Business Wire

MC2 Therapeutics Announces Topline Results Showing a Favorable Safety Profile and Reduction in Corneal Staining for MC2-03 in Dry Eye Patients with Moderate to Severe Keratitis

Jaa

MC2 Therapeutics A/S, a clinical-stage dermatology and eye care company, today announced topline results from the MC2-03-C1 Northern Lights Phase 2 trial evaluating the safety and efficacy of MC2-03 (PADciclo™) in moderate-to-severe dry eye (DED) patients. MC2-03 is an eye drop containing ciclosporin (CsA) formulated using MC2 Therapeutics’ proprietary PAD™ Technology to enable improved penetration into ocular tissues without the use of excipients that can cause ocular safety concerns. Topline results will be presented at the Ophthalmology Innovation Summit (OIS) in Chicago on October 25th, 2018.

In this randomized, double-masked, parallel arms, controlled six-month trial enrolling 263 adult patients, two active treatment arms (MC2-03 0.06% CsA and MC2-03 0.03% CsA) were compared to two control arms (MC2-03 vehicle and lubricant) as an add-on therapy to a standard-of-care lubricant. The trial was powered to evaluate safety and efficacy of the individual treatment arms, and to potentially show significant differences between the combined MC2-03 active arms versus the combined control arms.

The primary efficacy variable was the proportion of patients achieving 2-grade improvement in corneal fluorescein staining (CFS) on the modified Oxford scale at Month 6 (defined as CFS responders), which is recognized by regulatory authorities and experts as being clinically and medically relevant. The active arms MC2-03 0.06% CsA (n=68) and MC2-03 0.03% CsA (n=66) showed a similar and consistent trend for a higher proportion of CFS responders than MC2-03 vehicle (n=58) and lubricant (n=63) (full analysis set, n=255). A significant difference between MC2-03 0.06% CsA versus lubricant was observed when comparing patients with CFS response in both eyes (43.1% vs 22.8%, p=0.0289), which was confirmed when comparing the combined MC2-03 active arms to the combined control arms (39.5% vs 26.1%, p=0.0358).

Among the severe population (a total of 108 patients), 58 patients were randomized to the combined MC2-03 active arms. This group of patients with severe keratitis appeared to benefit more from active treatment as significantly more patients treated with active MC2-03 were CFS responders compared to the combined control arm (58.0% vs 31.3%, p=0.0090). This finding was confirmed in severe patients having CFS response in both eyes (42.0% vs 18.8%, p=0.0161), and further supported by the secondary endpoint variable Change in CFS from Baseline to Month 6 in the worse eye (p=0.0496).

The clinically and medically relevant improvement of corneal staining shown with active MC2-03 was substantiated by a comprehensive analysis of inflammatory biomarkers by impression cytology, including a significant difference observed in favor of MC2-03 0.06% CsA over MC2-03 vehicle in the reduction of HLA-DR positive cells from Baseline to Month 6 (p=0.028). HLA-DR is one of the best validated biomarkers of inflammation on the ocular surface and shown to be correlated to DED progression.

An attractive safety profile was confirmed across all arms with no serious adverse events reported to be related to the study medication (safety population, n=263). The most common adverse events related to the active arms MC2-03 0.06% CsA and MC2-03 0.03% CsA were ocular with few observed events of eye pain and eye irritation as the most common, confirming favorable tolerability of MC2-03 in this moderate-to-severe patient group.

The results of the MC2-03-C1 Northern Lights trial are positive and extremely promising, especially in the most severe population where results go beyond our initial expectations” stated Jesper J. Lange, President of MC2 Therapeutics and he added: “In addition to our recently announced positive US Phase 3 results on MC2-01 PAD™ Cream for topical treatment of psoriasis these results underpin the ability of PAD™ Technology to redefine topicals”.

Professor, Consultant, MD DMSc Steffen Heegaard, University Hospital Rigshospitalet, the coordinating principal investigator in the trial commented: “There is still a need for new modalities in the treatment of severe dry eye disease as patients remain insufficiently managed despite an approved therapy. Importantly, MC2-03 was well-tolerated in the trial and has shown the potential to provide robust and clinically meaningful treatment for this underserved patient group.

As soon as the full assessment of the data is completed, MC2 Therapeutics will discuss safety and efficacy data with regulatory agencies.

About MC2 Therapeutics A/S

MC2 Therapeutics A/S is a privately held clinical-stage dermatology and eye care company. Using its proprietary PAD™ Technology – a new class of vehicle – MC2 Therapeutics is developing a pipeline of new highly efficacious topical therapies designed for unique patient experiences.

For additional information on MC2 Therapeutics Group, please visit www.mc2therapeutics.com

Contact information

MC2 Therapeutics A/S
Investors:
Jesper J. Lange, +45 2018 2222
jjl@mc2therapeutics.com
or
Media ex-Denmark:
ICR Healthcare
James Heins, +1 203-682-8512
james.heins@icrinc.com
or
Darcie Robinson, +1 203-682-8379
darcie.robinson@icrinc.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

ClickFellas Chooses Digital Element to Increase Accuracy of IP Geotargeting Services25.6.2019 11:02:00 EESTTiedote

Digital Element, the global geolocation data and services provider, today announced that ClickFellas, a new advertising technology company, has chosen its NetAcuity EdgeTM technology to improve ad targeting for its clients. By incorporating Digital Element’s technology, ClickFellas is able to identify the consumer’s location, internet service provider, connection speed, mobile carrier, organisation name and proxy type without the user becoming personally identifiable. This highly accurate and granular IP data is used to facilitate standalone geotargeting and, when combined with additional factors such as gender, purchase intent and history data, allows Clickfellas to create tighter targeting profiles. Additionally, proxy data is used to help combat click fraud. “Digital Element’s technology helps us not only improve the accuracy of geotargeted advertising being served but also, ensures that we limit fraudulent traffic,” commented Franz Kanehl, Co-Founder ClickFellas Ltd. “For us, the b

Banque du Caire, One of the Largest State-owned Banks in Egypt, Goes Live With Temenos to Redefine Digital Customer Experience25.6.2019 11:00:00 EESTTiedote

Temenos (SIX: TEMN), the banking software company, today announces that Banque du Caire has gone live with Temenos Infinity, the omni-channel digital banking product to transform the bank’s multiple banking channels into a fast, seamless and compelling customer journey. At this first stage of the Temenos Infinity implementation, the bank has gone live with digital channels servicing corporate and retail customers. The second phase of the implementation will deliver enhanced customer engagement with the Temenos Infinity real time marketing, digital engagement and digital analytics modules. Temenos Infinity will allow Banque du Caire, which currently operates a network of 225 branches, to increase product agility and take new products and services quicker to market. Temenos Infinity was implemented through APIs as an independent front office platform on the bank’s existing third party core banking system. The bank is also undergoing a core banking system overhaul after choosing the cloud

iD Mobile Signs New MDS Global Contract to Take Advantage of Cloud-Based BSS Solution25.6.2019 11:00:00 EESTTiedote

MDS Global Ltd, a leading BSS-as-a-Service provider today announced that iD Mobile, one of the UK's largest mobile virtual network operators, has engaged in a new contract with the company, adopting MDS Global's CMP 8, a fully cloud-enabled Monetisation Platform designed to scale on-demand for new subscriber and business growth. Seeking greater flexibility to integrate social media and other self-serve and community applications, and to take advantage of the benefits of using Google's Cloud infrastructure, iD Mobile's move to MDS Global's CMP 8, the BSS-as-a-service platform that underpins the company's VNOnDemand solution, offers on-demand scalability for growth. Fully enabled for any public or private environment, iD Mobile can deploy new features and services within hours, keeping with the demands of today's feature-hungry consumers. The UK-based MVNO, offers customers an online and app-based portal giving them the freedom to tailor their iD Mobile package based on consumption requi

Tech Veteran Tej Kohli Calls for a Democratisation of AI25.6.2019 11:00:00 EESTTiedote

Tej Kohli, the London-based tech investor and entrepreneur, says that the hype around AI is still premature and that too much hype is creating a “bubble of enthusiasm” that risks causing disillusionment amongst the public when AI products do not start quickly improving their lives as promised. He says that AI will only be able to change the world when there is an accessible user interface which enables more entrepreneurs to build AI products that can enable all people to access the full benefits of the AI economy. This will require concerted international collaboration as well as major capital investment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190625005075/en/ Tej Kohli is a prominent investor in the global artificial intelligence economy (Photo: Business Wire) Kohli is ebullient about the prospects of AI to build a better world and has reiterated his belief that an exponential global AI economy could be worth $150 t

Eneco Holdings, Inc. to Spark Fuel Revolution with Low-Price, High-Concentration, Scalable Hydrogen-generation Technology25.6.2019 10:30:00 EESTTiedote

Eneco Holdings, Inc. is committed to the research and development of eco-friendly fuel technologies that reduce emissions of greenhouse gases. In 2015, we developed an emulsion fuel that achieves a complete fusion of 50% oil and 50% water. When used to drive buses on public roads, this fuel cuts carbon dioxide emissions roughly in half—the first achievement of its kind in Japan. This highly acclaimed technology is already installed and operating in Indonesia, Bangladesh, and the Philippines, and is set for introduction in Singapore, Australia, China, Laos, and Myanmar. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190625005393/en/ The Press Conference (Photo: Business Wire) Given the urgency of reducing greenhouse gas emissions worldwide, Eneco Holdings, Inc. has turned its attention to hydrogen gas in a bid to drive the transition to a zero-carbon economy. Although hydrogen fuel has already captured worldwide attention as

QD Laser, Inc.: Development of New Types of Retinal Scanning Laser Displays with Lower Cost and Smaller Size25.6.2019 10:00:00 EESTTiedote

QD Laser, Inc. (Head office: Kawasaki City, Kanagawa Prefecture; President: Mitsuru Sugawara, hereinafter referred to as QD Laser) has succeeded in developing an innovative new retinal scanning laser displays by utilizing QD Laser’s proprietary retinal scanning projection technology. At the LASER World of PHOTONICS 2019 (Munich, Germany, June 24-27, 2019), two world premier prototypes will be exhibited and demoed. Summary QD Laser has succeeded in developing an innovative new retinal scanning laser eyewear by utilizing QD Laser’s proprietary retinal scanning projection technology. We have realized very inexpensive and miniaturized laser eyewear by combining our proprietary optical technology named VISIRIUM® technology with existing pico-projectors, At the LASER World of PHOTONICS 2019 (Munich, Germany, June 24-27, 2019), two prototypes will be exhibited and demoed. Background QD Laser has developed a laser retinal scanning technology named "VISIRIUM® Technology" that draws images direc

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme