NGM shares plunge as Merck-partnered eye drug fails Phase 2 test – BioPharma Dive

The biotech could search for a new partner for the geographic atrophy drug if Merck decides not to license it under an existing deal, executives said on a conference call.
An experimental drug from NGM Biopharmaceuticals failed to meaningfully slow signs of disease progression in patients with an irreversible eye condition known as geographic atrophy, a setback that sent the biotechnology company’s shares tumbling to a record low.
After a year of treatment with the drug, an antibody called NGM621, patients in a Phase 2 trial who received a once-monthly dose saw a roughly 6.3% reduction in the growth rate of retinal lesions, or scar tissue, in their eyes. A dose given once every two months led to a 6.5% slowing of lesion growth. Neither result was meaningfully better than a sham injection, NGM said on Monday.
The company added that the drug demonstrated a “favorable” safety profile, with no drug-related serious adverse events and numerically fewer cases of choroidal neovascularization — when harmful new blood vessels form in the eye — among those on treatment. Executives on a conference call Monday also pointed to better results when excluding a subset of patients with the largest lesions at the start of the trial. However, that exploratory analysis doesn’t change the trial’s outcome, leaving the fate of the program unclear.
“It’s just too early to be definitive about next steps,” NGM CEO David Woodhouse said on the call. The company will look through study details and evaluate the program with its longtime partner Merck & Co, which holds an option to license NGM621, he added.
NGM would likely look for a new partner if Merck opts not to license, according to Siobhan Nolan Mangini, the company’s president and chief financial officer.
NGM shares fell 73% to about $3 apiece in early trading Monday. The company went public in 2019 at $16 per share.
Geographic atrophy results from age-related macular degeneration, where damage to the macula — the part of the eye responsible for central vision — causes progressive vision loss. Retinal cells waste away and die, forming the patchy eye lesions that characterize the disease.
There are no medicines available that stop the degradation of vision in people with GA, but that could soon change. Two injectable drugs that block activation of the complement system, a part of the body’s initial response to foreign threats, are either being evaluated by the Food and Drug Administration or soon will be. Those drugs, from Apellis Pharmaceuticals and Iveric Bio, have shown they can reduce lesion size in clinical testing, though they haven’t proven those benefits translate to preserved or improved vision.
Multiple analysts and executives have said they expect those benefits to eventually materialize with time. However, the FDA could make decisions beforehand. A decision on Apellis’s drug is expected by Nov. 26. Iveric has said it should finish an approval application next year.
Their progress has bolstered the outlook of other companies developing similar drugs. One of them is NGM, whose treatment, like Apellis’s, targets a component of the complement pathway called C3. A monthly injection of Apellis’s drug showed a 22% reduction in lesion growth after a year in one successful Phase 3 study and a 12% decline in a second, unsuccessful late-stage trial. Iveric reported an average 14% or 18% reduction, depending on the statistical measurement.
Analysts had been expecting NGM’s drug to perform similarly. Instead, the company believes the few patients with “very large, very complex lesions … caused variability” in the results, Chief Medical Officer Hsiao Lieu said on the conference call. More details will be presented at a medical meeting in November.
Merck has “about a quarter” to decide whether to license NGM621, Nolan Mangini said. Merck is also working with the biotech on two preclinical eye drug programs and early cardiovascular research. Additionally, it’s running a mid-stage trial on a drug NGM discovered for the fatty liver disease nonalcoholic steatohepatitis, or NASH. A different NGM drug candidate failed a study in NASH in 2021.
Get the free daily newsletter read by industry experts
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.
Keep up with the story. Subscribe to the BioPharma Dive free daily newsletter
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
Keep up with the story. Subscribe to the BioPharma Dive free daily newsletter
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
Subscribe to BioPharma Dive for top news, trends & analysis
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
Get the free daily newsletter read by industry experts
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.
The free newsletter covering the top industry headlines
Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.

source

Add a Comment

Your email address will not be published. Required fields are marked *