Covid-19 is still a trending indication as per recently announced Phase III trials in infectious diseases. According to GlobalData’s Clinical Trial Database, six out of the 11 planned trials disclosed in the last two weeks will be investigating Covid-19 boosters and therapeutics. GlobalData is the parent company of Clinical Trials Arena. As for other indications, monkeypox, shingles, molluscum contagiosum, sepsis and gram-negative bacterial infections also appear in this recently announced Phase III trial pipeline.
mRNA boosters head-to-head
Everest Medicines is planning to investigate its PTX-COVID19-B as a booster shot with the trial starting in February 2023. The active-control study (NCT05534048) will recruit 3800 participants into efficacy and safety cohorts.
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The efficacy cohort will include patients who previously received two doses of Pfizer-BioNTech’s Comirnaty vaccine three months prior. All subjects will receive a dose of either Comirnaty or PTX-COVID19-B.
The safety cohort will have subjects who received any primary doses of vaccines approved by WHO Emergency Use Authorisation three months prior, or already received authorised booster jabs and planned to receive PTX-COVID19-B as their fourth shot. All participants in the safety cohort will receive one dose of the investigational booster.
The trial will be about six months long for each participant, with estimated end date in July 2023. PTXCOVID-19B is an mRNA vaccine. The primary endpoints will evaluate the non-inferiority to Comirnaty and assess the safety profile.
Fourth dose study
Murdoch Children’s Research Institute will be launching the fourth dose Covid-19 study next month. The Australian trial (NCT05543356) will evaluate the immunogenicity, safety and reactogenicity of a second standard monovalent or bivalent Omicron-specific (Pfizer-BioNTech or Moderna) Covid-19 booster.
The eight-arm study will recruit 800 subjects who received two primary doses of Pfizer-BioNTech Comirnaty and AstraZeneca’s Vaxzevria, and one Pfizer-BioNTech booster vaccines.
The primary outcomes will evaluate total incidence of systemic and local solicited reactions seven days after randomisation and SARS-CoV-2 specific immunoglobulin (Ig)G antibodies at 28 days. The estimated end date is December 2022, according to the ClinicalTrials.gov registry.
Oral antiviral in non-hospitalised patients
Atea Pharmaceuticals announced its plans to investigate bemnifosbuvir as both monotherapy and combination antiviral treatment for non-hospitalised Covid-19 patients who are at the highest risk of disease progression, regardless of vaccination status. The global trial is set to start in Q4 2022.
The randomised, placebo-controlled trial will recruit 1500 patients with mild or moderate Covid-19 infection. The study will evaluate 550mg of bemnifosbuvir twice-daily (BID) with locally available standard of care (SOC) and compare it to placebo BID with SOC for five days.
Depending on the SOC availability, two populations will be included in the trial. The “supportive care population”, when patients don’t quality for SOC or there isn’t one locally available, will evaluate the all-cause hospitalisation and death rate through 29 days as primary endpoint. The second group, “combination antiviral population”, will be included in the secondary endpoint measuring all Covid-19 complications, medically attended visits and symptom rebound.
Bemnifosbuvir targets the viral RNA polymerase, resulting in termination of RNA synthesis and inhibition of viral replication. This molecule was also investigated in a Phase II trial (NCT04019717) in patients with Hepatitis C infection as a combination treatment with Daklinza (daclatasvir).
TPOXX trial expands to Canada
Clinical Trials Arena previously reported on the global launch of multiple monkeypox vaccine and antiviral clinical trials. Now, the Canada-based McGill University Health Centre is joining the PLATINUM study investigating SIGA Technologies’ TPOKXX (tecovirimat) in the UK, led by Oxford University.
The placebo-controlled, pragmatic trial PLATINUM-CAN (NCT05534165) will evaluate the same dose regimen as in the UK study. 120 non-hospitalised patients with laboratory confirmed and presumptive infection will be dosed with 600mg of TPOXX BID. The trial is set to start this month and end in January 2023, according to ClinicalTrials.gov registry.
The primary endpoint will measure the time of active lesion resolution up to 28 days after randomisation. As a feasibility study, the Canadian trial is underpowered to fully evaluate the primary endpoint and the results will be combined with its sister UK trial.
TPOXX is an antiviral agent that blocks the ability the virus from spreading to other cells, preventing it from causing disease. It was marketed in 2018 for the treatment of smallpox.
Peptide as an add-on sepsis treatment
Gufic BioSciences will be investigating the combination of Thymosin alpha-1 (Ta1) and SOC. The placebo-controlled trial (CTRI/2022/09/045538) will recruit 120 patients diagnosed with sepsis but not in the immediate need for surgery.
Participants will receive either two subcutaneous injections of Ta1 with SOC or two subcutaneous injections of placebo with SOC for seven days. The primary endpoint will measure the change in sequential organ failure assessment (SOFA) score.
Thymosin alpha-1 is a naturally occurring peptide that acts as an immune modulator to restore a dysregulated immune response. The asset was also investigated in a placebo-controlled Phase III trial (CTRI/2020/10/028277) as a treatment for moderate to severe Covid-19 patients. The treatment arm had a statistically lower death rate (11.1%) compared to the placebo arm (38.5%).
Other planned Phase III infectious disease trials
Biotech Curevo hinted to the initiation of Phase III trials investigating CRV-101, a subunit vaccine, as a treatment for Herpes Zoster, also known as shingles, after announcing completed Phase IIb trial enrolment. The later Phase study is expected to start in the beginning of 2023.
University of Oklahoma will investigate topical benzoyl peroxide in the pediatric population with molluscum contagiosum, with the start date in February 2023. The open-label, active-control trial (NCT05536882) will recruit 150 children, aged 1-14, diagnosed with the viral infection who have not received prior treatment.
Brii Biosciences is turning to gram-negative infections with a trial that is expected to begin in H2 2023. The study will investigate the beta lactamase inhibitor BRII-636.
Another Covid-19 study (NCT05542862) with Vaxine testing its subunit recombinant spike protein vaccine Spikogen as a third or fourth booster dose. The estimated start date is this September. The single-arm trial will recruit 150 adults who received any of the primary course vaccine regimens.
ResBiotic will investigate the role of resB in protecting healthcare workers. The single-blind trial will recruit 820 vaccinated subject who will receive either two oral doses of the probiotic combination or vitamin C as placebo.
Finally, the Center for Studies in Pediatric Infectiology plans to recruit 100 adults to evaluate the safety and immunogenicity of an inactivated heterologous Covid-19 booster. The open-label trial (NCT05545683) is set to start in December 2022.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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