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Glaxo's (GSK) RSV Vaccine for Pregnant Women Enters Phase III

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GlaxoSmithKline plc (GSK - Free Report) has initiated patient dosing in a phase III study — GRACE — that will evaluate its maternal respiratory syncytial virus (RSV) vaccine candidate.

The late-stage study will evaluate the efficacy of a single dose of the unadjuvanted candidate, administered to pregnant women aged 18-49 years, in preventing medically assessed RSV-associated lower respiratory tract illnesses (LRTIs) in their new-born infants. The study will also evaluate the safety of the candidate in vaccinated mother as well as their new born infants. Interim results from the study are expected in the second half of 2020 and it is expected to be completed in 2024.

Glaxo has completed a phase I/II study on the candidate. The candidate has demonstrated promising safety and immunogenicity per the data presented from the study last month at the ID Week Congress. The candidate increased RSV-A and RSV-B neutralizing antibodies titers by 14-fold in pregnant mothers at day 8 following vaccination.

Please note that Glaxo is also developing RSV vaccines for pediatric as well as older adults using different novel technologies. The company’s RSV vaccine for older adults uses its proprietary AS01 adjuvant system. Data from the same phase I/II study demonstrated that the adjuvanted vaccine candidate achieved a close to 10 times increase of protective antibodies in the vaccinated patients. A phase III program for the RSV vaccine for older adults is anticipated to start within a few months. A phase I/II study evaluating pediatric RSV vaccine candidate is ongoing.

All three RSV vaccine candidates — pediatric, maternal and older adults — enjoy fast track designation in the United States.

Per the press release, an estimated 33 million annual cases of RSV occur in children below 5 years of age, globally. Moreover, there are no approved RSV vaccine so far. Glaxo’s RSV vaccine candidates also hold significant potential following their successful development.

So far this year, Glaxo’s shares have declined 21.8% compared with the industry’s 0.2% decrease.

Glaxo has a strong portfolio of marketed vaccines for meningitis, influenza, shingles and others generating billions of dollars in sales every year. Currently, Glaxo is competing with other pharma bigwigs and biotech companies in the race to bring a safe coronavirus vaccine. Glaxo and Sanofi (SNY - Free Report) have collaborated to develop a vaccine for COVID-19 using their innovative technologies. The companies aim to start a phase III study by year-end. We note that Pfizer (PFE - Free Report) and its partner BioNTech are leading the vaccine race as they have submitted regulatory application to the FDA for emergency use authorization for their coronavirus vaccine candidate.

Meanwhile, Glaxo has also collaborated with Vir Biotechnology (VIR - Free Report) to develop an antibody treatment for COVID-19 patients.

Zacks Rank

Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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