Concerns of lower-than-expected efficacy, which prompted AN2 Therapeutics Inc. to pause enrollment in the phase III portion of the phase II/III trial earlier this year, turned out to be well-founded, as top-line data proved disappointing for epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease. As a result, the company is dropping the program and restructuring.
Novartis AG CEO Vas Narasimhan during the company’s July 18 second-quarter earnings call said his firm was “still in the midst of completing” the buyout disclosed in February of Morphosys AG, of Munich, for €2.7 billion (then US$2.9 billion), which brought worldwide rights to pelabresib, the small-molecule BET inhibitor for myelofibrosis.
Aldeyra Therapeutics Inc. has bounced back from a complete response letter in November to produce positive phase III data for reproxalap in treating dry eye disease. The company is one of many developing treatments using diverse mechanisms of action.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients.
The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
Ondine Biomedical Inc.’s Steriwave light-activated antimicrobial technology will be used in a pilot program at Leeds Teaching Hospitals NHS Trust in the U.K. to help fight infections in patients undergoing skull base sinus surgery. The Steriwave technology offers a quick nasal decolonization treatment that reduces the need for antibiotics and the risk of postoperative infections.
Lest there’s any confusion, Lucid Diagnostics Inc. published promising results from a third study showing the benefit of its non-invasive Esoguard test for detecting esophageal cancer and precancer conditions.
Levicept Ltd. is scoping the options for phase III development after reporting positive results from its phase II trial of LEVI-04 in the treatment of pain caused by osteoarthritis of the knee. The full data are yet to be published, but the company said the potentially first-in-class neurotrophin-3 inhibitor demonstrated significant differences from placebo, with a mean reduction in pain score from baseline of more than 50%, for the three doses tested.
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