Nicox

“We expect 2025 to be an inflection point for the company.” Gavin Spencer, CEO of Nicox. 2024 has been a very productive year for Nicox where we have stabilized the financial situation whilst continuing the clinical development of our lead asset as well as expanding our partnerships. Our CEO's letter to shareholders sets out the achievements of this year and we look forward to keeping you informed as we progress in 2025. You can find the letter here: https://lnkd.in/di4Gm_XE #healthcare #biotech

How does NCX 470, our de-risked compound in Phase 3 development for #glaucoma, work? And why can it offer potential benefits to patients? Data from our first pivotal trial, ‘Mont Blanc’, show that the dual mechanism of action of NCX 470 can achieve greater intraocular pressure (IOP)-lowering – the only clinically proven method to slow progression of glaucoma - compared to the standard or care, latanoprost. NO is a well-known small, naturally occurring signaling molecule that plays a key role in the regulation of the lowering of IOP through the primary outflow route, working via the trabecular meshwork. Bimatoprost, an established prostaglandin analog (PGA) also known as Lumigan®, primarily lowers IOP by increasing the outflow of aqueous humor through the uveoscleral pathway from the inner chambers of the eye. NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop, designed to leverage the potent effects in lowering of both NO and bimatoprost. It works by releasing NO and bimatoprost into the eye to lower IOP by two different pathways in patients with open-angle glaucoma or ocular hypertension.   You can see this explained in a video on our website: https://lnkd.in/d8HDbTTR. Results from Mont Blanc showed the IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost. Statistical non-inferiority was met vs. latanoprost in the primary efficacy analysis consistent with the efficacy requirements for approval in the U.S. In addition, 4 out of 6 timepoints demonstrated statistical significance in favor of NCX 470. We are now looking forward to seeing confirmation of this clinical profile with the results from the ongoing “Denali” Phase 3 trial, expected in Q3 2025. #Glaucoma #MedicalInnovation #Ophthalmology #NCX470 #Biotech 

Did you know that #glaucoma is the leading cause of irreversible blindness worldwide? Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. It affects about 3.5% of the global population, yet current treatment options can still lead to disease progression in many patients. Glaucoma is also largely underdiagnosed, including in Western countries where less than 50% of people affected are actually treated, which leaves an opportunity to improve the standard of care. Currently, reducing elevated intraocular pressure (IOP) remains the only way to slow progression of the disease. But, as many as 40% of patients fail to reach target IOP with existing monotherapies, risking disease progression and permanent vision loss. There continues to be an unmet medical need for a therapy with greater IOP-lowering efficacy that is both safe and well tolerated, like Nicox’s Phase 3 investigational drug NCX 470, despite that we have established first line therapies. #blindness #eyedisease #healthcare #biotech

Congratulations to our partner OcuMension Therapeutics for the first commercial sale of ZERVIATE® for allergic conjunctivitis in China! “The first commercial sale of ZERVIATE in China by our partner Ocumension, marks the next significant milestone in this broad collaboration initiated in 2018 and provides a new revenue stream for Nicox.” said Gavin Spencer, Chief Executive Officer of Nicox. You can find the full Press Release here: https://lnkd.in/dEecKmKW #DrugDevelopment #ProductLaunch

Today we have announced that enrolment in the Denali Phase 3 trial of NCX 470 in glaucoma has been completed and screening has been closed. “Following completion of the recruitment of the Denali trial in the United States, we have seen an acceleration in the number of Chinese patients randomized in this multi-center international trial, allowing us to close Chinese patient recruitment earlier than expected.” said Doug Hubatsch, Chief Scientific Officer of Nicox. The completion of enrollment confirms the Q3 2025 date for top-line results in this second phase 3 trial on our lead clinical candidate. You can find the full Press Release here: https://lnkd.in/d99PWfUh #Glaucoma #DrugDevelopment #ClinicalTrial

Publication today of the results of the adaptive design period of our Mont Blanc Phase 3 clinical trial on NCX 470 in a peer-reviewed journal. https://lnkd.in/gApSF3Gj

This morning we have reported our third quarter 2024 update and first half 2024 financial results: a period of significant strategic progress for Nicox in which we have stabilized our financial situation

We are pleased to announce a major financing with Soleus Capital Management, L.P. today.  Soleus invested $16.5 million in Nicox through a combination of Royalty and Equity Financing.    “The agreements announced today allow us to effectively monetize our VYZULTA revenue stream, creating an immediate source of cash to finance the development of our lead asset, NCX 470, whilst also bringing in a new, specialist investor, investing at a premium, to accompany our future development.” said Gavin Spencer, Chief Executive Officer of Nicox.    The Company is now financed into Q3 2025 and we also expect to have the results from the Denali Phase 3 clinical trial in Q3 2025.    We look forward to announcing the launch in China of ZERVIATE by our partner OcuMension Therapeutics following the approval in September, and to the completion of recruitment in China in the Denali trial.    You can find the full Press Release here:  https://lnkd.in/dZjncNKD   #glaucoma #biotech #financing  

Nicox has entered into an exclusive research and global license option agreement with Glaukos Corporation for NCX 1728, our novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitor.  “Glaukos possesses expertise in the treatment of ophthalmic disorders and has unique drug delivery capabilities which could optimize NCX 1728 for uses including reduction of intraocular pressure, neuroprotection and as a potential treatment for retinal diseases.” said Doug Hubatsch, Chief Scientific Officer of Nicox.   Glaukos will evaluate NCX 1728, at its cost, in a pre-clinical research program agreed between Nicox and Glaukos. The program will explore indications for the treatment of glaucoma, including neuroprotection, and in the treatment of retinal diseases. Glaukos has an option to license NCX 1728 on an exclusive global basis for development in these ophthalmic conditions, which can be exercised within certain specified periods, the first of which is in 12 months. Full details are in our Press Release: https://lnkd.in/dYFUkQ5u #glaucoma #biotech #businessdevelopment #partnering 

Nicox has entered into an exclusive research and global license option agreement with Glaukos Corporation for NCX 1728, our novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitor.  “Glaukos possesses expertise in the treatment of ophthalmic disorders and has unique drug delivery capabilities which could optimize NCX 1728 for uses including reduction of intraocular pressure, neuroprotection and as a potential treatment for retinal diseases.” said Doug Hubatsch, Chief Scientific Officer of Nicox.   Glaukos will evaluate NCX 1728, at its cost, in a pre-clinical research program agreed between Nicox and Glaukos. The program will explore indications for the treatment of glaucoma, including neuroprotection, and in the treatment of retinal diseases. Glaukos has an option to license NCX 1728 on an exclusive global basis for development in these ophthalmic conditions, which can be exercised within certain specified periods, the first of which is in 12 months. Full details are in our Press Release: https://lnkd.in/dYFUkQ5u #glaucoma #biotech #businessdevelopment #partnering