Buloxibutid

Plus, news about IN8bio, Sanofi, Vicore Pharma, Cartherics, Zephyrm Bioscience, Tharimmune and Intract Pharma: Biohaven’s $250M offering: The move comes after Biohaven announced Monday that it started a pivotal Phase 2 study of its oral TRPM3 antagonist for migraines. The company also expects to grant the underwriters another $37.5 million of common shares. — Katherine Lewin Activist firm grows stake in Galapagos: EcoR1 crossed the 10% ownership threshold tied to voting securities, according to a disclosure on Monday . EcoR1 believes the Dutch biotech is “deeply undervalued” and previously said it would speak to the board and management about a “variety of topics” including board composition. — Max Bayer IN8bio’s $12.4M raise: The New York gamma-delta T cell therapy biotech priced the private placement a few weeks after announcing plans to prioritize its pipeline and halve its workforce. — Kyle LaHucik Sanofi invests $10M in Vicore Pharma: The Stockholm-based company is beginning a Phase 2b trial investigating its drug, buloxibutid, in patients with idiopathic pulmonary fibrosis who are either untreated or receiving the current standard of care. — Katherine Lewin Cartherics raises about $10 million: The money is set to go toward a clinical trial next year for the Melbourne-based company’s preclinical lead cell therapy for ovarian cancer, dubbed CTH-401. According to Cartherics, CTH-401 is the only natural killer cell therapy currently under development that includes a CAR that targets the adenocarcinoma specific antigen called TAG-72. — Katherine Lewin Zephyrm Bioscience files for IPO in Hong Kong: The seven-year-old startup wants to go public on the Hong Kong Stock Exchange to fund its pipeline of pluripotent stem cell therapies. Its lead therapy is expected to enter Phase 3 next year for two indications: acute exacerbation of interstitial lung disease, and acute graft versus host disease. — Kyle LaHucik Tharimmune, Intract Pharma to merge: The clinical-stage I&I biotech wants to combine with Intract, which makes a delivery system for oral biologics. The merger is slated to close in the first quarter of 2025, and Intract shareholders will own 49% of the combined company. — Kyle LaHucik

Boehringer’s nerandomilast is a preferential inhibitor of phosphodiesterase 4B (PDE4B). Image credit: Tada Images / Shutterstock. Boehringer Ingelheim is seeking regulatory approval for nerandomilast after a Phase III trial in idiopathic pulmonary fibrosis (IPF) met its primary endpoint. Boehringer confirmed the Phase III FIBRONEER-IPF trial (NCT05321069) met its primary endpoint of improving the forced vital capacity, a measure of lung function after 52 weeks. The company plans to present full efficacy and safety data from the study in the first half of 2025. Boehringer was quick to tout that nerandomilast’s Phase III trial was the first IPF late-stage trial in a decade to meet its primary endpoint. This is not the first time Boehringer has found success in the space. Its tyrosine kinase inhibitor (TKI) Ofev (nintedanib) was approved by the US Food and Drug Administration (FDA) to treat IPF in 2014. It has since been approved in the US for interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD) and chronic interstitial lung disease. Ofev has also raked in record profits for Boehringer , last year the therapy generated €3.5bn ($3.89bn) in global sales. The Phase III FIBRONEER-IPF trial enrolled 1,177 patients with IPF randomised to receive either nerandomilast or placebo twice daily. The study’s secondary endpoint is time to the first occurrence of acute IPF exacerbation, first hospitalisation for respiratory cause, or death. See Also: Bicara Therapeutics closes $362m IPO in flurry of biotech listing activity MaxCyte and Kamau Therapeutics sign platform license agreement Nerandomilast is a preferential inhibitor of phosphodiesterase 4B (PDE4B). It received a breakthrough therapy designation from the US FDA for the treatment of IPF in 2022. Boehringer is also investigating nerandomilast in patients with progressive fibrosing interstitial lung diseases in a Phase III FIBRONEER-ILD trial (NCT05321082), which is due for completion by the end of the year. IPF has a high unmet need as there are only two US FDA-approved medications, Ofev and Roche’s Esbriet (pirfenidone). Whilst Roche’s TGF-beta synthesis inhibitor also secured FDA approval in 2014, it has seen its profits erode due to the introduction of generics . The drug earned SFr718m ($752m) in sales in 2022, which dropped to CHF202m ($239m) in sales last year, as per Roche’s financials. The majority of other therapies in development for IPF are in Phase II clinical trials. In May, Vicore Pharma’s Phase IIa trial of angiotensin II type 2 receptor (AT2R) agonist buloxibutid in IPF met both its primary and secondary endpoints. Bridge Biotherapeutics’ Phase II trial evaluating its autotoxin inhibitor , BBT-877 in IPF is expected to report topline data in the first half of 2025.