D3 receptor

GOTHENBURG, SE / ACCESSWIRE / March 19, 2024 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, 19 March 2024 - IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson's disease, today announced that a scientific paper reporting the effects of IRLAB's candidate drug mesdopetam in a preclinical model of Parkinson's disease psychosis (PD-P) has been published in the journal Neurotherapeutics. The paper reports a series of preclinical studies performed by the group for Integrative Neurophysiology, Lund University, Sweden, in collaboration with scientists at IRLAB. The studies are based on characterization of the neurophysiological brain state in an advanced preclinical model of PD-P. The effects of Mesdopetam, along with two compounds, clozapine and pimavanserin, which are clinically used to alleviate PD-P, and an experimental D3 antagonist, were investigated in this model. The studies concluded that mesdopetam displays key features associated with antipsychotic efficacy in this PD-P model and should be further explored as a potential novel treatment option for psychosis in Parkinson's disease. "The brain state characterization presented in the paper is an impressive new technique which enables a new level of understanding of the brain mechanisms underlying PD-P and provides a great tool for evaluation of potential new therapies. These new results strongly support that mesdopetam has potential as a novel therapeutic in PD-P, also in light of the excellent safety and tolerability pro in clinical studies with mesdopetam," says Nicholas Waters, EVP & Head of R&D at IRLAB. For more information Nicholas Waters, EVP and Head of R&D Phone: +46 730 75 77 01 E-mail: nicholas.waters@irlab.se About the scientific paper on mesdopetam Title: Neurophysiological treatment effects of mesdopetam, pimavanserin and clozapine in a rodent model of Parkinson's disease psychosis, Neurotherapeutics, 2024, e00334. DOI: . Authors: Tiberiu Loredan Stan, Abdolaziz Ronaghi, Sebastian A. Barrientos, Pär Halje, Luciano Censoni, Emilio Garro-Martínez, Azat Nasretdinov, Evgenya Malinina, Stephan Hjorth, Peder Svensson, Susanna Waters, Kristoffer Sahlholm, Per Petersson. The studies revealed that the three compounds could reverse important features associated with the psychosis like state: Reduction of aberrant high-frequency oscillations in prefrontal structures together with a decrease of abnormal synchronization between different brain regions was observed, suggesting antipsychotic properties. Further, an overall comparison including clozapine, pimavanserin, and the experimental dopamine D3 receptor antagonist SB277011-A, indicated that mesdopetam was more similar to SB277011-A, than to the other compounds. The findings support that the dopamine D3 receptor play a role in PDP and further corroborates that dopamine D3 receptor antagonism is an important mechanism of action underlying the pharmacological effects of mesdopetam. About the journal Neurotherapeutics Neurotherapeutics is the journal of the American Society for Experimental Neurotherapeutics (ASENT). The journal publishes original research articles in translational neuroscience including descriptions of cutting edge therapies that cross disciplinary lines and represent important contributions to neurotherapeutics for medical practitioners and other researchers in the field. About IRLAB IRLAB is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson's disease. The company has its origin in Nobel Laureate Prof. Arvid Carlsson's research group and the discovery of a connection between the brain's neurotransmitters and CNS disorders. Mesdopetam (IRL790), in development for the treatment of levodopa-induced dyskinesias, has completed Phase IIb and is in preparation toward Phase III. Pirepemat (IRL752), is currently in Phase IIb, being evaluated for its effect on balance and fall frequency in Parkinson's disease. In addition, the company is also progressing the three preclinical programs IRL757 (financially supported by the Michael J. Fox Foundation), IRL942, and IRL1117 towards Phase I studies. IRLAB's pipeline has been generated by the company's proprietary systems biology-based Integrative Screening Process (ISP) research platform. Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit . Attachments IRLAB's mesdopetam displays antipsychotic properties in an advanced model of Parkinson's disease psychosis SOURCE: IRLAB Therapeutics View the original press release on accesswire.com

GOTHENBURG, SWEDEN / ACCESSWIRE / February 22, 2024 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, 22 February 2024 - IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson's disease, today announced that the company's recent End-of-Phase 2 meeting with the US Food and Drug administration, FDA, was held in a constructive and engaging spirit. The discussions during the meeting indicate alignment between the FDA and IRLAB on the design of the Phase III program. At the End-of-Phase 2 meeting with the FDA, aspects related to the Phase III program with mesdopetam were discussed. Prior to the meeting, IRLAB had provided the FDA with comprehensive information on mesdopetam generated through preclinical studies, toxicology, clinical pharmacology, and the outcomes of the clinical Phase Ib, Phase IIa and Phase IIb studies conducted in people living with Parkinson's and levodopa-induced dyskinesias. A proposal for the further development of mesdopetam was included in the information package. Based on this information, the FDA provided clear guidance that is substantially consistent with the proposed design of the Phase III-program for mesdopetam. Alignment with the FDA was reached on the key components of the Phase III program, including the primary and secondary endpoints, key inclusion and exclusion criteria and safety monitoring during the study period. "We had a very good meeting with the FDA where we reached alignment on the final design of the Phase III program for mesdopetam. It is gratifying to see that the extensive work with exploratory as well as mandatory regulatory studies that has been carried out meets requirements to move mesdopetam into a confirmatory clinical Phase III program," said Gunnar Olsson, CEO, IRLAB. More information about the study program will be communicated once the FDA has provided its formal feedback in the form of the official meeting minutes. IRLAB will receive the meeting minutes no later than 30 days after the meeting. This information is information that IRLAB Therapeutics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-02-22 08:30 CET. About IRLAB IRLAB is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson's disease. The company has its origin in Nobel Laureate Prof. Arvid Carlsson's research group and the discovery of a connection between the brain's neurotransmitters and CNS disorders. Mesdopetam (IRL790), in development for the treatment of levodopa-induced dyskinesias, has completed Phase IIb and is in preparation toward Phase III. Pirepemat (IRL752), is currently in Phase IIb, being evaluated for its effect on balance and fall frequency in Parkinson's disease. In addition, the company is also progressing the three preclinical programs IRL757 (financially supported by the Michael J. Fox Foundation), IRL942, and IRL1117 towards Phase I studies. IRLAB's pipeline has been generated by the company's proprietary systems biology-based Integrative Screening Process (ISP) research platform. Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit . About mesdopetam The investigational drug mesdopetam (IRL790), a dopamine D3 receptor antagonist, is being developed as a treatment for Parkinson's disease levodopa-induced dyskinesias (PD-LIDs). The objective is to improve the quality of life for people living with Parkinson's and having a severe form of involuntary movements commonly occurring after chronic levodopa treatment. Around 25-40 percent of all people being treated for Parkinson's develop LIDs, which equates to approximately 1.4-2.3 million people in the eight major markets globally (China, EU5, Japan and the US). Mesdopetam has also potential as a treatment for Parkinson's disease Psychosis (PD-P), and other neurological conditions such as tardive dyskinesia, representing an even larger market. The Phase Ib and Phase IIa studies showed a good safety and tolerability pro well as proof-of-concept with potential for a better anti-dyskinetic effect compared with current treatment options. A recently completed Phase IIb study showed that mesdopetam has a dose-dependent anti-dyskinetic and anti-parkinsonian effect in combination with a tolerability and safety pro par with placebo. The mesdopetam program is now undergoing preparations for Phase III. Attachments IRLAB has completed a successful End-of-Phase 2 meeting with the FDA on the design of the Phase III program for mesdopetam SOURCE: IRLAB Therapeutics View the original press release on accesswire.com

GOTHENBURG, SWEDEN / ACCESSWIRE / January 3, 2024 / IRLAB Therapeutics (STO:IRLAB-A) (FRA:6IRA) Gothenburg, Sweden, January 3, 2024 - IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson's disease, today announced that the US FDA has granted IRLAB an end-of-Phase 2 meeting for the mesdopetam program on February 20, 2024. "The end-of-Phase 2 meeting is an important milestone for the mesdopetam program. The further development activities, including the design of the Phase III program, will be discussed at the meeting and, thus, the path to a future New Drug Application (NDA) should be outlined. The outcome of the meeting is also important in IRLAB's business development activities for mesdopetam," said Gunnar Olsson, CEO, IRLAB. IRLAB is working together with the US advisory groups Clintrex, a clinical and regulatory strategy advisor and ProPharma Group (PPG), IRLAB's regulatory agent in the US, to develop the strategy for the mesdopetam Phase III program. IRLAB, PPG, and Clintrex have prepared the Briefing Book, which describes the full mesdopetam clinical and non-clinical development program and the scope and design of the planned randomized, placebo-controlled Phase III program. The purpose of an end-of-Phase 2 meeting is to ensure alignment with the US FDA prior to the start of Phase III. As part of the end-of-Phase 2 meeting, the US FDA evaluates the Phase III plans and study protocols combined with the data generated in previously completed studies, i.e. review of the safety pro assessment of the effectiveness of the drug candidate. The US FDA may, in addition, notify if any additional information is necessary to support a future New Drug Application (NDA). Information on the outcome of the meeting will be shared when IRLAB has received feedback from the US FDA, which could be up to 30 days after the meeting. For more information: Gunnar Olsson, CEO Phone: +46 70 576 14 02 E-mail: gunnar.olsson@irlab.se About mesdopetam The investigational drug mesdopetam (IRL790), a dopamine D3 receptor antagonist, is being developed as a treatment for Parkinson's disease levodopa-induced dyskinesias (PD-LIDs). The objective is to improve the quality of life for people living with Parkinson's and having a severe form of involuntary movements commonly occurring after chronic levodopa [NW1] treatment. Around 25-40 percent of all people being treated for Parkinson's develop LIDs, which equates to approximately 1.4-2.3 million people in the eight major markets globally (China, EU5, Japan and the US). Mesdopetam has also potential as a treatment for Parkinson's disease Psychosis (PD-P), and other neurological conditions such as tardive dyskinesia, representing an even larger market. The Phase Ib and Phase IIa studies showed a very good safety and tolerability pro well as proof-of-concept with potential for a better anti-dyskinetic effect compared with current treatment options. A recently completed Phase IIb study with 156 patients showed that mesdopetam has a dose-dependent anti-dyskinetic and anti-parkinsonian effect in combination with a tolerability and safety pro par with placebo. The mesdopetam program is now undergoing preparations for Phase III. About IRLAB IRLAB is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson's disease. The company has its origin in Nobel Laureate Prof. Arvid Carlsson's research group and the discovery of a connection between the brain's neurotransmitters and CNS disorders. Mesdopetam (IRL790), in development for the treatment of levodopa-induced dyskinesias, has completed Phase IIb and is in preparation toward Phase III. Pirepemat (IRL752), is currently in Phase IIb, being evaluated for its effect on balance and fall frequency in Parkinson's disease. In addition, the company is also progressing the three preclinical programs IRL757 (financially supported by the Michael J. Fox Foundation), IRL942, and IRL1117 towards Phase I studies. IRLAB's pipeline is driven by the company's proprietary systems biology-based Integrative Screening Process (ISP) research platform. Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit . Attachments IRLAB is granted an end-of-Phase 2 meeting with the FDA for the Phase III-ready mesdopetam program SOURCE: IRLAB Therapeutics View the original press release on accesswire.com