BG00011 / Biogen - LARVOL DELTA

A Phase IIb Randomized Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis. (PubMed, Am J Respir Crit Care Med) - P2 | "The results do not support the continued clinical development of BG00011. Further research is warranted to identify new treatment strategies that modify inflammatory and fibrotic pathways in IPF Clinical trial registration available at www."

Clinical • Journal • P2b data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Mitigation of harmful algal blooms caused by Alexandrium catenella and reduction in saxitoxin accumulation in bivalves using cultivable seaweeds. (PubMed, Harmful Algae) - "In a toxin accumulation experiment, S. latissima significantly lessened (p<0.05) saxitoxin (STX) accumulation in blue mussels (Mytilus edulis), keeping levels (71.80±1.98 µg STX 100 g) below US closure limits (80 µg STX 100 g) compared to the untreated control (93.47±8.11 µg STX 100 g)...catenella activity were allelopathic, while nutrient competition, pH elevation, and macroalgae-attached bacteria may have played a contributory role in some experiments. Collectively, these results suggest that the integration of macroalgae with shellfish-centric aquaculture establishments should be considered as a non-invasive, environmentally friendly, and potentially profit-generating measure to mitigate A. catenella-caused damage to the shellfish aquaculture industry."

Journal

"More #IPF drug news. Ganesh Raghu reports BG-00011 (STX-100) blocks phosphorylation of Smad2 in BAL cells. Biology works. Now Hoping for clinical efficacy! @Simmons_ILD @KaminskiMed @IPFdoc @Eickelberg_MD" (@DKNYPitt)

Clinical • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

Biogen Idec increases revenue 18% to $1.4 billion in the second quarter (Biogen) - P2a, N=32; NCT01371305; Last week, the first patient was enrolled in a Phase 2a study for STX-100 in IPF

Enrollment status • Fibrosis

Imaging of Pulmonary Fibrosis with an ImmunoPET Probe Targeting the αvβ6 Integrin - "...The anti-αvβ6 blocking mAb 3G9 has been shown to reduce TGF-β activity and limit lung fibrosis in mouse models, and a humanized anti-αvβ6 mAb (STX-100/BG00011) is currently being evaluated in an IPF clinical trial... A 89Zr-labeled F(ab’)2 fragment binding αvβ6 can be used to image αvβ6 expression in vivo in a murine model of pulmonary fibrosis using PET."

Biosimilar • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology

SPIRIT: An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2; N=109; Terminated; Sponsor: Biogen; Active, not recruiting ➔ Terminated; Study was stopped because of safety concerns.

Clinical • Trial termination

"Oh, oh. Higher dose: Higher price. That'll make up for aducanumab, elenbecestat and BG00011. Not." (@PredatorDiaries)

SPIRIT: An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2; N=109; Active, not recruiting; Sponsor: Biogen; Recruiting ➔ Active, not recruiting; N=290 ➔ 109; Trial completion date: Nov 2021 ➔ Nov 2019; Trial primary completion date: Nov 2021 ➔ Nov 2019

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Biogen axes phase 2 study of lung-scarring med due to 'safety concerns' (FierceBiotech) - " 'Study was stopped because of safety concerns. End-of-study and safety follow-up visits are in progress,' read an update posted to the study on ClinicalTrials.gov. Biogen confirmed the study’s halt to RBC Capital Markets analysts, who flagged it Monday afternoon."

Trial termination

Evaluation of HRCT-Derived Quantitative Lung Fibrosis (QLF) Scores in an 8-Week Phase 2a Study for Treatment of Idiopathic Pulmonary Fibrosis (IPF) Using BG00011 (ATS 2019) - "The magnitude of association between QLF and FVC observed in this study are consistent with those reported in the literature1,2. The preliminary trend towards improvement in QLF scores through the 1mg/ kg dose along with the dose-dependent pSMAD suppression in BAL cells suggest that restoration of TGF-β homeostasis in IPF subjects may potentially impact fibrosis."

P2a data