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

Kenetic Bucks Crypto Market Trend with YTD 77% Returns in Investment Portfolio14.11.2018 10:37Tiedote

Kenetic, a blockchain investment and advisory firm based in Hong Kong, has revealed that its proprietary investment portfolio has recorded year-to-date returns of 77 percent as of October 31, 2018, against a backdrop of major losses in the cryptocurrency market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113006323/en/ After hitting its record high in December 2017, Bitcoin has fallen over 50 percent in 2018 and the overall crypto market is down around 65%. Kenetic’s proprietary investment portfolio is comprised of its best ideas that have undergone thorough due diligence by its experienced investment team. Its alpha-generating strategies are largely focused on early stage investments, catalyst driven events and macro themes, complemented by prudent risk management and proprietary in-house trading tools. “As active leaders in the global blockchain community, we see where the strongest investment opportunities lie and r

Smiths Detection State-of-the-Art Checkpoint Lanes Chosen for Israeli Airports14.11.2018 10:30Tiedote

Smiths Detection and its local distributor, Eastronics, have been selected by the Israel Airport Authority (IAA) to supply 32 advanced checkpoint lanes for Ben Gurion Airport and the new Ramon International Airport, which is due to open in 2019. These latest, highly functional lane designs from Smiths Detection incorporate automated tray return and diversion and were developed to improve operational efficiency and passenger experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113005810/en/ “Automation plays a key role in streamlining screening by literally keeping things moving and the result is increased throughput, lower per capita costs and a passenger friendly process,” explained Tony Tielen, Vice President EMEA, at Smiths Detection. “With the help of Eastronics, we were delighted to be able to meet IAA’s stringent requirements for this extensive project, which could have a significant impact on maintaining flow

CHTF 2018 Opens, Gathering Global Enterprises and Entrepreneurs14.11.2018 09:00Tiedote

The 20th China Hi-Tech Fair (CHTF 2018) kicked off at the Shenzhen Convention and Exhibition Center on November 14, 2018. By showcasing cutting-edge high-tech products and technologies of enterprises and institutions from around the world, CHTF 2018 remained a trend setter in the high-tech industry. A large number of technology companies have emerged from CHTF in the past two decades. In its 20th year, CHTF 2018 attracted the world's top experts and scholars, and gathered multinational corporations, Fortune 500 companies and unicorn enterprises to showcase the latest technical developments. Chinese giants included China Mobile, China Unicom, China Telecom, China Electronics, CRRC; multinational companies included Suez, Foxconn, Ricoh, Baidu, Tsinghua Tongfang, TCL, Sogou, BOE; unicorn enterprises included SenseTime, iQiyi, Royale, Orbbec, Qiniu Cloud, BITMAIN, etc. In addition, three leading AI chip companies, namely Cambrian, Horizon Robotics and Deephi Tech, were also involved. The C

Kalray Releases the Kalray Neural Network 3.0 (KaNN) to Accelerate Artificial Intelligence Application Development13.11.2018 21:26Tiedote

Kalray (Euronext Growth Paris – ALKAL), a pioneer in processors for new intelligent systems, today announced the launch of the Kalray Neural Network 3.0 (KaNN), a platform for Artificial Intelligence application development. KaNN allows developers to seamlessly port their AI-based algorithms from well-known machine learning frameworks including Caffe®, Torch® and TensorFlow® onto Kalray’s Massively Parallel Processor Array (MPPA®) intelligent processor. Artificial Intelligence is at the heart of a growing number of applications such as autonomous vehicles, intelligent storage servers, data centers, robotics, drones, and more. Kalray’s manycore MPPA® intelligent processor has been architected from the ground up to meet the incredible performance requirements of such advanced applications. However, it is crucial to provide an easy way for AI developers to seamlessly support the AI networks they develop. “The Kalray MPPA® intelligent processor is capable of processing massive amounts of d

Sharjah International Book Fair 2018 Celebrates Reading and Culture with 2.23 Million Visitors13.11.2018 21:17Tiedote

The world’s third largest celebration of the written word, the Sharjah International Book Fair (SIBF), has put up yet another record performance in its 37th annual edition. Themed ‘A Tale of Letters’, the event was a dream come true occasion for book lovers, who had access to 20 million books, all under one roof. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113006044/en/ Sharjah International Book Fair 2018 - Provided by Sharjah Book Authority (Photo: Business Wire) Organised by the Sharjah Book Authority (SBA) in the emirate of Sharjah, cultural capital of the United Arab Emirates (UAE), SIBF 2018 witnessed a footfall of 2.23 million visitors in 11 days, including 230,000 school students who poured in from around the country. The Sharjah International Book Fair hosted 1,874 publishers from 77 countries who brought in 1.6 million titles, 80,000 of which were seen at the fair for the first time. It also offered its stage

Communications and Business Transformation Strategist Brian Ellner Joins BCW to Lead U.S. Corporate Practice13.11.2018 21:00Tiedote

BCW (Burson Cohn & Wolfe), a leading global communications agency, announced today that Brian Ellner has joined as Executive Vice President, Global Corporate Solutions, responsible for leading and growing BCW’s U.S. Corporate Practice. Ellner takes on the role previously held by Aranthan “AJ” Jones II, who will now lead the firm’s Public Affairs and Crisis Practice in the U.S. “Corporations are navigating an increasingly complex world where their reputations are tied not only to their own performance but also to their behavior on topics like climate, gender pay equity, visa status, diversity and inclusion and the environment,” said Chris Foster, President, North America, BCW. “Brian has deep experience helping clients build and protect their reputations, manage business transformation and create authentic social purpose engagements. He is a seasoned strategic counselor and power player in the New York business world and will bring our clients and our business clear opportunities for gr

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