BioCryst resumes enrollment for immune diseases drug; Eagle buys stake in respiratory disease biotech

09 Aug 2022
endpts.com
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In April, the FDA hit BioCryst with a partial hold, leading the biotech to pause enrollment on three of its rare disease clinical trials and sending its shares down 30%. Last week, BioCryst said the partial clinical hold had been resolved and that it would resume enrolling its clinical trials for its drug, dubbed BCX9930, but with new protocols at a lower 400 mg dose. BioCryst’s drug is a factor D inhibitor, which was being tested in an array of immune diseases. The biotech is running two pivotal trials for paroxysmal nocturnal hemoglobinuria, as well as a third trial looking at a set of three diseases — C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy. The Durham, NC-based biotech initially paused enrollment after finding increased creatine levels in patients that had received the 500 mg dose of its drug. Elevated creatine levels are a sign of potential kidney damage. Months after it dropped $100 million to buy up Acacia and its two drugs, Eagle Pharmaceuticals is back at it with a smaller $25 million investment in Enalare Therapeutics. The specialty pharma player will pay $12.5 million upfront, followed by an additional $12.5 million in six months. Eagle is eyeing Enalare’s lead candidate, ENA-001, a big potassium (BK) channel inhibitorpotassium (BK) channel inhibitor that is meant to stimulate breathing. The first indication in which the biotech is testing the drug is post-operative respiratory depression. According to the press release , the drug should enter a Phase II trial early next year. If the drug enters said Phase II trial and reaches 50% enrollment in that trial, Eagle has the option to make two additional investments of $15 million each, and it also has the option to acquire the biotech entirely. In HealthCare Royalty Partners’ latest deal , the investment firm will loan up to $65 million to Clearside Biomedical. Clearside will get $32.5 million initially, followed by $12.5 million if the biotech reaches certain sales milestones for its microinjection macular edema drug Xipere, which the FDA approved in 2021. In 2024, if Clearside meets additional sales milestones, HealthCare Royalty Partners will loan an additional $20 million. Clearside’s main product is its microinjection technology for delivering eye therapies. Bausch + Lomb licensed Xipere from Clearside, and has exclusive rights to develop and commercialize the drug in the US and Canada. Clearside is also working on an injectible TKI inhibitor to potentially treat wet AMD, diabetic macular edema and diabetic retinopathy. That candidate, dubbed CLS-AX, is excluded from the HealthCare Royalty Partners deal.
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