Shares in Regeneron Pharmaceuticals are advancing 4.4% in Wednesday’s pre-market trading after the company disclosed that its investigational two-antibody cocktail, REGN-COV2, lowered viral levels and improved symptoms in non-hospitalized Covid-19 patients.
Regeneron (REGN) said that the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its REGN-COV2 also showed positive trends in reducing medical visits. The ongoing, randomized, double-blind trial is testing the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care. This trial is part of a larger program that also includes studies of REGN-COV2 for the treatment of hospitalized patients, and for prevention of infection in people who have been exposed to COVID-19 patients.
The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, diminishing the ability of mutant viruses to escape treatment and protects against spike variants in the human population.
“The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response,” said Regeneron Chief Scientific Officer George D. Yancopoulos. “These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms. We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials.”
The descriptive analysis included the first 275 patients enrolled in the trial and was designed to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment. The next cohort used to confirm these results has already been enrolled, Regeneron said. Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo. All patients entering the trial had laboratory-confirmed COVID-19 that was being treated in the outpatient setting.
Until now, more than 2,000 people have been enrolled across the overall REGN-COV2 development program, and no unexpected safety findings have been reported. In addition to this trial in non-hospitalized patients, REGN-COV2 is currently being studied in a Phase 2/3 clinical trial for the treatment of COVID-19 in hospitalized patients, the Phase 3 open-label trial of hospitalized patients in the UK and a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. Recruitment in all 4 trials is ongoing.
Shares in Regeneron have soared over 53% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. That’s alongside an average analyst price target of $660.92 indicating upside potential of 15% from current levels.
J.P. Morgan analyst Cory Kasimov said that based on Tuesday’s dataset, Regeneron is in discussions with regulators on the potential for an emergency use authorization (EUA).
Kasimov reiterated a Hold rating on the stock, saying that although he is encouraged by Regeneron’s COVID-19 antibody cocktail, there remains a host of unanswered questions on the treatment as well as the commercial opportunity. (See Regeneron stock analysis on TipRanks).
“The results showed an impact on viral load in seronegative patients and a modest trend in reducing clinical outcomes in a subset of patients, but these data are by no means definitive,” Kasimov wrote in a note to investors. “The possibility that a diagnostic test may be required to identify amenable patients could also complicate things.”
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