Irlab Therapeutics AB has obtained clearance from the Swedish Medical Products Agency to initiate a phase I study of IRL-757, which is being developed as a treatment to counteract apathy in Parkinson’s disease and other neurological conditions.
Philadelphia-based Latus Bio Inc., co-founded by serial biotech entrepreneurs P. Peter Ghoroghchian and Beverly Davidson, launched on May 2 with two lead adeno-associated virus (AAV)-based gene therapy candidates and $54 million in a series A financing.
Shares of Aeon Biopharma Inc. (NYSE:AEON) closed May 3 down $1.66, or 49%, finishing at $1.70 on word that the planned interim analysis of phase II data with ABP-450 (prabotulinumtoxinA) for preventing chronic migraine showed that the compound did not meet the primary endpoint. The Irvine, Calif.-based firm said it has “immediately commenced cash preservation measures and will review all strategic options.”
Latus Bio Inc. has launched with a focus on developing novel gene therapy candidates for central nervous system (CNS) disorders. An initial close of $54 million in series A financing will support the company.
While Nrx Pharmaceuticals Inc.’s oral antidepressant NRX-101 failed, producing a not statistically significant 33% reduction in suicidality along with a 70% reduction in the symptoms of akathisia, the company said it plans to forge ahead and conduct a registrational study.
Medtronic plc said it secured U.S. FDA approval for its first closed-loop spinal cord stimulator (SCS), designed to take in signals from the body and adjust its therapy automatically.
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
A readout of phase III data of buntanetap in Parkinson’s disease is up next as Annovis Bio Inc. tries to recover from the market’s reaction to mixed phase II/III results in Alzheimer’s disease. The company’s stock (NYSE:ANVS) dropped 60% when the data were released on April 29 and continued downward on April 30, with shares closing 23.5% lower at $5.57 each. The shares’ 12-month peak was on Dec. 27 at $19.54 each.
Newron Pharmaceuticals SpA added heft to the data supporting evenamide, reporting positive top-line results from a phase II/III placebo-controlled trial of the glutamate inhibitor in patients with chronic schizophrenia who were receiving a second-generation antipsychotic, but having an inadequate response to that treatment.