Upfront Cash: $3.3 million
Deal Type: Licensing Agreement March 11, 2020
Details:
NCX 470 demonstrated both statistical non-inferiority and superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 05, 2020
Details:
NCX 470 is covered by a composition of matter patent until 2029, which is potentially eligible for up to a 5-year patent term extension based on the period of regulatory review.
Lead Product(s): NCX 470
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 February 03, 2020
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