Swiss giant Novartis NVS and partner Molecular Partners announced the initiation of EMPATHY, a phase II and III study, to evaluate 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 while Molecular Partners will sponsor the studies.
Novartis has collaborated with Molecular Partners to develop two DARPin therapies — ensovibep and MP0423 — designed for potential use against COVID-19, with an option to in-license global rights from the latter and development responsibilities to both therapies.
Molecular Partners reported positive initial phase I results in healthy volunteers in March 2021.
The EMPATHY clinical trial program is evaluating 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 II to identify a dose with optimal safety and activity and the initial data from the phase II study is anticipated in August 2021.
Thereafter, the companies will move ahead with the phase III portion of the study with an additional 1,700 patients. Results from this portion are anticipated in the first half of 2022.
Novartis intends to seek expedited approval through the FDA’s Emergency Use Authorization (EUA), if the initial EMPATHY trial results are positive.
Meanwhile, the preclinical work for MP0423 is ongoing and being led by Molecular Partners.
Novartis will also be responsible for the manufacturing, distribution and commercialization of both therapies.
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 the development of the most promising COVID-19 therapies.
ACTIV-3 is a late-stage study that will evaluate 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 of 300 patients with mild-to-moderate disease.
We remind investors that Novartis also signed an initial agreement to manufacture the mRNA and bulk drug product for the vaccine candidate, CVnCoV, from CureVac CVAC, with plans to produce up to 50 million doses in 2021 and up to a further 200 million doses in 2022.
The stock has lost 6.3% in the year so far against the industry’s growth of 6.4%.
Regeneron (NASDAQ:REGN) Pharmaceuticals’ REGN antibody cocktail, REGEN-COV (casirivimab with imdevimab), has been given the FDA’s Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in adults, as well as pediatric patients at least 12 years of age.
Novartis currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the health care sector includes Repligen (NASDAQ:RGEN) Corp. RGEN, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 60 days.
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