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

Velodyne Demonstrates Lidar Solution for Rich Perception Data Collection on NVIDIA DRIVE Platform19.3.2019 04:00:00 EETTiedote

Velodyne Lidar, Inc. today announced its surround-view lidar solutions for collecting rich perception data in testing and validation are available on the NVIDIA DRIVE™ autonomous driving platform--allowing full, 360-degree perception in real time, facilitating highly accurate localization and path-planning capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005791/en/ Proven through learning from millions of road miles, Velodyne sensors help determine the safest way to navigate and direct a self-driving vehicle. (Photo: Business Wire) Velodyne sensors’ characteristics are also available on NVIDIA DRIVE Constellation™, an open, scalable simulation platform that enables large-scale, bit-accurate hardware-in-the-loop testing of AVs. The solution’s DRIVE Sim™ software simulates lidar and other sensors, recreating a self-driving car’s inputs with high fidelity in the virtual world. “Velodyne and NVIDIA are at the f

Western Union Teams Up with Thunes to Expand Payout Capabilities to Mobile Wallets19.3.2019 04:00:00 EETTiedote

Western Union (NYSE: WU), a leader in cross-border, cross-currency money movement, has teamed up with Thunes, a cross-border payments network for emerging markets, to enable Western Union customers to send funds directly into mobile wallets around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005639/en/ Senders can now utilise Western Union’s growing digital network or an agent location to send funds directly into a recipient’s mobile wallet. “We are continuously expanding and enhancing our account payout portfolio, providing customers with multiple payout options including bank accounts, cards or mobile wallets,” said Sobia Rahman, Global Head of Account Payout Network for Western Union. “Our goal is to make digital money transfer services more accessible, with a specific focus on enabling mobile transactions.” The collaboration will enable greater financial access for consumers - especially those who lack

Kohler Celebrates the Details of Design at Milan Design Week 201919.3.2019 03:22:00 EETTiedote

Kohler, a global lifestyle brand, returns to Milan Design Week to host an enticing sensory experience inside the historic Palazzo Del Senato (via Senato, 10, 20121 Milan, Italy). The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installation will be open April 9 through April 13 from 10am – 7pm daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005858/en/ The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installations feature global debuts of products from KOHLER, KALLISTA, ANN SACKS and ROBERN. (Photo: Business Wire) “Milan Design Week is the ultimate celebration of creativity and innovation among the global design community,” said Jim

ams and Wise Road Capital Advance Further Development for Environmental, Flow and Pressure Sensors Through Creation of a Joint Venture19.3.2019 03:09:00 EETTiedote

ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, and Wise Road Capital, a global Private Equity firm focusing on the semiconductor industry and other emerging high-tech industries, announce today that they have signed an agreement to create a joint venture to advance the development and sales of environmental, flow and pressure sensor solutions for the global market. Under the agreement, employees, IP, sensor products and solutions and related customers will transfer from ams to the joint venture, while Wise Road Capital will provide its expert joint venture guidance, deep market knowledge and strength in channel and customer relationships, especially in China. ams will transfer its current environmental sensor solution portfolio covering air quality, relative humidity and temperature sensing, which are used in automotive, smart building and air quality monitoring infrastructure applications. In addition, the ams ultrasound-based flow sensor solutions,

The We Company FY 2018 Financial Results Conference Call19.3.2019 02:44:00 EETTiedote

WeWork Companies Inc. (the “Company”), as issuer of its 7.875% Senior Notes due 2025 (the “Senior Notes”), will hold a conference call on Monday, March 25, 2019, at 5:00 P.M. Eastern Time for the benefit of certain qualified participants in order to discuss the Company’s financial results for the fiscal year 2018. Current holders and beneficial owners of the Senior Notes, bona fide prospective purchasers of the Senior Notes who are qualified institutional buyers (as defined in Rule 144A under the Securities Act of 1933) or non-U.S. persons (as defined in Regulation S under the Securities Act of 1933), securities analysts, and market-making financial institutions may gain access to the call information for the conference call by registering on the Company’s secure website at investors.wework.com. Additional information about the call (including dial-in number) will be provided on the secure website. Parties requesting access to the Company’s secure website will be required to provide ce

FANCL Regains Control of Their IT Roadmap by Switching to Rimini Street Support for its SAP Application19.3.2019 02:00:00 EETTiedote

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that FANCL, a leading additive-free cosmetics and health food products company in Japan, has switched to Rimini Street support for its SAP ECC 6.0 system. Rimini Street has enabled FANCL to take full control of their ERP roadmap and chart its direction based on the company’s business needs -- like advancing their digital transformation initiatives -- versus continuing to follow a vendor-dictated roadmap. Additionally, FANCL now receives premium-level, ultra responsive support for its current, stable SAP system for a minimum of 15 years from the time the company transitioned to Rimini Street. The company also immediately realized savings of 50 percent in annual support fees. FANCL is able to reinvest this significant cost saving into updating and modernizing the company’

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