Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19
- EMPATHY global multi-center Phase 2 - 3 study, recruiting patients with COVID-19 infection, aiming to prevent worsening symptoms and hospitalization
- The study plans to enroll 2100 patients, with 400 patients to be enrolled into Phase 2, followed by 1700 patients in Phase 3
- Novartis has been granted an option from Molecular Partners to in-license global rights of ensovibep and MP0423 - DARPin® antiviral therapeutic candidates that are undergoing testing to target SARS-CoV-2 spike protein
- DARPin® therapeutics well suited for a pandemic setting due to multi-specific target binding, long half-life for sustained activity and highly scalable production, compared to monoclonal antibodies
Basel, May 27, 2021 — Novartis and Molecular Partners announced today the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March 2021, Molecular Partners reported positive initial Phase 1 results in healthy volunteers.
The EMPATHY clinical trial program is investigating the safety and efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization. The study will enroll 400 patients in Phase 2 to identify a dose with optimal safety and activity, with initial results anticipated in August 2021. At that point Phase 3 will move ahead with an additional 1,700 patients with results anticipated in H1 2022. If the initial EMPATHY trial results are convincing, this would pave the way for Novartis to seek expedited approval via the FDA’s Emergency Use Authorization (EUA).
Those eligible for the EMPATHY trial are adults, over the age of 18, with a positive SARS-CoV-2 antigen test and who are experiencing at least two pre-determined mild/moderate symptoms of COVID-19 within 7 days of their diagnosis.
“Novartis remains unwavering in our efforts to help combat COVID-19, including our support to deliver treatment options for patients around the globe,” said Dr. Lutz Hegemann, Group Head, Corporate Affairs and Global Health, Novartis. “Today, with Molecular Partners, we’re announcing an important next step in the development of ensovibep, which holds promise to respond to breakthrough disease and new variants in the future. We are hopeful the results of this clinical trial program will provide a reliable treatment option for patients with COVID-19.”
Novartis believes a multi-solution strategy is needed to overcome COVID-19, one that utilizes a range of diagnostic and therapeutic options, depending on the needs of individual patients. Every country should have access to effective medicines to treat COVID-19 and despite availability of vaccinations, there continues to be disease transmission and there is likely to continue to be breakthrough disease.
“By virtue of its tri-specific design, ensovibep was built to resist viral mutations and indeed shows potent inhibition of all variants of concern to date, with the potential to maintain activity also for future variants. This type of broad spectrum activity is essential for any treatment of relevance for patients with COVID-19,” said Patrick Amstutz, Chief Executive Officer, Molecular Partners. “Reaching this important clinical milestone is not only a key step to combat this virus, but also validating our DARPin approach to generate multispecific antiviral therapies in the fight against global pandemics.”
Initial findings from the Phase 1 trial of ensovibep showed it to be safe and well tolerated with no significant adverse events. Predictable exposure was seen post-administration, confirming the expected half-life of two to three weeks. These data confirmed the systemic administration of a multi-specific DARPin antiviral therapy to be safe and well tolerated and support plans for additional clinical work in patients diagnosed with COVID-19, as part of the EMPATHY trial. The preclinical work for MP0423 is still ongoing and is being led by Molecular Partners.
Sustained binding against new variants of Covid-19
Molecular Partners, in collaboration with academic and government partners, has conducted in vitro experiments using pseudovirion models of SARS-CoV-2 to analyze for infectivity in the presence of ensovibep. These models represent new variants first identified in UK (B1.1.7), South Africa (B.1.351), Brazil (P.1), California (B.1.429), New York (B.1.526), emerging variants R.1 and A.23.1, the individual key mutations of the variants identified in India, B.1.617 and B.1.618, and other key spike mutations identified to date. The results suggest ensovibep continues to retain full potency against the new viral variants of SARS-CoV-2, and could have the potential for sustained binding to additional COVID-19 variants, as they may appear in the future.
Ensovibep enrollment in ACTIV-3 trial
Molecular Partners and Novartis also recently announced the inclusion of ensovibep in the NIH-Sponsored ACTIV-3 Trial (National Institute of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program) that aims to prioritize and push forward development of the most promising COVID-19 therapies. ACTIV-3 is a global Phase 3 trial that will investigate the safety and efficacy of ensovibep in adults hospitalized with COVID-19, with an aim to enroll up to 1,000 patients. The first patient dose is expected to be administered in June 2021, with an interim analysis after 300 patients with mild-to-moderate disease. These patients will receive either ensovibep or a placebo. Trial participants will also receive an existing standard of care for COVID-19, including the FDA-approved antiviral remdesivir. If the treatment has a positive risk-benefit profile, the study will enroll an additional 700 patients for further testing. Ensovibep is the first non-antibody therapy assessed in ACTIV-3, supporting a different approach for COVID-19 treatment.
The collaboration with Molecular Partners
Novartis is proud to be collaborating with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19, ensovibep and MP0423, with an option to in-license global rights from Molecular Partners and development responsibilities to both therapies. Novartis will also be responsible for manufacturing, distribution and commercialization of both therapies.
The development program will be led by Molecular Partners until Phase 1 is complete and will be handed over to Novartis to conduct the pivotal clinical trial EMPATHY, with Phase 2 and 3 trials, with Molecular Partners as sponsor of these trials. Molecular Partners will perform all remaining preclinical work for MP0423.
Novartis response to the COVID-19 pandemic
Novartis is making a number of contributions to the global fight against the COVID-19 pandemic and supporting the stability of global health systems. The company recently announced initial agreements to provide manufacturing capacity for a COVID-19 vaccination for BioNtech at its site in Stein, Switzerland and for CureVac in Kundl, Austria. In addition, Novartis has signed an initial agreement to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra. Novartis is committed to donating US $40 million to help communities affected by the pandemic around the world.
In addition, Novartis is active in several key cross-industry research initiatives, the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard as well as a COVID-19 directed partnership supported by the Innovative Medicines Initiative (IMI). Novartis has also announced this collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. The company is separately supporting COVID-19-related clinical investigations of several Novartis medicines. In our labs, we have started a collaborative, longer-term drug discovery effort to develop the first oral medicines for COVID-19 and other coronaviruses. To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines. We are making 15 drugs that treat key symptoms of COVID-19 available to low-and lower-middle income countries at zero profit until a vaccine or curative treatment is available. Furthermore, Novartis Gene Therapies entered into a manufacturing agreement with Massachusetts Eye and Ear and Massachusetts General Hospital to produce its novel genetic COVID-19 vaccine candidate called AAVCOVID8. More information about the Novartis response to COVID-19 is available at www.novartis.com/COVID-19.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact firstname.lastname@example.org
# # #
Novartis Media Relations
| Michael Meo|
US External Engagement, Novartis
+1 862 274 5414
Novartis US External Communications
+1 862 579 8456
| Arzum Ustun|
Communications, Novartis Corporate Affairs and Global Health
+41 79 108 5314
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
|Samir Shah||+41 61 324 7944||Sloan Simpson||+1 862 778 5052|
|Thomas Hungerbuehler||+41 61 324 8425|
|Isabella Zinck||+41 61 324 7188|
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Data analysis from dLab to boost the digitalization for Karlskoga Energi & Miljö24.6.2021 09:55:00 CEST | Press release
Regional utilities company Karlskoga Energi & Miljö AB has been using the smart data analytics solution from cleantech company Dlaboratory Sweden AB (publ) since 2020. A useful solution for avoiding power outages and identifying faults, dLab’s system is the starting point for the energy company’s digitalization journey. Energy company Karlskoga Energi & Miljö with its subsidiary Karlskoga Elnät has around 15 000 customers along a 1 700 km grid in the middle of the beautiful region of Värmland. Digitalization is a high priority throughout the organization, whether it means providing fiber optics for consumers, or the dInsight Analytics Platform from dLab. -The solution from dLab pushes us to work in a completely new way; from monitoring and analysis to becoming proactive, using data to prevent, rather than fix a problem. This requires new knowledge in the organization, but also a new way of working, says Jimmy Lundberg, Head of Distribution at Karlskoga Elnät. The company chose dLab’s s
Nokia launches next-generation AirScale 5G portfolio powered by ReefShark technology24.6.2021 09:00:00 CEST | Press release
Press Release Nokia launches next-generation AirScale 5G portfolio powered by ReefShark technology Nokia’s new, industry-leading 5G portfolio covers baseband, radio, and massive MIMO antennas offering huge 5G capacity, coverage, and easy deploymentIntroduces industry’s lightest massive MIMO units at 17kg enabling simplified deployments and faster time to marketNokia’s new comprehensive range of products are powered by Nokia’s latest generation of ReefShark chipsets Nokia’s extended Single RAN accelerates 5G rollouts and cuts overall RAN Total Cost of Ownership 24 June 2021 Espoo, Finland – Nokia today announced the global launch of its latest range of industry-leading AirScale 5G products covering baseband, remote radio heads, and massive MIMO active antennas with digital beamforming. The innovative solutions are powered by the latest generation of Nokia’s ReefShark System-on-Chip (SoC) chipsets and deliver the highest capacity and network performance while enabling efficient deploymen
Huvepharma Announces the Indicative Price Range, Publication of the Prospectus and Start of the Offer Period of Planned IPO24.6.2021 08:15:39 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION IN VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION. This announcement is an advertisement for the purposes of the Prospectus Regulation EU 2017/1129 and underlying legislation, relating to the launch of the Offer (as defined below) by the Company and the proposed Admission (as defined below). This announcement does not constitute a prospectus. This announcement is for information purposes only and is not intended to constitute, and should not be construed as, an offer to sell or a solicitation of any offer to buy Shares (as defined below) in any jurisdiction, including the United States, Canada, Australia or Japan. Further details about the Offer and the Admission is included in the Prospectus (as defined below). The Prospectus has today been approved by the Netherlands Authority for the Financial Markets (Stich
FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)24.6.2021 07:00:00 CEST | Press release
If approved, PDS would be the first and only eye implant with continuous drug delivery that offers people living with nAMD an alternative to frequent eye injectionsA pivotal study showed PDS extends time between treatments up to six months for more than 98% of patients and provides vision outcomes equivalent to monthly ranibizumab injectionsThe European Medicines Agency has also validated the PDS Marketing Authorisation Application in nAMD Basel, 24 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Neovascular AMD is a leading cause of blindness for people aged 60 and over and impacts approximately 20 million people worldwide.1,2,3 If approved, PDS would be a first-of-its-kind therapeutic approach, offering pe
ObsEva To Present Data on Two Clinical Development Programs at ESHRE Virtual 37th Annual Meeting24.6.2021 07:00:00 CEST | Press release
- Data from Phase 3 study ofYselty® (linzagolix) for the treatment of uterine fibroids to be discussed in an oral presentation; Top-line data from pilot study of Yselty for the treatment of severe adenomyosis to be presented in an ePoster- -Data from IMPLANT1 Phase 2 study of nolasiban for uterine contractility of IVF patients prior to embryo transfer to be presented in an ePoster - GENEVA, Switzerland and BOSTON– June 24, 2021 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of data from two of its clinical development programs at the European Society of Human Reproduction and Embryology (ESHRE) Virtual 37th Annual Meeting, being held June 26 - July 1, 2021. Details of the presentations for the Yseltyprogram are as follows: Title: Long-Term Secondary Efficacy of Linzagolix for Heavy Menstrual Bleeding (HMB) Due to Uterine Fibroids (UF): 52-Week Res
Hyloris Successfully Renegotiates License Agreements for Lead Products with the Alter Pharma Group24.6.2021 07:00:00 CEST | Press release
Acquires all royalty rights to Maxigesic® IV Assumes sole responsibility for HY-075 and HY-038 – future profit split lapses Gains higher net profit margin for Fusidic Acid Cream in Canada Hyloris CEO and CBDO to resign from the Board of Directors of Alter Pharma Liège, Belgium – 24June 2021 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to bringing innovative treatments that offer added value to underserved patient populations, today announces that it has successfully renegotiated and unwound its earlier license agreements with the Alter Pharma Group. Hyloris will pay the Alter Pharma Group a total lump sum of €5.25 million plus €0.5 million potential earn-out, thereby waiving any further future financial obligations towards the Alter Pharma Group. Hyloris Pharmaceuticals and the Alter Pharma Group have amended and unwound the earlier license agreements as follows: The patent and knowhow license agreement in relation to Maxigesic IV has b
Enento Group makes a strategic investment to add a unique Sales Intelligence service offering by acquiring a part of Goava Sales Intelligence AB with possibility to take majority24.6.2021 07:00:00 CEST | Press release
ENENTO GROUP PLC, STOCK EXCHANGE RELEASE ON 24 JUNE 2021 AT 8.00 A.M. EEST Enento Groupmakes a strategic investment to add a uniqueSales Intelligence service offering byacquiring apart of Goava Sales Intelligence AB with possibility to take majority Enento Group Plc has signed an agreement to acquire part of and become the largest shareholder of the Swedish sales intelligence services company Goava Sales Intelligence AB by subscribing to new preference shares in the company. Within the agreement, Enento in the first stage on 24 June 2021 acquires a 38,3 % (35,1 % fully diluted) shareholding in the company, and at the same time agrees to complete subsequent preference share subscriptions provided that the company fulfills certain preconditions laid out in the business plan, as well as acquires a purchase option to acquire all outstanding shares in the company after a mutually agreed business plan period ending in year 2024 and aiming at gaining a significant market position for the serv