Our Success
Our Success
The following case studies are testament to the successful partnerships with Momentum Clinical Research that have contributed to new innovative medicines and treatments going to market.
Large Scale Vaccine Recruitment Case Study
In 2024, Momentum Clinical Research was called upon to conduct a large-scale vaccine trial under uniquely challenging circumstances. The unprecedented stop/start/pause nature of this study involved multiple protocol amendments and shifting start dates. Once the final go-ahead arrived, we had just three weeks to re-engage participants with updated messaging and finish recruiting our target of 2,000 participants across 12 sites in New Zealand and Australia.
Despite the trial being closed after just six days, Momentum quickly made a significant contribution to recruitment.
Arexvy - RSV Vaccine, Older Adults.
Momentum Clinical Research enrolled 97 participants across 3 sites from 2021 - 2024 in a study that lead to the Arexvy vaccine being approved to market to protect older adults from RSV.
Clinical Research Papers published:
Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults, Papi A, Ison MG, Langley JM et al for the AReSVi-006 Study Group. N Engl J Med; 2023 Feb 16;388(7):595-608
https://pubmed.ncbi.nlm.nih.gov/36791160/
Study Aim:
Prior to this study, no vaccine was available for the prevention of RSV in older adults.
Results:
Prior to Arexvy, there was no vaccine available for the prevention of RSV in older adults. The vaccine efficacy against RSV-related lower respiratory tract disease was 82.6%; 94.1% against severe RSV-related lower respiratory tract disease and 71.7% against RSV-related acute respiratory infection [Papi et al 2023]
Mounjaro - For Type 2 Diabetes.
Momentum Clinical Research was the highest recruiting site in Australia with a study conducted in the midst of the Covid 19 pandemic from 2019- 2022. The study successfully lead to the Mounjaro medication going to market to improve HbA1c in people with type 2 diabetes.
Clinical Research Papers published:
Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Del Prato S, Kahn SE, Pavo I, et al on behalf of the SURPASS-4 Investigators. Lancet 2021 Nov 13 398(10313);1811-1824
Study Aim
GLP-1 and GIP are incretin hormones released from the gut that regulate insulin response to a meal. GLP-1 receptor agonists (eg Ozempic) are recommended by clinical practice guidelines for the treatment of type 2 diabetes and obesity, and to reduce cardiovascular risk in people with type 2 diabetes. Like GLP-1, GIP also promotes insulin secretion after a meal and reduces bodyweight by enhancing satiety. Unlike GLP-1, GIP exerts glucagonotropic effects and favourably effects lipid homoeostasis. These complimentary properties of GLP-1 and GIP stimulated the development of the dual GIP and GLP-1 receptor agonist tirzepatide (Mounjaro).
Results:
In people with type 2 diabetes and elevated cardiovascular risk, tirzepatide, compared with insulin glargine, demonstrated greater and clinically meaningful HbA1c reduction with a lower incidence of hypoglycaemia at week 52.
Nuvaxovid - Vaccine for Covid-19
Momentum randomised 88 participants onto a study from 2022-2023 that successfully led to the Nuvaxovid Covid-19 vaccine being developed.
Clinical Research Papers published:
Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial. Bennett C, Bloch M, Neville AM et al on behalf of the Novavax 2019nCoV-311 Study Group Lancet Infect Dis 2024;24: 581–93
Study Aim:
SARS-CoV-2 variants evade immunity despite vaccination with prototype COVID-19 vaccines or previous infection. The 2019nCoV-311 study evaluated immune responses after two booster doses of a vaccine containing the omicron BA.5 subvariant spike protein in adults previously vaccinated with a prototype (ie Wuhan or original Covid variant) mRNA vaccine (Pfizer or Moderna).
Results:
The study findings showed that the bivalent vaccine booster induced more robust immune responses than the prototype (Wuhan) booster against clinically relevant variants of interest. Boosting with the monovalent Omicron BA.5-containing vaccine alone resulted in the highest neutralising titres against omicron BA.5. This study supports the development of monovalent and/or bivalent vaccines for the most currently circulating variants, to optimise protection.
Repatha - for high LDL cholesterol
Momentum Clinical Research sites participated in a study that successfully led to the Repatha medication being developed to lower LDL cholesterol levels.
Clinical Research Papers published:
Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events. Sabatine MS, Giugliano RP, Wiviott SD et al for the OSLER) investigators. N Engl J Med 2015;372:1500-1509
Study Aim:
Reduction in low-density lipoprotein (LDL) cholesterol levels has proved to be highly effective in reducing rates of major cardiovascular events, so LDL cholesterol reduction has been incorporated into practice guidelines as a fundamental means of reducing cardiovascular morbidity and mortality. THis study looked a new class of molcule (a monoclonal antibody) that inhibit proprotein convertase subtilisin–kexin type 9 (PCSK9) has emerged that very effectively lower LDL. cholesterol levels.
Results:
Evolocumab, a fully human monoclonal antibody, typically achieved approximately a 60% reduction in LDL cholesterol levels when compared with conventional therapy alone. In addition, an exploratory analysis showed that a number of cardiovascular events, when combined in a composite of all cardiovascular events, those receiving the new treatment had a significantly lower rate of all cardiovascular events (about half) than did patients in the standard-therapy group.
Shingrix - Herpes zoster vaccine
Momentum Clinical Research sites were involved in a research study from 2019- 2022 that led to the development of Shingrix, a vaccine to help prevent the Herpes zoster virus.
Clinical Research Papers published:
Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. López-Fauqued M, Campora L, de Looze F, et al. Vaccine 37 (2019) 2482–2493
Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Oostvogels L, Cunningham AL, de Looze F, et al for the ZOE 50/70 study groups. Vaccine. 2019 Oct 8;37(43):6262-6267
Study Aim:
After chickenpox, the varicella-zoster virus (VZV) can remain in the central nerve roots for many years, and may later reactivate, resulting in herpes zoster (HZ), also known as shingles.
It affects approximately 1 in 3 individuals in their lifetime, and is associated with significant illness and impact on quality of life. Shingles can cause severe pain that can last for months.The most frequent complication of HZ is postherpetic neuralgia (PHN), occurring in up to 30% of patients.
Results:
The ZOE-50 and ZOE-70 phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Free Shingrix vaccination under the National Immunisation Program (NIP) in Australia is available for eligible people at moderate to high risk of severe illness and complications from shingles.
Trelegy Ellipta - Triple Therapy COPD Inhaler
Momentum Clinical Research sites participated in a research study between 2014 and 2016 that successfully led to the Trelegy Ellipta triple therapy inhaler being developed for people with COPD.
Clinical Research Papers published:
Triple inhaled therapy for chronic obstructive pulmonary disease. Montuschi P, Malerba M, Macis G, et al. Drug Discovery Today Volume 21, Issue 11, November 2016, Pages 1820-1827
Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. Lipson DA, Barnhart F, Brealey N et al for the IMPACT Investigators. N Engl J Med 2018;378:1671-1680
Study Aim:
Triple therapy in a single inhaler is a new therapeutic option for chronic obstructive pulmonary disease (COPD). Combining individual drugs in a single inhaler is the most convenient way to deliver triple therap - a long-acting muscarinic receptor antagonist (LAMA) added to an inhaled corticosteroid (ICS) and a long-acting β2-adrenoceptor agonist (LABA) fixed-dose combination (FDC) could improve efficacy of pharmacological treatment of patients with COPD.
Results:
Triple therapy with fluticasone furoate (ICS), umeclidinium, (LAMA) and vilanterol (LABA) resulted in a lower rate of moderate or severe COPD exacerbations than fluticasone furoate–vilanterol or umeclidinium–vilanterol in this population. Triple therapy also resulted in a lower rate of hospitalisation due to COPD than umeclidinium–vilanterol.
A 5-in-1 meningococcal ABCWY vaccine candidate (4CMenB) accepted for regulatory review by US FDA
Momentum Clinical Research randomised 82 participants onto the study between 2020 and 2023.
The study was conducted in the midst of the Covid 19 pandemic and was successful despite frequent and prolonged border closures, enforced periods of isolation of both participants and staff and limited participant numbers allowed on site. This 5-in-1 meningococcal ABCWY vaccine candidate (4CMenB) has been accepted for regulatory review by US FDA
Clinical Research Papers published:
Breadth of Immune Response, Immunogenicity, and Safety: Results from a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults. Nolan T, Bloch M, Tiong F et al on behalf of the QUINTET study group. Open Forum Infectious Diseases OUP 2024 Oct
Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. Nolan T, Santolaya ME, de Looze F, et al. Vaccine 37 (2019) 1209–1218
Study Aim:
In this study, the performance of 4CMenB was evaluated against a large number of N. meningitidis strains, based on the vaccine’s killing activity against diverse strains.
Results:
Results showed the breadth of immune response following administration of 4CMenB (two doses, two or six months apart) against the 110 serogroup B strains tested. The three-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0-2 schedule.
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