Authors: Siobhan Bennett, Future Science Group
Take a look at this month’s industry headlines including an FDA approval for Zebraxa, new funding for chikungunya vaccine clinical trials and falling shares for hepatitis vaccine Sci-B-Vac.
- FDA announce approval of Zebraxa® for hospital-acquired ventilator-associated bacterial pneumonia
- Themis Bioscience receives funding for Phase III trials of chikungunya vaccine
- New trial of antibiotic iclapram 10 years after first FDA rejection
- Shares fall for VBI’s experimental hepatitis B vaccine Sci-B-Vac despite hitting main goals
FDA announce approval of Zebraxa® for hospital-acquired ventilator-associated bacterial pneumonia
The US FDA have announced the approval of Merck and co’s (NJ, USA) antibiotic Zebraxa in patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) aged 18 years and older. Zebrxa was FDA approved in 2014 for treatment of intra-abdominal infections and complicated urinary tract infections, thus this was a supplemental New Drug Application for the drug.
The approval was based on the multinational, double-blind Phase III ASPECT-NP study, in which a total of 726 adults hospitalized with HABP/VABP and all on mechanical ventilation were enrolled comparing intravenous Zebraxa every 8 hours to meropenem for 8–14 days, demonstrating non-inferiority.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” explained Amy Abernethy (FDA Principal Deputy Commissioner), “HABP/VABP are serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”
Themis Bioscience receives funding for Phase III trials of chikungunya vaccine
Themis Bioscience (Venice, Austria) is to receive €18.7 million in order to finance the first chikungunya vaccine trials for its vaccine MV-CHIK. While development of an effective vaccine for chikungunya has been in the works for 50 years, there is no effective vaccine to-date.
The money provided will cover the cost for a Phase III MV-CHIK clinical trial and assist with developing other vaccines, including those for Zika and cancer. The funding comes from the Coalition for Epidemic Preparedness Innovations (CEPI) where the public and private organizations work in alliance to speed up the development of vaccine infections causing humanitarian crises.
Themis has strong background for vaccine development as the CEPI also provided them with €33 million last year to fuel the development of vaccines against Lassa fever and MERS. Themis’ MV-CHIK vaccine showed promise in preventing chikungunya last year, producing strong immune responses in 263 volunteers in a Phase II trial. The vaccine is now being fast-tracked by both the FDA and the EMA.
New trial of antibiotic iclapram 10 years after first FDA rejection
In 2009 the FDA rejected the antibiotic iclapram as the treatment was unsafe to use and the efficacy case was deemed to be unconvincing. Despite this, Motif Bio plc (London, UK) have resubmitted the antibiotic originally developed by Arpida (Reinach, Switzerland).
Researchers have demonstrated that the antibiotic hit the primary endpoint for in a successful non-inferiority Phase III clinical trial. The study, involving 600 patients, was a double-blind comparative test of iclopram and vanomycin to treat acute bacterial skin and skin structure infections. The team tracked a 78% clinical cure rate among patients treated with iclapram compared with 77.7% in vanomycin-treated patients. While this seems a promising new start for the drug, the FDA are concerned abut the potential for liver toxicity and therefore are requesting another clinical trial to clear up these concerns.
Graham Lumsden (Motif Bio plc) stated they’ll now be going back to the FDA to define the size of the trial needed, so they can go about budgeting for it. The controversy of such antibiotic has however caused a 90% decline in share value over the past few months and the company will now have to raise the money to cover the next trial.
Shares fall for VBI’s experimental hepatitis B vaccine Sci-B-Vac despite hitting main goals
VBI Vaccines (MA, USA) recently announced a Phase III study of its experimental hepatitis B vaccine, Sci-B-Vac, had met both of its co-primary endpoints. Despite this success, the secondary goal was missed, decreasing the company’s shares by as much as 62%. This is a setback for the vaccine’s development in a highly competitive field.
The PROTECT study enrolled 1607 adults and compared the seroprotection rate (SPR) of the Sci-B-Vac vaccine and the already approved GlaxoSmithKline’s (Brentford, UK) Engerix-B. The participants were treated with either 10mcg of Sci-B-Vac or 20mcg of Enegerix-B, demonstrating a superiority where Sci-B-Vac had a SPR of 89.4% and Engerix-B had a SPR of 73.1%. The top-line data further indicted that the SPR of Sci-B-Vac was significantly higher in all key subgroups after 3 weeks of vaccination.
Despite this initial success the trial failed to meet the secondary goal of non-inferiority between multiple doses of the vaccines. The study showed that two doses of the Sci-B-Vac wasn’t as effective as three doses of Engerix -B and this sent VBI vaccine’s shares plummeting. This vaccine has already been approved in Israel and 10 other countries. Jeff Baxter (VBI Vaccines) explained: “We remain on track to submit applications for regulatory approvals in the US, Europe, and Canada beginning mid-year 2020.”
Missed last month’s headlines? Catch up now: