Almost two months after getting the NIH ACTIV-3 study kick-off on a failed futility analysis, Novartis and Molecular Partners are back with mid-term results they say prove their Covid-19 antiviral works best in patients who aren’t hospitalized – and CEO Vas Narasimhan loves what he sees.
Pharmaceutical giant invests more than $ 162 million in ensovibep license from Molecular Partners after candidate met their primary endpoint of eight-day viral load reduction in the first part of a Phase II / III study, have announced on Monday the partners.
Molecular Partners’ $ MOLN stock saw a roughly 20% increase on the news, priced at $ 19.92 on Monday morning.
However, partners have yet to reveal concrete data on the primary endpoint. In fact, the only data point they reported on was a 78% reduction in the risk of Covid-related hospitalization, emergency room visits, and death compared to placebo (a secondary endpoint), which Molecular COO and co-founder Michael Stumpp said statistically significant. If you remove emergency room visits from that equation, the antiviral reported an 87% reduction in the risk of hospitalization and death compared to placebo, CEO Patrick Amstutz said.
A total of 407 outpatient adults with Covid-19 were included in part A of the phase II / III EMPATHY study, which tested three different doses of ensovibep (75 mg, 225 mg and 600 mg). In the placebo arm with 99 patients, there were six events (6.0% event rate); five patients were hospitalized, two of whom died from the worsening of Covid-19, and one patient only had one visit to the emergency room. But only four of 301 patients in the ensovibep arm (1.3%) saw such events, and no patient in the ensovibep arm died, according to Novartis.
The researchers also reported a time benefit for sustained clinical recovery, another secondary endpoint, which Stumpp said was statistically significant. More data will be presented at a scientific congress later this year, said a spokesperson for Novartis News from terminals.
Ensovibep maintained “powerful in vitro panvariant activity against all variants of concern identified so far, including Omicron, ”Novartis said in a statement.
The pharmaceutical company has chosen to proceed with the lowest dose, 75 mg, and aims to enroll an additional 1,700 patients in Part B, the phase III portion of the study. But even without the Phase III data, Narasimhan is already talking about his intention to file an EUA application.
“We are currently reviewing the main results of EMPATHY Part A to determine the next steps in the development program and a strategy for regulatory submissions to achieve expedited approvals. After reviewing the results, we plan to launch Part B of EMPATHY as soon as possible, with the lowest effective dose identified in Part A of 75 mg, ”said a spokesperson.
Novartis was not available for an interview at the time of publication.
The company joined the ensovibep program in October 2020, disbursing $ 22 million upfront and an additional $ 44 million for a portion of equity. In May, the company launched a Phase II / III trial, sponsored by Molecular Partners, to test the candidate in early-stage Covid patients. Now, Novartis is exercising its option to recoup the rights, which will cost it around an additional $ 162 million plus “significant royalties” on sales.
“These encouraging results come at a time when the need for therapies with panvariant activity, like ensovibep, has never been greater,” Amstutz said in a statement.
Navigation has not been smooth for ensovibep, which was excluded from the NIH ACTIV-3 study in November after failing a futility analysis in hospital patients with Covid-19.
The molecule comes from a class of drugs developed by Molecular Partners which aims to perform the same functions as antibodies with much greater target specificity and antiviral protection. Although the DARPin candidate appeared safe, it did not show efficacy on day 5, when a total of 470 patients were assessed for their need for supplemental oxygen, mechanical ventilation, or other supportive care. .
“It could very well be, it’s the optimistic part, that in the subgroups, there is something. But at the same time, it’s such a difficult and heterogeneous environment, that maybe futility was the right point to say, “Rethink, let’s look at the data,” Stumpp said.