acumapimod (BCT-197) / Novartis, Mereo Biopharma - LARVOL DELTA

Acumapimod Significantly Reduces Key Inflammatory Biomarkers in Severe COPD Exacerbations and Reduces the Rate of Re-Hospitalization (ATS 2025) - P2 | "Acumapimod at a dose of 75mg/40mg/40mg showed significant reductions in hsCRP and fibrinogen in AECOPD. More effective control of inflammation during an exacerbation may reduce treatment failure and exacerbation recurrence. Acumapimod has been shown to significantly reduce the rate of subsequent severe AECOPD; confirmatory studies are planned to substantiate these effects in this area of significant unmet need."

Biomarker • Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CRP

"@VasNarasimhan @AstraZeneca @VertexPharma @GSK @Amgen @LillyPad @MereoBioPharma $MREO non core asset Acumapimod BCT197 p38 licensed from @Novartis !Huge Opportunities Oral P38 MAP space $MREO $1 acumapimod $FULC $8 Losmapimod main asset $ACRS $14 https://t.co/SC60aZEeRK" (@ej23ny)

"It’s possible. Licensed from @Novartis Setrusumab, acumapimod, leflutrozole" (@ej23ny)

Mereo BioPharma Reports Full Year 2020 Financial Results and Recent Highlights (GlobeNewswire) - "Full year 2020 research and development expenses were £16.3 million, compared to £23.6 million in 2019....There were no ongoing studies for acumapimod in 2020 and this resulted in a decrease in R&D expenses for acumapimod of £0.3 million, or 72%."

Commercial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

A Physiologically Based Pharmacokinetic Model to Predict Potential Drug-Drug Interactions and Inform Dosing of Acumapimod, an Oral p38 MAPK Inhibitor. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Safety profiles were similar when acumapimod was co-administered with azithromycin or itraconazole. These studies highlight the value of PBPK modeling in drug development, and its potential to inform DDI investigations."

Journal • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Mereo BioPharma Announces Interim Financial Results for the Six Months Ended June 30, 2020 and Provides Corporate Update (GlobeNewswire) - "Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Discussions continuing on separate financing for the Phase 3 study agreed with the FDA and EMA."

Financing • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Phase II Study of Single/Repeated Doses of Acumapimod (BCT197) to Treat Acute Exacerbations of COPD. (PubMed, COPD) - P2 | "In this Phase II, double-blind, randomized, placebo-controlled dose-exploration study of acumapimod in patients with moderate or severe AECOPD (NCT01332097), patients presenting with AECOPD were randomized to receive single-dose acumapimod (20 mg or 75 mg) on Day 1, repeated single-dose acumapimod (20 mg or 75 mg) on Days 1 and 6, oral prednisone 40 mg (10 days), or placebo. In conclusion, repeated single-dose acumapimod showed a clinically relevant improvement in FEV over placebo at Day 8, along with consistent numerical differences in EXACT-PRO. These data can be used to determine dose regimens for a proof-of-clinical-concept trial."

Journal • P2 data • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases