Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Mont Blanc Phase 3 Trial

 

October 26, 2020 – release at 7:30 am
Sophia Antipolis, France

 

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out the Chinese part of the ongoing Mont Blanc trial, the first Phase 3 clinical trial on NCX 470 for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

 

NCX 470, Nicox’s lead clinical product candidate, is a novel second generation nitric oxide (NO)-donating bimatoprost analog exclusively licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.

 

Dr. José Boyer, VP and Interim Head of R&D at Nicox, said: “We are pleased with this second Chinese IND approval in our collaboration with Ocumension.  NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021.  Initiation of Chinese sites in this trial will be essential in preparing the way for Denali, the second Phase 3 trial with NCX 470, which will include a larger number of Chinese patients.”

 

The Press Release by Ocumension can be found here:

The NCX 470 Mont Blanc Phase 3 clinical trial is a 3-month trial to evaluate 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.  The Mont Blanc trial is expected to randomize approximately 670 patients, at around 50 clinical sites in the U.S. and at a small number of clinical sites in China.  The Mont Blanc trial was initiated in the U.S. in June 2020 and top-line results are currently expected in Q4 2021. 

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%.  The Denali trial will include clinical sites in both the U.S. and China, with the large majority of the patients to be recruited in the U.S.  The Denali trial was designed to fulfill the regulatory requirements to support New Drug Application (NDA) filings in the U.S. and China.

 

NCX 470 is a novel, potential best-in-class, second generation nitric oxide (NO)-donating bimatoprost analog in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual field loss and it can eventually lead to blindness if not treated. It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or malfunction of the eye’s aqueous humor drainage system in the front of the eye.  In 2019, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $21.9 billion worldwide market for ophthalmic drugs. 

NCX 470 is designed

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Mont. pursues action over mask use noncompliance

HELENA, Mont. — Montana Gov. Steve Bullock says the state health department is pursuing legal action against several businesses in northwestern Montana for not following a mask mandate and other restrictions meant to prevent the spread of the coronavirus.

The announcement came Thursday as the state reported 932 newly confirmed coronavirus cases. That was far above the previous one-day high of 734.

The new cases include 173 in Yellowstone County and 112 in Flathead County, where the governor says businesses face legal action.

State officials also have launched a new website to allow people to submit complaints against businesses and events that are not complying with health directives.


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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— France extends curfew to 38 regions because of coronavirus surge

— African health officials expect WHO distribution of rapid virus tests

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— Britain offering financial help for bars, pubs and restaurants struggling because of restrictions due to the coronavirus.

— Czech Republic enters second lockdown to avoid health system collapse. New measures include closing stores, shopping malls and hotels.

— Photographer in Dubai providing free photo shoots to laid-off expats forced to leave the skyscraper-studded Persian Gulf city because of the pandemic.

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Follow all of AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

ROSWELL, N.M. — Officials at a military junior college in New Mexico say the school is under quarantine after more than 60 cadets and employees tested positive for the coronavirus. Those who tested positive are being kept isolated.

The quarantine at the New Mexico Military Institute is expected to last until Oct. 29. Parents will be allowed to visit only in special situations or emergencies, and officials say all campus facilities are being closed to the public for five weeks.

The closure comes as the state struggles with a surge in coronavirus infections. Wednesday marked another record day for daily confirmed cases, with 827, and state health officials reported an additional 669 cases Thursday. That brings the statewide total to nearly 39,380 since the pandemic began.

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BATON ROUGE, La. — Louisiana will allow more high school football fans to attend games in open-air stadiums beginning Friday if the events are in parishes with low numbers of coronavirus cases in the last few weeks.

Gov. John Bel Edwards said Thursday that stadiums will be allowed to have crowds at 50% capacity in parishes where 5% or less of coronavirus tests have come back positive in the previous two weeks. Stadiums have been capped at 25% capacity.

The governor says 26 of Louisiana’s 64 parishes meet the criteria to boost crowd size.

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MONTGOMERY, Ala. — Alabama Lt. Gov. Will Ainsworth said Thursday that he remains opposed to mandatory mask orders despite being diagnosed with COVID-19, even though he encourages people to wear one.

The Republican lieutenant governor announced Wednesday that he tested positive for the coronavirus. He said he sought a test

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