An autoimmune disease drug achieved positive results in a pivotal study, putting it on the path to regulatory submission. But not all drug developers were so lucky this week. Four companies are restructuring after disappointing clinical trial data. It’s been a busy week for data readouts and regulatory developments. Here’s a review of some of the highlights.
On the way to the FDA
— Pfizer reports that its experimental autoimmune drug, etramod, achieve primary and secondary goals A pivotal study in ulcerative colitis showed reductions according to a scale that assesses disease severity. Pfizer said it plans to present the full results at a future scientific meeting, and the data will be part of a planned submission to regulators.Drugs are the key Pfizer bought Arena Pharmaceuticals for $6.7 billion last year.
–last year end, Argenx Receives FDA Regulatory Recognition for efgartigimod, making infusion therapy the first approved treatment for the rare neuromuscular disease myasthenia gravis.The Netherlands-based biotech company now has Phase 3 preliminary data The drug formulation for subcutaneous administration was shown to be comparable to the formulation for infusion. With these results, Argenx said it is preparing a subcutaneous version of the Biologics License Application, which it plans to submit to the FDA by the end of 2022.
The numbers are disappointing
— Aligos Therapeutics stop working He worked on an experimental antisense oligonucleotide drug after participants in a chronic hepatitis B clinical trial developed the liver enzyme — a sign of drug-induced liver toxicity. The South San Francisco-based company said it will shift resources to small-molecule drugs, including candidates for chronic hepatitis B and nonalcoholic steatohepatitis.
— The ADHD drug Adderall is often misused and abused. Vallon Pharmaceuticals’ attempt to develop an abuse-suppressing, immediate-release formulation of dextroamphetamine, Adderall’s active ingredient, has run into setbacks: The drug Failure A key test to measure its abuse potential. Philadelphia-based Vallon said it will further analyze other study endpoints before determining next steps.
– Oerlik Pharmaceuticals is stop working In its lead program ORIC-101, an interim analysis of two Phase 1b studies showed insufficient clinical activity in various types of solid tumors. The South San Francisco-based biotech said it will shift its focus to three Phase 1 programs: ORIC-533 in multiple myeloma; ORIC-114 in cancers with EGFR/HER2 signatures; and ORIC-944 in prostate cancer. Initial data from all three projects is expected to be released in the first half of next year.
—Neurana Pharmaceuticals, San Diego report Its drug tolperisone fell short of the primary and secondary goals of a phase 3 study evaluating the experimental therapy as a way to relieve muscle spasms associated with painful musculoskeletal disorders. Given the failed clinical trial, Neurana said it has cut staff and reduced spending and is exploring strategic alternatives. If not confirmed, the biotech company said it would begin dissolving the company.
reject…
– FDA be rejected Eli Lilly seeks approval for sintilimab in non-squamous non-small cell lung cancer. The antibody, a type of cancer immunotherapy called a PD-1 inhibitor, is approved in China and marketed by China-based Innovent Biopharmaceuticals. Lilly submitted its FDA application based on clinical studies completed entirely in China.
According to Eli Lilly, the FDA’s full response letter asked the company to conduct an additional multiregional clinical study comparing sintilimab with the standard of care for first-line metastatic non-small cell lung cancer.The agency’s conclusions are consistent with those of the FDA Advisory Committee, which vote Additional clinical studies were recommended last month to evaluate the drug’s compatibility with the U.S. population and U.S. medical practice.
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