Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Mereo Announces Successful End of Phase 2 Meeting with FDA and Provides Outline of Pivotal Trial Design for Acumapimod for Severe Exacerbations of COPD
London, 15 April 2019 - Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based, biopharmaceutical company focused on rare diseases, announces that it has held a successful Type B end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding acumapimod (BCT-197) as a treatment for the reduction of acute exacerbations of COPD (AECOPD).
In the meeting, Mereo and the FDA discussed, and agreed in principle, an outline for the design of a pivotal Phase 3 clinical trial programme to support the development of acumapimod as a five day treatment regimen for patients undergoing severe exacerbations of COPD to reduce further exacerbations. In summary, the programme consists of two randomised, double blind, placebo controlled studies comparing one dosing regimen of study drug on top of standard of care (SOC) to placebo plus SOC. The trials are expected to enrol approximately 800 patients each. The primary end point will be the time to next severe exacerbation/rate of severe exacerbations. Secondary endpoints will likely include the rate of moderate/severe exacerbations, reduction in systemic corticosteroid exposure, all-cause hospitalisation, lung function, symptoms measured by St Georges Health Questionnaire (SGHQ), safety and tolerability, including the option for re-treatment of severe exacerbations at any point after a 14 day period following initial dosing with follow-up to 12 months. Mereo will now work with the FDA to finalize the pivotal Phase 3 study design.
In line with Mereo's previously stated strategy, the Company commenced discussions with potential partners for acumapimod in 2018, which continue to progress.
Dr. Alastair MacKinnon, Chief Medical Officer said:
"We are pleased with this positive outcome from our meeting with the FDA, where we agreed, in principle, the design of the pivotal trial programme for acumapimod. This is a novel approach to treating the disease as patients are dosed during an acute exacerbation in order to reduce further exacerbations of COPD. This builds directly on the positive data we generated in our successful Phase 2 trial. We have previously stated our intention to partner acumapimod and believe that the outcome of this meeting will help us to progress these discussions."
Acumapimod is a p38 MAP kinase inhibitor in development as a therapy taken by patients with an AECOPD, in order to prevent or reduce the number of further exacerbations. It is designed to inhibit the pathological mechanism behind inflammation, which is a key feature of AECOPD. The Company believes acumapimod, if approved, offers a potential new treatment by targeting the underlying disease and delivering tangible benefits for patients and payers by potentially preventing AECOPD, and reducing readmissions.
The Company believes acumapimod has the following key advantages over current therapies:
- Potential to be a rapid-onset treatment targeting inflammatory drivers of AECOPD
- Designed to target anti-inflammatory response systemically and locally with easier and more flexible oral administration than inhaled treatments
- Simple oral regimen of three doses over five days that can be conveniently administered in an outpatient setting
- Designed to target pathophysiology of acute exacerbations without generalized immune suppression
- Potential for efficacy in steroid-resistant population
- A short course treatment that can prevent further exacerbations of COPD
Mereo is a biopharmaceutical company focused on the development and commercialisation of innovative therapeutics that aim to improve outcomes for patients with rare diseases. Mereo's strategy is to selectively acquire product candidates that have already received significant investment from pharmaceutical companies and that have substantial preclinical, clinical and manufacturing data packages. Each of Mereo's four product candidates has previously generated positive clinical data for Mereo's target indication or in a related indication. Since inception Mereo has commenced large, randomised, placebo-controlled Phase 2 clinical trials for all four of the product candidates:
BPS-804 for osteogenesis imperfecta (OI). The Company recently announced completion of enrolment with 112 adult patients in a Phase 2b dose ranging study with some initial data expected in Q2 2019 and top-line dose ranging data in late 2019. A pediatric Phase 3 study design has also been approved by the EMA. BPS-804 has orphan designation in the US and EU and has been accepted into the PRIME and Adaptive Pathways in EU;
MPH-966 for alpha-1 antitrypsin deficiency (AATD). The Company recently announced first patient in a Phase 2 dose ranging study in the US with data expected in late 2019;
BCT-197 (acumapimod) for acute exacerbations of COPD (AECOPD). The Company announced positive Phase 2 data in May 2018; and
BGS-649 for hypogonadotropic hypogonadism (HH). The Company announced positive top-line Phase 2b data in March 2018 and positive results from the Phase 2b safety extension study in December 2018.
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