MREO: US$3.20 MPH: 59.00GBp

A diversified portfolio

Late stage clinical stage products in bone, respiratory, endocrine and oncology diseases

Our mission is to provide new therapies to patients with chronically debilitating and life limiting diseases that have few, if any, other treatment options. We are working collaboratively with regulators and healthcare authorities to find the best, most effective pathways forward, so that our therapies are developed and available as quickly as possible without compromising safety.

Mereo’s pipeline consists of a diversified portfolio of six clinical-stage product candidates; BPS-804 (setrusumab) for the treatment of osteogenesis imperfecta (“OI”), MPH-966 (alvelestat) for the treatment of severe alpha-1 antitrypsin deficiency (“AATD”), BCT-197 (acumapimod) for the treatment of acute exacerbations of chronic obstructive pulmonary disease (“AECOPD”), BGS-649 (leflutrozole) for the treatment of hypogonadotropic hypogonadism (“HH”) in obese men, OMP-305B83 (navicixizumab) for the treatment of platinum-resistant ovarian cancer, and OMP-313M32 (etigilimab) for patients with advanced or metastatic solid tumors.

We are focused on developing and commercializing rare disease therapies in the areas of bone/musculoskeletal, respiratory and endocrinological diseases. We intend to seek strategic relationships for further clinical development and commercialization of our specialty disease and oncology therapies.

RARE DISEASE PRODUCTS

Drug/disease
Phase 1 Phase 2A Phase 2B Pivotal
BPS-804 (setrusumab) Osteogenesis Imperfecta
Pediatric
Adult
Pivotal Registration Study
Phase 2b (ASTEROID) Fully Enrolled

BPS-804 (setrusumab) is a fully human monoclonal antibody designed to inhibit sclerostin, thereby improving bone strength and therefore reduce fractures in patients with osteogenesis imperfecta (OI) and improve quality of life.

OI is a rare genetic disorder, commonly known as brittle bone disease, which is characterized by fragile bones that fracture easily. In addition to fractures, individuals with OI often have muscle weakness, hearing loss, fatigue, joint laxity, curved bones, scoliosis, and short stature. The majority of cases of OI (up to 90 %) are caused by a dominant mutation in the genes coding for type I collagen, a key component of healthy bone. Current treatment of OI is based on supportive care, focusing on treating fractures and maximizing mobility. To date, there are no FDA or EMA approved treatments.

Click here for more information.

MPH-966 (alvelestat) Alpha-1 Antitrypsin Deficiency
Phase 2 Currently Enrolling

MPH-966 (alvelestat) is an oral neutrophil elastase inhibitor being explored for the potential treatment of alpha-1 antitrypsin deficiency (AATD). AATD is a rare, genetic disease that results in a deficiency of alpha-1 antitrypsin. The loss of the normally protective effect of alpha-1 antitrypsin against damaging enzymes, specifically neutrophil elastase, released during inflammation, leads to lung damage because of the irreversible destruction of the lungs’ supportive elastic tissues.

AATD can, as a result, cause pulmonary emphysema, a life-threatening lung disease, resulting in severe shortness of breath, wheezing, chronic cough and sputum production, as well as recurring chest colds, pneumonia, year-round allergies and bronchiectasis – permanent enlargement of parts of the lungs airways. People with Alpha-1 lung disease very often need to progress to oxygen use to perform normal daily tasks, significantly impacting quality of life from an early age. People with Alpha-1 liver disease may experience jaundice, swelling of the abdomen as the liver damage progresses due to the build-up of abnormal alpha-1 antitrypsin enzyme in the liver. People might also experience panniculitis, a painful swelling of the panniculus, the layer of tissue under the skin.

Click here for more information.

Phase 1 Phase 2A Phase 2B Pivotal
BPS-804 (setrusumab) Osteogenesis Imperfecta
Pediatric
Pivotal Registration Study
Adult
Phase 2b (ASTEROID) Fully Enrolled

BPS-804 (setrusumab) is a fully human monoclonal antibody designed to inhibit sclerostin, thereby improving bone strength and therefore reduce fractures in patients with osteogenesis imperfecta (OI) and improve quality of life.

OI is a rare genetic disorder, commonly known as brittle bone disease, which is characterized by fragile bones that fracture easily. In addition to fractures, individuals with OI often have muscle weakness, hearing loss, fatigue, joint laxity, curved bones, scoliosis, and short stature. The majority of cases of OI (up to 90 %) are caused by a dominant mutation in the genes coding for type I collagen, a key component of healthy bone. Current treatment of OI is based on supportive care, focusing on treating fractures and maximizing mobility. To date, there are no FDA or EMA approved treatments.

Click here for more information.

MPH-966 (alvelestat) Alpha-1 Antitrypsin Deficiency
Phase 2 Currently Enrolling

MPH-966 (alvelestat) is an oral neutrophil elastase inhibitor being explored for the potential treatment of alpha-1 antitrypsin deficiency (AATD). AATD is a rare, genetic disease that results in a deficiency of alpha-1 antitrypsin. The loss of the normally protective effect of alpha-1 antitrypsin against damaging enzymes, specifically neutrophil elastase, released during inflammation, leads to lung damage because of the irreversible destruction of the lungs’ supportive elastic tissues.

AATD can, as a result, cause pulmonary emphysema, a life-threatening lung disease, resulting in severe shortness of breath, wheezing, chronic cough and sputum production, as well as recurring chest colds, pneumonia, year-round allergies and bronchiectasis – permanent enlargement of parts of the lungs airways. People with Alpha-1 lung disease very often need to progress to oxygen use to perform normal daily tasks, significantly impacting quality of life from an early age. People with Alpha-1 liver disease may experience jaundice, swelling of the abdomen as the liver damage progresses due to the build-up of abnormal alpha-1 antitrypsin enzyme in the liver. People might also experience panniculitis, a painful swelling of the panniculus, the layer of tissue under the skin.

Click here for more information.

NON-RARE DISEASE PRODUCTS

Drug/disease
Phase 1A Phase 1B Phase 2A Phase 2B Phase 3
BCT-197 (acumapimod) Acute Exacerbations of COPD
Phase 3-ready

BCT-197 (acumapimod) is an oral p38 MAP kinase inhibitor that has completed Phase 2 development as first-line therapy for severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Acumapimod is given during a severe exacerbation to reduce the risk of further exacerbations.

AECOPD is characterized by a sudden worsening in the COPD patient’s symptoms of dyspnoea, cough and sputum production. These episodes typically last for several days and often require hospitalization of the patient and an increase in medication. Severe exacerbations are where the patient is hospitalised or visits the emergency room. The number of acute exacerbations a patient experiences on an annual basis is directly related to mortality. AECOPDs occur in the natural course of the disease but are commonly triggered by infections and air pollution. BCT-197 aims to address the airway and systemic inflammation that are characteristic drivers of the disease and to reduce the frequency of subsequent severe AECOPDs.

Click here for more information.

BGS-649 (leflutrozole) Hypogonadotropic Hypogonadism in Obese Men
Phase 2b & Safety Extension Complete

BGS-649 (leflutrozole) is a novel once weekly oral aromatase inhibitor that has completed Phase 2b development as a first-line therapy for the treatment of obese men with hypogonadotropic hypogonadism (HH).

HH is a clinical syndrome that results from inadequate levels of testosterone. Symptoms that are most commonly associated with testosterone deficiency include reduced or loss of libido, the absence of morning erections and erectile dysfunction. Other common symptoms include fatigue, impaired physical endurance, loss of vitality, lack of motivation and mood disturbance. In the obese, the decrease in testosterone is driven by high levels of the aromatase enzyme in fat tissue which irreversibly converts testosterone into estradiol. BGS-649 normalizes testosterone levels by inhibiting aromatase and is therefore expected to improve the related conditions.

Click here for more information.

OMP-305B83 (navicixizumab) Ovarian Cancer
Phase 1b Fully Enrolled

We are currently completing a Phase 1b clinical trial with OMP-305B83 (navicixizumab) in combination with paclitaxel in patients with heavily pre-treated platinum-resistant ovarian cancer. Ovarian cancer remains a deadly malignancy because most patients develop recurrent disease that is resistant to chemotherapy, including platinum.

OMP-305B83 (navicixizumab) is an anti-DLL4/VEGF bispecific antibody targeting both DLL4 in the Notch cancer stem cell pathway and vascular endothelial growth factor (VEGF). This antibody is expected to have anti-angiogenic plus anti-cancer stem cell activity. In a Phase 1a clinical trial in 66 patients, OMP-305B83 (navicixizumab) demonstrated single-agent anti-tumor activity and was safe enough to be administered on a continuous basis.

Click here for more information.

OMP-313M32 (etigilimab) Solid Tumours
Phase 1a Fully enrolled

We are currently completing a Phase 1a/b clinical trial in patients with advanced or metastatic solid tumors. The Phase 1a portion investigated single agent activity with the Phase 1b in combination with nivolumab. Etigilimab is an anti-TIGIT therapeutic candidate designed to activate the immune system through multiple mechanisms and enable anti-tumor activity. TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is an inhibitory receptor that is thought to prevent T-cells from attacking tumor cells, similar to the inhibitory protein PD-1.

Click here for more information.

Phase 1A Phase 1B Phase 2A Phase 2B Phase 3
BCT-197 (acumapimod) Acute Exacerbations of COPD
Phase 3-ready

BCT-197 (acumapimod) is an oral p38 MAP kinase inhibitor that has completed Phase 2 development as first-line therapy for severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Acumapimod is given during a severe exacerbation to reduce the risk of further exacerbations.

AECOPD is characterized by a sudden worsening in the COPD patient’s symptoms of dyspnoea, cough and sputum production. These episodes typically last for several days and often require hospitalization of the patient and an increase in medication. Severe exacerbations are where the patient is hospitalised or visits the emergency room. The number of acute exacerbations a patient experiences on an annual basis is directly related to mortality. AECOPDs occur in the natural course of the disease but are commonly triggered by infections and air pollution. BCT-197 aims to address the airway and systemic inflammation that are characteristic drivers of the disease and to reduce the frequency of subsequent severe AECOPDs.

Click here for more information.

BGS-649 (leflutrozole) Hypogonadotropic Hypogonadism in Obese Men
Phase 2b & Safety Extension Complete

BGS-649 (leflutrozole) is a novel once weekly oral aromatase inhibitor that has completed Phase 2b development as a first-line therapy for the treatment of obese men with hypogonadotropic hypogonadism (HH).

HH is a clinical syndrome that results from inadequate levels of testosterone. Symptoms that are most commonly associated with testosterone deficiency include reduced or loss of libido, the absence of morning erections and erectile dysfunction. Other common symptoms include fatigue, impaired physical endurance, loss of vitality, lack of motivation and mood disturbance. In the obese, the decrease in testosterone is driven by high levels of the aromatase enzyme in fat tissue which irreversibly converts testosterone into estradiol. BGS-649 normalizes testosterone levels by inhibiting aromatase and is therefore expected to improve the related conditions.

Click here for more information.

OMP-305B83 (navicixizumab) Ovarian Cancer
Phase 1b Fully Enrolled

We are currently completing a Phase 1b clinical trial with OMP-305B83 (navicixizumab) in combination with paclitaxel in patients with heavily pre-treated platinum-resistant ovarian cancer. Ovarian cancer remains a deadly malignancy because most patients develop recurrent disease that is resistant to chemotherapy, including platinum.

OMP-305B83 (navicixizumab) is an anti-DLL4/VEGF bispecific antibody targeting both DLL4 in the Notch cancer stem cell pathway and vascular endothelial growth factor (VEGF). This antibody is expected to have anti-angiogenic plus anti-cancer stem cell activity. In a Phase 1a clinical trial in 66 patients, OMP-305B83 (navicixizumab) demonstrated single-agent anti-tumor activity and was safe enough to be administered on a continuous basis.

Click here for more information.

OMP-313M32 (etigilimab) Solid Tumours
Phase 1a Fully enrolled

We are currently completing a Phase 1a/b clinical trial in patients with advanced or metastatic solid tumors. The Phase 1a portion investigated single agent activity with the Phase 1b in combination with nivolumab. Etigilimab is an anti-TIGIT therapeutic candidate designed to activate the immune system through multiple mechanisms and enable anti-tumor activity. TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is an inhibitory receptor that is thought to prevent T-cells from attacking tumor cells, similar to the inhibitory protein PD-1.

Click here for more information.