相关临床试验
12
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2019
已完成
6
50.0%
招募中
4
33.3%
撤回
2
16.7%
暂无批准数据
- Alto Neuroscience reported a second-quarter 2026 net loss of $27.6 million and added a Phase 3 monotherapy trial of ALTO-207 in treatment-resistant depression (TRD). - An independent Nature Medicine publication of the PRIME-PRAXOL trial showed pramipexole significantly reduced anhedonia versus placebo (SHAPS mean difference −4.04; p=0.006). - A July 2026 offering raised approximately $100 million in gross proceeds, bringing pro forma cash to roughly $338 million and extending runway through 2030. - The expanded PACE program now spans three trials, with Phase 2b topline data expected in 2H 2027 and Phase 3 trials planned for early and 2H 2027.
- The FNIH announced the launch of MAP-D, a long-term study aiming to identify biomarkers for depression and define biologically distinct subtypes, moving beyond symptom-based diagnosis. - The initiative targets over $70 million in total funding, beginning with a $22 million, three-year pilot phase that will enroll more than 300 patients nationwide. - MAP-D will integrate genomics, neuroimaging, digital assessments, and patient-reported outcomes, using custom AI models to link biomarkers to patient outcomes over time. - The study is supported by a broad coalition including AbbVie, Eli Lilly, Alto Neuroscience, NAMI, and academic experts from Harvard, Stanford, Cornell, and Columbia.
- Alto Neuroscience received US Patent 12,521,374 for ALTO-207, a novel combination therapy of pramipexole and ondansetron for treatment-resistant depression. - The patent specifically protects the use of ondansetron to mitigate pramipexole side effects, enabling higher therapeutic doses needed for antidepressant benefits. - ALTO-207 demonstrated significant improvements on MADRS scores compared to placebo in a Phase 2a trial with 32 depression patients. - The company's intellectual property portfolio for ALTO-207 now provides protection extending into the mid-2040s, strengthening long-term commercial prospects.
- Alto Neuroscience's ALTO-101 received FDA Fast Track designation for treating cognitive impairment associated with schizophrenia, addressing a significant unmet medical need with no currently approved treatments. - The investigational phosphodiesterase-4 inhibitor demonstrated procognitive effects in Phase 1 testing, showing improvements in EEG measures and cognitive performance in healthy volunteers. - ANRO stock surged 10% in premarket trading following the announcement, with analysts maintaining strong buy ratings and price targets suggesting substantial upside potential. - The company is currently enrolling patients in a Phase 2 proof-of-concept study while utilizing its Precision Psychiatry Platform to identify patients most likely to respond to treatment.
- Alto Neuroscience shareholders filed a class action lawsuit in Northern California federal court, alleging the company misled investors about ALTO-100's clinical prospects and biomarker-driven efficacy for major depressive disorder. - ALTO-100 failed its Phase 2b trial on October 22, 2024, showing no significant difference from placebo on the primary endpoint, contradicting the company's positioning of the drug as a precision psychiatry breakthrough. - Following the trial failure disclosure, ANRO stock crashed 69.99% on October 23, 2024, wiping out most of the value from the company's $119.6 million IPO completed just months earlier. - The lawsuit claims Alto concealed key clinical limitations and overstated commercialization timelines while rushing its IPO to capitalize on inflated investor expectations.
- Relmada Therapeutics has officially halted development of esmethadone, an investigational NMDA receptor blocker for major depressive disorder, following three consecutive Phase III trial failures. - The company terminated its January 2018 licensing agreement for the drug after the RELIANCE III, RELIANCE I, and RELIANCE II trials all failed to demonstrate significant efficacy versus placebo. - Relmada is now shifting focus to strategic product acquisitions, with primary emphasis on NDV-01, a Phase II sustained-release formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. - The decision reflects broader challenges in depression drug development, with multiple biotechnology companies experiencing recent setbacks in this therapeutic area.
• Alto Neuroscience's ALTO-300, a novel biomarker-based antidepressant, advances in Phase 2b trial for Major Depressive Disorder with topline results expected by mid-2026. • The company's robust pipeline includes ALTO-203 for anhedonia, ALTO-101 for cognitive impairment in schizophrenia, and ALTO-100 for bipolar depression, with multiple data readouts expected in 2025-2026. • Previous open-label Phase 2a data demonstrated ALTO-300's superior efficacy in biomarker-positive patients, showing a 17-point MADRS improvement compared to 12.3 points in biomarker-negative patients.
- Alto Neuroscience reports positive interim results from its Phase 2b trial of ALTO-300 as an adjunctive treatment for major depressive disorder (MDD). - The trial uses an EEG biomarker to identify patients likely to respond, with plans to enroll 200 biomarker-positive subjects for final analysis. - ALTO-300, an oral 5-HT2C antagonist and melatonin agonist, is being tested alongside existing antidepressants in patients with inadequate response. - The study's primary endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline, with topline data expected mid-2026.
• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms in Phase II trials, a setback for the muscarinic pathway approach. • Bristol Myers Squibb's Cobenfy (KarXT), a muscarinic agonist, now stands as the frontrunner in schizophrenia treatment after AbbVie's trial failures. • Neurocrine Biosciences is advancing NBI-1117568, an oral muscarinic M4 selective agonist, with Phase III trials planned for early 2025, showing a potential path forward. • Other companies like Neumora Therapeutics and Reviva Pharmaceuticals are also exploring novel mechanisms for schizophrenia treatment, indicating a dynamic therapeutic landscape.
• Investment in neuroscience is increasing, driven by emerging treatments and unmet needs in CNS disorders, despite high risks and failure rates. • A major challenge is the high cost and poor translation of animal models in Phase III trials, making patient selection and biomarker identification crucial. • Advances in technology, such as AI and blood-based diagnostics, are improving early patient identification and streamlining clinical trial processes. • The potential of psychedelics for treating PTSD, depression, and anxiety is growing, but requires large-scale, robust trials due to a lack of biomarkers.
