$0.860
+0.100 (+11.66%)收盘时
MIRA 资讯
MIRA 事件
Mira Pharmaceuticals Completes Toxicology Studies for MIRA-55
Mira Pharmaceuticals announced results from completed seven-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs. MIRA-55 is the company's investigational oral, non-opioid drug candidate being developed for inflammatory pain. The completed studies characterized tolerability, toxicity, and systemic exposure across both species. Rats were identified as the more sensitive species, while dogs demonstrated greater tolerance across the dose levels studied. Toxicokinetic analyses confirmed systemic exposure in both species and characterized how exposure changed with dose and repeated administration. Importantly, the studies achieved their intended dose-range finding objective by generating the cross-species information needed to guide dose selection for the next phase of MIRA-55's ongoing IND-enabling program. The company plans to use these findings to inform the design of subsequent GLP-compliant toxicology studies.
Mira Pharmaceuticals Announces Positive Toxicokinetic Findings for SKNY-1
Mira Pharmaceuticals announced positive toxicokinetic findings from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. The study demonstrates dose-dependent systemic exposure and rapid absorption that de-risk dose selection and support advancement toward GLP toxicology studies and IND-enabling development. SKNY-1 demonstrated rapid oral absorption and dose-dependent systemic exposure across the evaluated dose range. Plasma concentrations were comparable between male and female animals. The data demonstrates evidence of dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection for the planned GLP toxicology program.
Mira Pharmaceuticals Advances MIRA-55 and SKNY-1 Development
Mira Pharmaceuticals announced continued advancement of its two preclinical programs, MIRA-55, an investigational oral non-opioid drug candidate for chronic inflammatory pain, and SKNY-1, an investigational oral drug candidate for obesity and addiction-related disorders. Over the past several weeks, the company has advanced both programs through multiple coordinated development activities, including formulation optimization, chemistry, manufacturing and controls activities, manufacturing development, and exploratory non-GLP toxicology and toxicokinetic studies. Collectively, these milestones support the continued progression of both programs toward the next phase of IND-enabling development. Following previously announced formulation optimization for both candidates, MIRA has continued advancing pharmaceutical development activities designed to support future nonclinical and regulatory development. Current CMC efforts include analytical, formulation, and manufacturing development activities intended to support future GLP-compliant toxicology studies and subsequent clinical development. In parallel, the company has completed the in-life dosing and scheduled necropsy phases of exploratory, non-GLP, 7-day repeated-dose toxicology and toxicokinetic studies evaluating MIRA-55 and SKNY-1 in both Sprague Dawley rats and Beagle dogs. These exploratory studies are designed to provide information regarding tolerability, systemic exposure and dose selection to help inform the design of future GLP-compliant IND-enabling toxicology studies. Sample analysis, toxicokinetic evaluation and histopathology remain ongoing.
MIRA Pharmaceuticals Optimizes Oral Drug MIRA-55
MIRA Pharmaceuticals announced results from preclinical studies evaluating optimized oral formulations of MIRA-55, the Company's oral drug candidate being developed as a non-opioid therapy for chronic inflammatory pain. Following evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration. Collectively, these findings support the continued development of MIRA-55 as an orally administered therapy for chronic inflammatory pain. The objective of the study was to optimize the oral formulation of MIRA-55 by comparing multiple formulations in a preclinical pharmacokinetic study. An intravenous reference arm was included to characterize absolute oral bioavailability and support selection of the lead formulation based on its overall pharmacokinetic profile. The selected formulation demonstrated reproducible distribution into both brain and liver tissue following oral administration. Brain exposure may support modulation of central pain-processing pathways, while peripheral distribution may contribute to the anti-inflammatory activity previously observed in MIRA's preclinical efficacy studies. Together, these findings demonstrate that the optimized formulation successfully delivers MIRA-55 to pharmacologically relevant tissues associated with both central and peripheral mechanisms of chronic inflammatory pain. The Company plans to continue evaluating the relationship between tissue exposure, pharmacodynamic activity, and therapeutic efficacy as MIRA-55 advances through additional preclinical development.
MIRA Pharmaceuticals Announces Preclinical Results for SKNY-1
MIRA Pharmaceuticals announced results from preclinical studies evaluating the optimized oral formulation of SKNY-1, the Company's oral drug candidate being developed for obesity and addiction-related disorders. The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial liver exposure following oral administration. Peak plasma concentrations were observed approximately six to twelve hours after dosing, supporting the potential for convenient once-daily oral dosing. Collectively, these findings further strengthen the development profile of SKNY-1 by demonstrating that the compound combines meaningful pharmacologic activity observed in previously reported efficacy studies with pharmacokinetic characteristics that support continued development as an orally administered therapeutic. The objective of the study was to optimize the oral formulation of SKNY-1 and evaluate its pharmacokinetic profile, oral bioavailability, and tissue distribution following oral administration. Multiple oral formulations were evaluated in a preclinical pharmacokinetic study to identify an optimized formulation that provides reproducible systemic exposure together with meaningful distribution into pharmacologically relevant target tissues. Importantly, SKNY-1 demonstrated robust brain penetration and substantial liver exposure following oral administration. Detectable tissue exposure was consistently observed across multiple animals, supporting reliable and reproducible distribution into target organs. The simultaneous exposure of both the central nervous system and liver is particularly significant because these organs regulate complementary aspects of appetite, reward signaling, and metabolic homeostasis. Brain penetration may support modulation of neuronal circuits involved in appetite, satiety, and reward-associated behaviors, while liver exposure may contribute to regulation of lipid metabolism, glucose homeostasis, and energy utilization previously observed in preclinical efficacy studies. Importantly, robust brain penetration was achieved while maintaining a differentiated central nervous system profile. As previously reported by the Company, SKNY-1 was devoid of anxiety-related behavior in a validated preclinical cannabinoid behavioral model despite engaging central cannabinoid pathways. These findings distinguish SKNY-1 from earlier CB1-targeting therapies, including rimonabant, which were associated with significant neuropsychiatric adverse effects.
本页仅供研究参考，不构成投资建议。模型可能出错。过往表现不代表未来结果。