Date: 2017-11-13
Type of information: Granting of a Fast Track status
Product name: BPS-804 - human monoclonal antibody targeting human sclerostin
Compound: human monoclonal antibody targeting human sclerostin
Therapeutic area: Rare diseases - Genetic diseases - Bone diseases
Action mechanism:
- monoclonal antibody. BPS-804 is a fully human monoclonal antibody that works by inhibiting sclerostin, which inhibits the activity of osteoblasts. Mereo believes that by blocking sclerostin, BPS-804 will induce or increase osteoblast function and maturation of these cells, increasing bone formation and reducing bone resorption, thereby reducing fractures in osteogenesis imperfecta patients. BPS-804 could potentially be a first-in-class therapy for use in this condition. Phase 2 proof of concept data in osteogenesis imperfecta patients demonstrated a statistically significant improvement in bone biomarkers and bone mineral density.
Company: Mereo BioPharma (UK)
Disease: osteogenesis imperfecta
Latest news:
- • On November 13, 2017, Mereo BioPharma announced that the European Medicines Agency (EMA) has granted BPS-804 PRIority MEdicines (PRIME) designation for the treatment of osteogenesis imperfecta. Mereo announced commencement of a Phase 2b trial for BPS-804 in adult patients with osteogenesis imperfecta in May 2017.
- The EMA PRIME programme provides early collaborative input to clinical development including scientific advice and health-technology-assessment in order to facilitate rapid access for patients to novel drugs in areas of high unmet medical need once they are approved. Under the PRIME programme, a marketing authorisation application (MAA) in Europe for BPS-804 for osteogenesis imperfecta could be eligible for an accelerated regulatory assessment (150 days instead of 210 days).
- As previously announced, BPS-804 for osteogenesis imperfecta has also been accepted into the EMA’s Adaptive Pathways Programme and has been granted orphan drug status in both the US and EU.
• On February 20, 2017, Mereo BioPharma announced that BPS-804 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways programme.
BPS-804 is being developed for the treatment of osteogenesis imperfecta (OI) (brittle bone disease). Mereo is on track to initiate a phase 2b trial for BPS-804 in H1 2017.
- • On May 17-19, 2016, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin for designation as an orphan medicinal product for the treatment of osteogenesis imperfecta. Mereo BioPharma intends to initiate a potential registration trial of BPS-804 in the second half of 2016. Phase 2 proof of concept data in osteogenesis imperfecta patients demonstrated a statistically significant improvement in bone biomarkers and bone mineral density.
- • On February 29, 2016, the FDA has granted BPS-804, a human monoclonal antibody targeting human sclerostin, orphan drug designation for the treatment of osteogenesis imperfecta, a rare, chronic genetic disorder that results in bones that can break easily.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2016-02-29
Orphan status UE: 2016-06-02
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
