HomeMost PopularInvestingBayer's Groundbreaking Elinzanetant Secures Success in Third Phase III Study

Bayer’s Groundbreaking Elinzanetant Secures Success in Third Phase III Study

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A New Dawn for Bayer’s Elinzanetant

Bayer AG BAYRY reported favorable top-line outcomes from the phase III trial, OASIS 3, evaluating the efficacy and safety of elinzanetant, a promising pipeline candidate, in comparison to a placebo.

Elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, is currently in advanced clinical stages for the non-hormonal management of moderate to severe vasomotor symptoms (VMS) linked to menopause, administered orally once a day.

The Triumph of OASIS 3

OASIS 3 stands as the third phase III trial in the OASIS clinical program. The trial enlisted 628 postmenopausal women aged between 40 and 65 from 83 research sites in nine nations.

Results revealed that elinzanetant effectively achieved the primary goal, displaying a significant reduction in the frequency of moderate to severe VMS (commonly known as hot flashes) from baseline to week 12 in comparison to the placebo group.

This study’s results provide valuable supporting data on the efficacy and long-term safety of elinzanetant, building on the positive outcomes from OASIS 1 and 2.

In January, Bayer disclosed the top-line data from the initial two phase III trials, OASIS 1 and 2 (NCT05042362 and NCT05099159), which successfully met all primary and key secondary endpoints.

Bayer plans to submit data from OASIS 1, 2, and 3 to regulatory bodies for the approval of marketing authorizations for elinzanetant in addressing moderate to severe VMS associated with menopause.

Diversifying the Horizon: OASIS 4 and Beyond

The late-stage clinical development endeavor for elinzanetant, OASIS, currently encompasses four phase III trials β€” OASIS 1, 2, 3, and 4.

Bayer Aktiengesellschaft Price, Consensus and EPS Surprise

Bayer Aktiengesellschaft Price, Consensus and EPS Surprise

Bayer Aktiengesellschaft price-consensus-eps-surprise-chart | Bayer Aktiengesellschaft Quote

OASIS 4 expands the phase III initiative, exploring the effectiveness and safety of elinzanetant in women experiencing moderate to severe VMS due to endocrine therapy for treating or preventing breast cancer.

The phase III program stemmed from encouraging results in two phase II trials β€” RELENT-1 and SWITCH-1.

With its pivotal position in Bayer’s pipeline, the successful progression and commercialization of elinzanetant are crucial for Bayer, especially in light of recent adversities.

Beyond Challenges: A Vision for Growth

As Bayer navigates challenges, including recent regulatory and pipeline setbacks, the company looks to enhance its portfolio. The acquisition of KaNDy Therapeutics Ltd. in 2020 paved the way for Bayer to integrate elinzanetant into its pipeline.

Despite a 54.9% decline in BAYRY shares over the past year, compared to the industry’s growth of 30.1%, Bayer remains resolute in its pursuit of growth and innovation.

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The brave journey includes the exploratory phase II study, NIRVANA, assessing elinzanetant’s efficacy and safety in women facing sleep disturbances due to menopause.

Amidst these efforts, Bayer recently secured exclusive marketing rights for the cardiovascular candidate, acoramidis, in Europe from BridgeBio.

Adversity: Navigating Setbacks and Seizing Opportunities

Bayer faced challenges such as the early termination of the late-stage study, OCEANIC-AF, due to lack of efficacy in asundexian compared to Eliquis in patients with atrial fibrillation at risk for stroke, marking a significant setback for the company.

Additionally, competition against Xarelto, one of Bayer’s top drugs, intensifies due to generic alternatives entering the market.

The ongoing glyphosate litigation in the United States has strained Bayer’s financial position with mounting legal costs, prompting a review of capital allocation priorities and a revised dividend policy.

Despite these challenges, Bayer remains steadfast in its ambition to expand its offerings and drive innovation amidst adversity to shape a brighter future.

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