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Mereo BioPharma Group plc (NASDAQ: MREO) is a United Kingdom-based biopharmaceutical company dedicated to developing innovative therapeutics for rare and specialty diseases. The company's primary focus is on acquiring and advancing mid-stage development programs from larger pharmaceutical firms, aiming to transform patient quality of life and improve human health. Mereo's strategy includes optimizing the commercial value of its programs through strategic partnerships or, for select opportunities, by commercializing products independently.
Mereo has a robust pipeline of late-stage clinical product candidates, particularly in rare disease areas. The company's flagship candidates include setrusumab for Osteogenesis Imperfecta (OI) and alvelestat for severe Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD). Setrusumab, developed in partnership with Ultragenyx Pharmaceutical Inc., has shown promising results in reducing the annualized fracture rate by 67% in OI patients. The Phase 2/3 Orbit study continues to enroll patients, aiming for regulatory approvals from both the FDA and EMA.
Alvelestat, another key candidate, has demonstrated significant effects in clinical trials, including the ATALANTa study. The data supports its use for AATD-LD, and the company is aligning with both the FDA and EMA on Phase 3 study designs, targeting a broader patient population. Mereo is actively seeking partners for further development and commercialization of alvelestat.
Additionally, Mereo is advancing its oncology pipeline with candidates such as etigilimab (anti-TIGIT) and navicixizumab. Etigilimab is in a Phase 1b/2 trial for recurrent/advanced solid tumors, while navicixizumab has completed a Phase 1 study and is under a global licensing agreement with OncXerna Therapeutics Inc.
Financially, Mereo reported cash and short-term deposits of £51.2 million as of September 30, 2023, with a cash runway extending into 2026. The company has also recently entered into a global license agreement with ReproNovo SA for leflutrozole, a non-steroidal aromatase inhibitor.
Mereo BioPharma's commitment to rare disease therapeutics positions it as a significant player in the biopharmaceutical landscape, with ongoing advancements in its clinical programs and strategic partnerships shaping its path forward.
Mereo BioPharma Group (NASDAQ: MREO) announced that CEO Dr. Denise Scots-Knight will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 8:00 AM ET. The event will be accessible via a live audio webcast on Mereo's investor website, and an archived replay will be available for two weeks post-event. Mereo focuses on developing therapeutics for oncology and rare diseases, with several clinical-stage product candidates including etigilimab and navicixizumab, as well as rare disease treatments like alvelestat.
Mereo BioPharma announced encouraging results from its Phase 1b/2 trial of alvelestat in hospitalized COVID-19 patients. The trial showed that patients receiving alvelestat, alongside standard care, experienced a more rapid improvement in the WHO Disease Severity score compared to those on placebo. A total of 15 patients were involved, and no safety signals were reported, though headaches were noted more frequently in the alvelestat group. Results suggest that alvelestat could provide clinical benefits beyond standard COVID-19 treatments.
Mereo BioPharma presented initial data from a study of alvelestat at the 63rd American Society of Hematology Annual Meeting. The Phase 1b/2 trial involves patients with bronchiolitis obliterans syndrome (BOS) post-hematopoietic stem cell transplantation, showing that treatment with alvelestat was well-tolerated and led to a decrease in biomarkers related to elastase activity. Out of seven patients, six had stable or improved lung disease, with some demonstrating significant symptom improvement. The findings suggest alvelestat's potential to impact lung fibrosis in BOS.
Mereo BioPharma (NASDAQ: MREO) reported interim efficacy data from its ACTIVATE study of etigilimab, an anti-TIGIT antibody, in combination with nivolumab for advanced solid tumors. Among 15 patients evaluated, one complete response was observed in cervical cancer, one partial response in ovarian cancer, and four cases of stable disease. The study demonstrated a favorable safety profile, with no new safety signals. The trial aims to enroll around 125 patients. Further updates are anticipated in 2022.
Mereo BioPharma Group plc (NASDAQ: MREO) announced that CEO Dr. Denise Scots-Knight will present at two investor conferences. The Jefferies London Healthcare Conference features an in-person fireside chat on November 17 at 10:00 a.m. GMT. The Piper Sandler 33rd Annual Virtual Healthcare Conference will have an on-demand presentation available starting November 22 at 10:00 a.m. ET. Both sessions can be accessed via the Investors section of Mereo's website, with replays available for two weeks. Mereo focuses on oncology and rare diseases, with several clinical-stage product candidates.
Mereo BioPharma Group (NASDAQ: MREO) announced the upcoming presentation of data from a study on alvelestat for treating Bronchiolitis Obliterans Syndrome (BOS) at the ASH Annual Meeting from December 11-14, 2021. The study involved seven BOS patients post-hematopoietic stem cell transplantation, revealing that alvelestat consistently suppressed biomarkers of elastase activity and collagen turnover in six patients. This indicates a potential impact on progressive lung fibrosis. The poster presentation will happen on December 11, 2021, featuring results that highlight the drug’s therapeutic promise.
Mereo BioPharma Group plc (NASDAQ: MREO) announced that the FDA granted Orphan Drug Designation to alvelestat for treating alpha-1 antitrypsin deficiency (AATD). This designation highlights the urgent need for therapies addressing this rare, life-threatening condition. Alvelestat, currently in a Phase 2 clinical trial, aims to protect patients from lung damage caused by neutrophil elastase. The Orphan Drug Designation offers various incentives, including seven-year market exclusivity upon approval. Mereo plans to update its program by year-end 2021.
Mereo BioPharma (MREO) presented secondary endpoint data from the Phase 2b ASTEROID study for UX143 (setrusumab) at the ASBMR 2021 Annual Meeting. The study revealed a statistically significant bone-building effect in Osteogenesis Imperfecta (OI) patients, with an 8.97% increase in lumbar spine bone mineral density at 12 months in the highest dose cohort. Improvements in bone strength at the wrist and tibia were also observed. Following these results, Mereo BioPharma and Ultragenyx plan to advance UX143 into late-stage development for various OI subtypes.
Mereo BioPharma Group plc (NASDAQ: MREO) has appointed Pierre Jacquet, M.D., Ph.D. to its Board of Directors as of September 20, 2021. Dr. Jacquet brings over 20 years of experience in life sciences and strategy, previously serving as Managing Director at L.E.K. Consulting. His expertise is expected to enhance the company's clinical portfolio development. Concurrently, Peter Bains has retired from the Board after over six years of service. Mereo focuses on innovative therapies for oncology and rare diseases, with product candidates in various stages of clinical trials.
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