After posting positive top-line data in August from its phase III ENHANCE-2 study of ensifentrine for treating chronic obstructive pulmonary disease (COPD), Verona Pharma plc now has positive results from the companion phase III study. The ENHANCE-1 trial of ensifentrine as a COPD maintenance treatment hit its primary and key secondary endpoints, prompting the company to say it plans to submit an NDA for the treatment to the U.S. FDA sometime in the first half of 2023.
With its acquisition of Subintro Ltd., Rigimmune Inc. put a building block in place to further its development of stem-loop RNA therapeutics that selectively activate the innate immune sensor RIG-I. Subintro specializes in development and delivery of antiviral therapeutics for respiratory diseases caused by RNA viruses, including influenza, rhinovirus and SARS-CoV-2. Subintro’s technology allows the company to consider topical and nasal delivery.
U.K.-based seed investor Lifearc Ventures is celebrating a second major deal from its portfolio of companies after Abbvie Inc. bought the tiny former “garage startup" DJS Antibodies Ltd. for $255 million up front plus undisclosed milestone payments. DJS’ lead program is DJS-002, a potential first-in-class lysophosphatidic acid receptor 1 antagonist in preclinical studies for the treatment of idiopathic pulmonary fibrosis and other fibrotic diseases.
After a midstage trial showed no benefit from adding ELX-02 (exaluren) to Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) for certain cystic fibrosis (CF) patients, Eloxx Pharmaceuticals Inc. said it will discuss next steps for the program, its lead candidate, with the trial's sponsor, the CF Foundation. A proof-of-concept trial for EXL-02 in the rare kidney disease Alport syndrome will start later this year, the company said.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Lee’s Pharmaceutical (HK) Ltd. and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., expanded their rights to lucinactant Surfaxin, lyophilized lucinactant Surfaxin LS and Aerosurf from Windtree Therapeutics Inc. in a $78.9 million global license deal to develop and commercialize the candidates for the treatment of preterm infants with respiratory distress syndrome and other potential indications.
Top-line data from Verona Pharma plc’s phase III ENHANCE-2 study show its inhaled ensifentrine hit the primary and secondary endpoints in treating chronic obstructive pulmonary disease (COPD). Next up: data from the companion phase III, ENHANCE-1, which is expected by the end of 2022.
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.”
Genentech Inc. is paying Kiniksa Pharmaceuticals Ltd. $100 million in up-front and near-term payments for the development and commercialization rights to vixarelimab, a fully human monoclonal antibody. Kiniksa also could receive up to approximately $600 million in certain clinical, regulatory and sales-based milestones, as well as royalties on annual net sales.
A paper published March 22 in the journal Chest highlighted research that found patients with interstitial lung disease (ILD) who had poor quality of life specifically related to cough were more likely to be hospitalized for respiratory issues, need a lung transplant and die. The findings in 1,447 patients matter because they back previous investigations and provide a way of predicting the advance of ILD, of which idiopathic pulmonary fibrosis (IPF) is a prominent type. A handful of companies are working on drugs to tackle cough in IPF, often an early symptom of the disease.
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