In just over a week Eli Lilly has gone from having nothing in the clinic to not one but now two antibody drugs targeting SARS-CoV-2 as it also eyes combining both, and more besides, for a more potent effect.
At the start of the month, Lilly began dosing COVID-19 patients in a phase 1 trial of its AbCellera-partnered antibody known as LY-CoV555; now, it’s kickstarting another phase 1 program with its second COVID asset, which is partnered with Chinese biotech Junshi Biosciences.
The experimental med, known as JS016, sees Junshi leading development in Greater China while Lilly has exclusive rights in the rest of the world. Dosing started in China today with a complementary phase 1 study in the U.S. to start “in the coming days.”
Both phase 1 studies aim to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy volunteers who have not had COVID-19.
This is Lilly’s second neutralizing antibody to start clinical trials, following LY-CoV555 that is currently being tested in hospitalized COVID-19 patients, and was the first antibody drug to start trials against the disease.
Lilly says it is already plotting a cocktail approach with these two antibodies. Because the meds bind to different epitopes on the spike protein, bringing them together could “expand the diversity of options for achieving efficacy and avoiding resistance,” the Big Pharma said in a statement.
It also plans to add these drugs to “additional antibodies currently in preclinical development,” in the hope that, as with other disease areas, such as cancer, combo therapies will boost efficacy.
“There is much we still don’t know about COVID-19,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.
“The best path to learn more about the potential for neutralizing antibodies, either as monotherapy or in combination, is through carefully controlled randomized trials. We look forward to the results of such trials in the coming months.”
By: Ben Adams
Source: Fierce Biotech
Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.
Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures. If approved, efgartigimod will be the first neonatal Fc receptor (FcRn) blocker for the treatment of adults in Europe living with rare neuromuscular disease generalized myasthenia gravis (gMG).
Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million).
