Dupixent (dupilumab) continues to expand its scope, this time potentially leading it and its developers into a new, multibillion dollar blockbuster market. Dupixent hit the primary and all key secondary endpoints in a phase III study of treating chronic obstructive pulmonary disease (COPD).
Mereo Biopharma Group plc said its path to approval for alvelestat is a phase III study that would preclude an additional confirmatory trial. After meetings with the U.S. FDA and the EMA to discuss next steps, Mereo said it is designing a single, 12- to 18-month, global phase III of the neutrophil elastase inhibitor for treating alpha-1-antitrypsin deficiency-associated lung disease.
Tetra Bio-Pharma Inc. has received clearance from Health Canada to proceed with a first-in-human trial in Canada using oral ARDS-003 (onternabez) to treat various immunomodulatory conditions. Oral ARDS-003 is positioned to modulate acute systemic inflammation and prevent sepsis, acute respiratory distress syndrome (ARDS) and organ damage.
Chiesi Farmaceutici SpA has agreed to pay Affibody AB up to $214 million in a collaboration and licensing agreement to develop an inhaled treatment for respiratory diseases, with a further $423 million also in the cards if the deal is extended to two more programs. The fees consist of up front and milestone payments, based on certain development, regulatory and commercial achievements, with additional mid-single to low double-digit royalties on sales.
Obesity is tied to airway hyperresponsiveness and lung fibrosis, which may lead to patients with asthma and obesity poorly responding to asthma therapy. Blocking proprotein convertase subtilisin/kexin type 9 (PCSK9) is known to reduce serum cholesterol levels and to exert anti-inflammatory effects.
A new study found that nebulized mRNA therapy could be an effective approach to treating acute respiratory distress syndrome (ARDS), a rapidly progressing lung disease that can lead to respiratory failure and death. This work focused on two genes, nuclear factor kappaB (NF-κB) inhibitor α super-repressor (IκBα-SR) and superoxide dismutase 3 (SOD3), previously shown to reduce the severity of pneumonia when delivered prophylactically by viral vectors.
Antibody specialist Jounce Therapeutics Inc. and Redx Pharma plc are to merge in an all-share transaction with a value of $425 million, in a deal that will see Redx’s small-molecule cancer and fibrosis drugs absorbing the lion’s share of the combined cash and its shareholders owning 63% of the combined company.
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