Alvelestat

GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure

9 days ago

• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients. • The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments. • iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.

Mereo BioPharma's Setrusumab Shows Promise in Phase II, Alvelestat Gains EMA Orphan Status

4 months ago

• Phase II results for setrusumab demonstrated significant improvements in fracture rates and bone strength, supporting continued development despite initial Phase III interim analysis outcomes. • Mereo's alvelestat received EMA Orphan Designation, adding to its existing FDA Fast Track and Orphan Drug Designations, strengthening its regulatory position. • The company's robust financial position extends through 2027, providing stable support for ongoing clinical development programs and strategic partnerships.

Mereo BioPharma's Setrusumab Phase 3 Trial Progresses; Alvelestat Receives Positive EMA Opinion

6 months ago

• Mereo BioPharma's setrusumab Phase 3 Orbit study for osteogenesis imperfecta is ongoing, with a second interim analysis expected in mid-2025. • Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, received a positive EMA opinion on its European Orphan Designation application. • The European Commission is expected to make a final decision on Alvelestat's Orphan Designation in the first quarter of 2025. • Mereo BioPharma's current cash and cash equivalents are expected to fund operations into 2027, covering key milestones.

Setrusumab Receives FDA Breakthrough Therapy Designation for Osteogenesis Imperfecta

6 months ago

• The FDA granted Breakthrough Therapy Designation to setrusumab for reducing fracture risk in osteogenesis imperfecta (OI) types I, III, and IV, for patients aged 2 years and older. • The designation was based on positive Phase 2 Orbit study results, showing a clinically meaningful decrease in fracture rate in patients with OI. • Mereo BioPharma anticipates alvelestat will be Phase 3 ready around the end of 2024, remaining in discussions for potential partnerships for its development and commercialization for AATD lung disease. • Mereo BioPharma's cash reserves of $80.5 million as of September 30, 2024, are expected to fund operations into 2027, supporting clinical trials and pre-commercial activities.

Mereo BioPharma Advances Rare Disease Pipeline with Setrusumab and Alvelestat

a year ago

• Mereo BioPharma's partner, Ultragenyx, anticipates completing enrollment for the Phase 3 Orbit study of setrusumab in Osteogenesis Imperfecta (OI) by the end of Q1 2024. • A global Phase 3 study design for alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) has been aligned upon following interactions with the FDA. • Mereo BioPharma has signed a global licensing deal with ReproNovo SA for the development and commercialization of leflutrozole. • The company's current cash reserves are projected to sustain operations into 2026, supporting ongoing clinical trials and development programs.

Mereo BioPharma Announces Updated Operating Plan to Maximize Shareholder Value

3 years ago

Mereo BioPharma Group plc has announced an updated operating plan aimed at maximizing shareholder value by reducing headcount by 40% and significantly cutting expenses. The plan extends the company's cash runway into 2026 and focuses on advancing its core rare disease programs. Updates on lead programs include progress on setrusumab for Osteogenesis Imperfecta, alvelestat for Alpha-1 antitrypsin deficiency, and etigilimab in combination with nivolumab for cancer treatment.