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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

Milestone achieved for SENS-501 gene therapy program with Clinical Trial Application approval in Europe (France as first country) Communication on first patient expected in H2 2024 GJB2 gene therapy program advancing towards Clinical Trial Applications filing expected in Q2 2025 Primary endpoint met in Phase 2a clinical trial of SENS-401 in the preservation of residual hearing following cochlear implantation Presence of SENS-401 detected in 100% of patients sampled at levels compatible with potential therapeutic efficacy Final data readout expected in Q3 2024 Continued progress for SENS-401 in Phase 2a clinical trial in the prevention of Cisplatin-Induced Ototoxicity Preliminary safety and efficacy data readout expected at the World Congress of Audiology in September 2024 Completion of two financing rounds, raising €35 million in August 2023 and €50.5 million in February 2024, enabling the company to extend its cash runway through the end of Q2 2025 MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update. Nawal Ouzren, Chief Executive Officer of Sensorion, said: “Over the past months, Sensorion has successfully achieved all the major milestones on its roadmap. Our pioneering gene therapy, SENS-501, is entering clinical development, and our small molecule, SENS-401, has met primary endpoint in its most advanced indication: residual hearing preservation after cochlear implantation, in a Phase 2a study. At the same time, we have succeeded in securing financing for our operations until mid-2025 with the support of international and long-term investors. Sensorion is well equipped to meet its operational objectives for 2024, to continue bringing innovative therapeutic solutions to patients in the field of hearing, and to create value for its shareholders.” Pipeline Highlights and Upcoming Milestones In 2023, Sensorion continued to develop innovative therapies to restore hearing, to treat and prevent hearing loss, and potentially transform quality of life for patients suffering from hearing loss disorders. Gene Therapies for Hereditary Monogenic Hearing Loss Sensorion continues to advance its gene therapy programs, developed as part of its collaboration with the Institut Pasteur, initiated in 2019, and extended for an additional 5-year period in January 2024. The framework agreement for a research partnership grants Sensorion an exclusive option to obtain an exclusive license to develop and commercialize drug candidates in gene therapy for the restoration of hearing. The company has made significant progress in its gene therapy pipeline with the submission and approval of clinical trial application for SENS-501 in Europe, and the candidate selection for GJB2-GT. The company has expanded its technical development capabilities over the period along with pilot-scale non-GMP (Good Manufacturing Practices) manufacturing capacity. SENS-501: Milestone achieved with Audiogene Clinical Trial Application approval in Europe. First patient communication anticipated in H2 2024 Sensorion’s SENS-501 (OTOF-GT) dual AAV vector gene therapy development product aims at restoring hearing in patients with mutations in OTOF gene who suffer from severe to profound sensorineural prelingual non syndromic hearing loss. The otoferlin is a protein expressed in the inner hair cells (IHC) present in the cochlea and is critical for the transmission of the signal to the auditory nerve. Otoferlin related hearing loss is responsible for up to 8% of all cases of congenital hearing loss, with around 20,000 people affected in the US and Europe1. Sensorion’s lead gene therapy program, SENS-501, has been developed as part of its collaboration focused on the genetics of hearing with the Institut Pasteur. In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV SENS-501 clinical batches at 200L scale. The production will enable the Company to cover the needs for the envisioned Phase 1/2 gene therapy clinical trial. Following the positive feedback from Scientific Advice meetings with regulatory agencies EMA (European Medicines Agency), ANSM (French National Agency for Medicines and Health Products Safety) and the UK’s MHRA (Medicines and Healthcare product Regulatory Agency), Sensorion has submitted a Clinical Trial Application (CTA) to initiate a Phase 1/2 clinical trial of SENS-501 to the UK’s MHRA on July 10, 2023, and in Europe on July 19, 2023. In parallel, Sensorion submitted a Medical Device Application for the injection system. On January 19, 2024, Sensorion announced the approval to initiate the Phase 1/2 clinical trial of SENS-501, Audiogene, in Europe (France as first country). The CTA approval follows extensive preclinical studies assessing the safety and efficacy of SENS-501 and successful GMP manufacturing of the gene therapy Drug Product for the clinical trial. Audiogene aims to evaluate the safety, tolerability, and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing impairment in paediatric patients aged 6 to 31 months at the time of gene therapy treatment. Targeting the first years of life, the time period when the auditory system plasticity is optimal, will maximize the chances of these young children with pre-lingual hearing loss to acquire normal speech and language. Audiogene will also assess the clinical safety, performance, and usability of the administration device system under development in partnership with EVEON. The design of the study will consist of two cohorts at two different doses followed by an expansion cohort at the selected dose. While the safety will be the primary endpoint for the dose escalation cohorts, the auditory brainstem response (ABR) will be the primary efficacy endpoint of the dose expansion cohort. Sensorion will communicate on the first patient in the course of H2 2024 and expects the recruitment completion of the first two cohorts of patients in H1 2025. GJB2-GT: Moving forward towards Clinical Trial Applications submission in Q2 2025 Sensorion's GJB2 gene therapy program, initiated in 2021 and developed in collaboration with the Institut Pasteur, has the potential to address three pathologies related to GJB2 mutations: early onset of presbycusis in adults, progressive forms of hearing loss in children, and pediatric congenital deafness. Although the types of GJB2 mutations in children and adults may differ, gene therapy offers potential solutions for both. On April 6, 2023, Sensorion announced the candidate selection for GJB2-GT during its gene therapy focused R&D Day. The candidate designed with a specific adeno-associated virus (AAV) capsid safely targets key cells in the ear that normally express GJB2. Sensorion has acquired bioreactors and has completed the non-GMP process development of the GJB2 candidate up to 50L scale. Process and analytical methods will be transferred to the CDMO selected by the Company for the GMP production of the clinical batch. Sensorion is advancing the candidate into IND/CTA enabling activities for future clinical development and anticipates the submission of the Clinical Trial Applications in Q2 2025. SENS-401: Sensorion’s small molecule for the prevention of hearing loss SENS-401(Arazasetron) is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible for hearing impairment. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss (SSNHL), and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population. Sensorion is developing SENS-401 in two Proof of Concept (POC) Phase 2a clinical trials. The first one is designed to assess SENS-401 for residual hearing preservation during cochlear implantation in partnership with Cochlear Limited (Cochlear), the global leader in implantable hearing solutions, and the second one is a trial assessing SENS-401 in Cisplatin-Induced Ototoxicity prevention (CIO) in adult patients undergoing a cisplatin-based chemotherapy. SENS-401 to prevent residual hearing loss after cochlear implantation. Milestone achieved with primary endpoint met. Final data readout planned in Q3 2024 Sensorion is developing SENS-401 in a multicentric, randomized, controlled open-label Phase 2a clinical trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult patients prior to cochlear implantation due to moderately severe to profound hearing impairment. Patients continue to receive SENS-401 for a further 42 days after implantation. In June 2023, Sensorion released preliminary data from its Phase 2a study, showing that SENS-401 was detected in the perilymph of all five adult patients treated with the product. Levels of SENS-401 were considered consistent with potential therapeutic effects after seven days of repeated oral treatment. In July 2023, the Company reported further analysis during its KOL webinar suggesting that SENS-401 treated patients demonstrated a clinically significant 21 dB improvement in the preservation of their residual hearing compared to the control group six weeks after cochlear implantation at 500 Hz. Indeed, in the SENS-401-treated group (N=5), the loss of residual hearing was only 12 dB, contrasting with a larger loss of 33 dB observed in the control group of four participants not treated with SENS-401. These findings reinforce the hypothesis that SENS-401, by crossing the labyrinthine barrier to reach the cochlear compartment, has a positive effect on the preservation of residual hearing. On February 1, 2024, Sensorion announced the completion of patient inclusion in the Phase 2a POC clinical trial, with 28 patients recruited in the study in total. Following this announcement, Sensorion communicated on March 11, 2024, that a total of 28 patients have been randomized and 25 patients have been implanted with a cochlear implant, 16 in the treated arm and 9 in the control non-treated arm. The presence of SENS-401 in the perilymph at a level compatible with potential therapeutic efficacy has been confirmed in 100% of the patients sampled, 7 days after the start of the treatment, confirming that the primary endpoint was met. The study is now completed, the follow-up of the last patients is still ongoing and the secondary endpoints including results on the preservation of the residual hearing will be available and analyzed later this year. The Company plans to publish the complete readout of the study in Q3 2024. SENS-401 to prevent Cisplatin Induced Ototoxicity (CIO) progressing as planned with efficacy and safety preliminary data expected in September 2024 Cisplatin and other platinum compounds are essential chemotherapeutic agents for many malignancies. Unfortunately, platinum-based therapies cause ototoxicity and hearing loss, which are permanent, irreversible and particularly harmful in about 60% of adult and pediatric patients treated. This indication represents a very significant unmet need for patients and is an attractive market with more than 500,000 patients forecast in 2025 in the G7 countries. SENS-401 is progressing in NOTOXIS, a multicenter, randomized, controlled, open-label Phase 2a clinical study, designed to evaluate the efficacy of SENS-401 to prevent CIO in adult patients with a neoplastic disease four weeks after the completion of cisplatin-based chemotherapy. The trial assesses several outcome measures, including the rate and severity of ototoxicity, the change from baseline in Pure Tone Audiometry (PTA) (dB) throughout the study and the tolerance. Eligible participants are randomized on Day 1 to either Arm A or Arm B in ratio 1:1. In Arm A, patients receive 43.5mg of oral SENS-401 one week before the start of the chemotherapy, continues throughout the entire chemotherapy duration, and extends for four weeks post-chemotherapy. This study is conducted in comparison to a control group of patients receiving chemotherapy alone, Arm B. The patients entering the study are to receive high doses of cisplatin, exceeding 70mg/m2 per treatment cycle and totaling at least 210 mg/m2 over the course of their chemotherapy regimen. In December 2023, Sensorion announced that over one-third of the required study population had been recruited and that preliminary safety data for patients exposed to a daily dose of 43.5 mg SENS-401 administered b.i.d. for up to 11 weeks indicated a favorable pro with previously reported data for patients exposed for up to 7 weeks. Recruitment is progressing at a sustained path, with eleven clinical centers open as of December 18, 2023. Sensorion’s management team will communicate preliminary efficacy and safety data of the POC Phase 2a clinical study of SENS-401 in CIO during the World Congress of Audiology, held on September 19-22, 2024, in Paris, France. Strengthening the Board of Directors and senior leadership On March 31, 2023, Sensorion appointed Khalil Barrage as interim Chairman of the Board. Mr. Barrage has served on the Board of Sensorion for over three years, supporting with several capital raises and providing leadership on the Company’s evolution towards becoming a gene therapy-focused company. He has been a managing director at Invus Group, a major investor in Sensorion, for nearly 20 years, heading its Public Equity group and serves on the Boards of Elevate Bio, Valerio Therapeutics, Orthobond and Protagenic Therapeutics. On August 3, 2023, following the completion of the private placement, Redmile Group (represented by Natalie Berner) became a board member in replacement of Bpifrance Investissement, whose permanent representative was Jean-François Morin. On December 12, Sensorion announced the appointment of CMC (Chemistry, Manufacturing and Control) expert Bernd Schmidt as Chief Technical Officer. He brings over 20 years of industry experience in the pharmaceutical sector, covering a broad range of innovative medicines at different stages in development and post launch. On January 25, 2024, Sensorion announced the nomination of Dr. Federico Mingozzi as Non-Executive Director to the Board of Directors. Mr. Mingozzi brings over 25 years of experience in gene therapy, immunology, as well as biochemistry and molecular biology in academia and industry. 2024 Outlook As of December 31, 2023, the Company had €37.0 million in cash and cash equivalents. Based on this cash position, the net proceeds from the €50.5 million financing announced on February 9, 2024, and its forecasted expenses, the company expects it will be able to finance its operations up until the end of Q2 2025. In 2024, Sensorion plans on pursuing developments across its portfolio of innovative programs with the aim of treating, restoring and preventing hearing disorders and improving the quality of life of patients suffering from hearing disorders. The Company plans to communicate about the first patient enrolled in Audiogene, its Phase 2a clinical trial of its gene therapy product, SENS-501, in H2 2024. The Company is on track to submit Clinical Trial Applications for its second gene therapy, GJB2-GT, in H1 2025, with ongoing IND/CTA-enabling preclinical activities. In parallel, SENS-401, Sensorion’s orally available small molecule, is progressing in two Phase 2a clinical trials. Final data readout is expected in Q3 2024 for its trial of SENS-401 in the prevention of residual hearing loss following cochlear implantation, and preliminary safety and efficacy are expected in September 2024 during the World Congress of Audiology for its second ongoing clinical trial of SENS-401, in the prevention of Cisplatin-Induced Ototoxicity. Expected next clinical milestones: Q3 2024 – SENS-401 in combination with cochlear implantation: Final data readout H2 2024, World Congress of Audiology – SENS-401 in Cisplatin-Induced Ototoxicity: Preliminary safety and efficacy data H2 2024 – SENS-501: First patient communication H1 2025 – SENS-501: Enrollment of the first two cohorts of Phase 1/2 Audiogene trial completed Q2 2025 – GJB2-GT: Clinical Trial Applications Submission Full Year 2023 financial highlights Cash Position Cash & Cash Equivalents amounted to €37.0 million as at December 31, 2023, compared to €26.2 million at December 31, 2022. Research And Development (R&D) Expenses R&D expenses decreased by 0.7 % from €22.9 million in 2022 to €22.8 million in 2023. General And Administrative (G&A) Expenses G&A expenses were €5.3 million for 2023, compared to €5.2 million for 2022. Net Loss Net loss was -€22.1 million for 2023, compared to -€23.2 million for 2022. Financial guidance Based on cash and cash equivalents of €37.0 million at 31 December 2023, and the net proceeds of a €50.5 million offering of new shares announced on February 9, 2024, amounting to c. €47 million, the Company has sufficient net working capital to meet its cash requirements beyond the next twelve months, i.e. until the end of Q2 2025. Financial results The annual accounts as at December 31, 2023, were prepared according to IFRS standards and approved by the Board of Directors on March 13, 2024. The simplified income statement as of December 31, 2023, is as follows: In thousands of Euros – IFRS standards 31.12.2023 31.12.2022 Operating income 5,698 5,006 Research & Development expenses -22,756 -22,925 General & Administrative expenses -5,252 -5,217 Total operating expenses -28,008 -28,142 Operating loss -22,310 -23,137 Financial result 544 -72 Corporate Income Tax -297 0 Net loss -22,063 -23,209 The simplified balance sheet at December 31, 2023, is as follows: In thousands of Euros – IFRS standards 31.12.2023 31.12.2022 Non-current Assets 3,236 3,176 Other Current Assets 6,293 9,565 Cash & cash equivalent 36,974 26,204 Total Assets 46,503 38,945 Equity 33,276 21,885 Non-current Liabilities 2,950 3,467 Current Liabilities 10,278 13,593 Total Liabilities 46,503 38,945 2023 certified accounts On March 13, 2024, the Board of Directors approved the Company’s full year results as of December 31, 2023. The Full Year Financial Report can be found on Sensorion’s website ( ) in the investor section under financial information. The full year accounts of 2023 have been subject to a limited review by the Company’s statutory auditors and an unqualified report is being issued. About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) targets deafness caused by mutations of the gene encoding for otoferlin and is currently developed in a Phase 1/2 clinical study, and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year financial report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. 1 Rodríguez-Ballesteros M, Reynoso R, Olarte M, Villamar M, Morera C, Santarelli R, Arslan E, Medá C, Curet C, Völter C, Sainz-Quevedo M, Castorina P, Ambrosetti U, Berrettini S, Frei K, Tedín S, Smith J, Cruz Tapia M, Cavallé L, Gelvez N, Primignani P, Gómez-Rosas E, Martín M, Moreno-Pelayo MA, Tamayo M, Moreno-Barral J, Moreno F, del Castillo I. A multicenter study on the prevalence and spectrum of mutations in the otoferlin gene (OTOF) in subjects with nonsyndromic hearing impairment and auditory neuropathy. Hum Mutat. 2008 Jun;29(6):823-31. doi: 10.1002/humu.20708. PMID: 18381613. View source version on businesswire.com: Contacts Investor Relations Noémie Djokovic, Investor Relations and Communications Associate ir.contact@sensorion-pharma.com Press Relations Ulysse Communication Pierre-Louis Germain / +33 (0)6 64 79 97 51 plgermain@ulysse-communication.com Bruno Arabian / +33(0)6 87 88 47 26 barabian@ulysse-communication.com Source: Sensorion View this news release online at:

The psychosis in Parkinson's and Alzheimer's disease market size shall grow during the forecast period (2023–2032). This increase will be due to rising disease awareness and improving diagnosis, besides the launch of emerging therapies by key companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, and others. LAS VEGAS, May 16, 2023 /PRNewswire/ -- DelveInsight's Psychosis in Parkinson's and Alzheimer's Disease Market Insights report includes a comprehensive understanding of current treatment practices, psychosis in Parkinson's and Alzheimer's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Psychosis in Parkinson's and Alzheimer's Disease Market Report As per DelveInsight analysis, the psychosis in Parkinson's and Alzheimer's disease market size in the 7MM was approximately USD 1.2 billion in 2022. According to the assessment done by DelveInsight, the estimated total diagnosed prevalent psychosis in Parkinson's and Alzheimer's disease cases in the 7MM were approximately 6.7 million in 2022. Leading psychosis in Parkinson's and Alzheimer's disease companies such as Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, and others are developing novel psychosis in Parkinson's and Alzheimer's disease drugs that can be available in the psychosis in Parkinson's and Alzheimer's disease market in the coming years. The promising psychosis in Parkinson's and Alzheimer's disease therapies in the pipeline include Ulotaront (SEP-363856), KarXT (xanomeline-trospium), FANAPT (iloperidone), Masupiridine (SUVN-502), ENT-01, ITI-1284, MK-8189 , and others. Discover which therapies are expected to grab the major psychosis in Parkinson's and Alzheimer's disease market share @ Psychosis in Parkinson's and Alzheimer's Disease Market Report Psychosis in Parkinson's and Alzheimer's Disease Overview Psychosis is a group of symptoms that affect the mind and indicate a loss of contact with reality. Individuals' ideas and perceptions are altered during a psychotic episode, making it difficult to distinguish between what is genuine and what is not. In Parkinson's disease and Alzheimer's disease, both exogenous and endogenous factors contribute to the development of psychosis. Old age, sleep difficulties, long-term neurodegenerative conditions, depression, cognitive impairment, and vision abnormalities are all risk factors for the disease. Parkinson's disease psychosis (PDP) is a prevalent occurrence in Parkinson's disease patients that is associated with significant morbidity and mortality. It is caused by anomalies in dopamine, serotonin, and glutamate neurotransmission induced by Lewy body deposition in the brain. Alzheimer's disease psychosis (ADP), which is common in Alzheimer's disease patients, is caused by increased excitatory neuron sensitivity and post-transcriptional mechanisms that alter synaptic protein in the brain. Due to the complexity of the aetiologies and physiological hypotheses, many diagnostic techniques, including neuroimaging, neurophysiological, genotypic, and serologic examinations, are used to diagnose psychosis in Parkinson's and Alzheimer's disease patients. Psychosis in Parkinson's and Alzheimer's Disease Epidemiology Segmentation DelveInsight estimates that there were approximately 6.7 million diagnosed prevalent cases of psychosis in Parkinson's and Alzheimer's disease in the 7MM in 2022. Among the 7MM, the US contributed to the largest diagnosed prevalent psychosis population in Parkinson's and Alzheimer's disease, acquiring ~34% in 2022. In contrast, the UK accounted for the least, with approximately 4% of the total population share in 2022. The psychosis in Parkinson's and Alzheimer's disease market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total diagnosed prevalent cases of Parkinson's and Alzheimer's disease Age-specific cases of Parkinson's and Alzheimer's disease Gender-specific cases of Parkinson's and Alzheimer's disease Total diagnosed prevalent cases of Psychosis in Parkinson's and Alzheimer's disease Psychosis in Parkinson's and Alzheimer's Disease Treatment Market The current treatment of psychosis in Parkinson's and Alzheimer's disease includes both nonpharmacological and pharmacological treatments. The major goal of psychosis in Parkinson's and Alzheimer's disease treatment is to lessen the frequency and severity of psychotic symptoms while causing little worsening of motor symptoms. The use of conventional and atypical antipsychotics (e.g., aripiprazole, clozapine, quetiapine, and others) is the first-line treatment. However, atypical antipsychotics are frequently chosen in the initial therapy, which minimizes the likelihood of further worsening in patients. Aside from antipsychotics, 5-HT3 receptor antagonists, acetylcholinesterase inhibitors (donepezil, rivastigmine), and various antidepressants are utilized. While cognitive behavioral therapy (CBT), reasoning, and rehabilitation are used to reduce behavioral and psychological symptoms of dementia (BPSD), anxiety, psychosis, agitation, aggression, sleep difficulties, and other symptoms linked with psychosis in Parkinson's and Alzheimer's disease. The US FDA has approved ACADIA's NUPLAZID (pimavanserin), a receptor antagonist (5-HT2A, 5-HT2C), for the treatment of hallucination and delusion associated with psychosis in Parkinson's disease patients. It is the only approved therapy available in the US. Recent trials also suggest that the medicine is helpful in Alzheimer's disease patients with more severe psychosis. At the same time, more long-term studies are needed to define better the efficacy and long-term safety profile of pimavanserin for treating psychosis in Alzheimer's disease. Though the expensive cost of pimavanserin certainly restricts its use, the findings in Parkinson's disease psychosis patients and evidence from Alzheimer's disease trials are convincing. There are currently no approved medicines for Alzheimer's disease psychosis patients; the major treatment is antipsychotics. Off-label therapies that are routinely utilized include quetiapine, clozapine, risperidone, aripiprazole, citalopram, and escitalopram. Aripiprazole has been shown in clinical tests to be effective and safe. In contrast, citalopram has been shown to be useful in lowering agitation and the severity of hallucinations and delusions in Alzheimer's disease psychosis patients. To know more about psychosis in Parkinson's and Alzheimer's disease treatment guidelines, visit @ Psychosis in Parkinson's and Alzheimer's Disease Management Psychosis in Parkinson's and Alzheimer's Disease Pipeline Therapies and Key Companies Ulotaront (SEP-363856): Sunovion Pharmaceuticals KarXT (xanomeline-trospium): Karuna Therapeutics FANAPT (iloperidone): Vanda Pharmaceuticals Masupiridine (SUVN-502): Suven Life Sciences ENT-01: Enterin ITI-1284: Intra-Cellular Therapies MK-8189: Merck Sharp & Dohme Learn more about the FDA-approved drugs for psychosis in Parkinson's and Alzheimer's disease @ Drugs for Psychosis in Parkinson's and Alzheimer's Disease Treatment Psychosis in Parkinson's and Alzheimer's Disease Market Dynamics The psychosis in Parkinson's and Alzheimer's disease market dynamics are anticipated to change in the coming years due to increasing awareness and improved diagnosis. Increased awareness and a better understanding of disease pathogenesis have improved diagnosis and treatment. Moreover, the recent FDA approval of NUPLAZID, the first approved therapy for treating hallucinations and delusions associated with Parkinson's disease psychosis, suggests a positive shift in the psychosis in Parkinson's and Alzheimer's disease market. Furthermore, pharma companies have an opportunity to develop therapies with enhanced safety and tolerability profiles, effectively lowering symptoms and preventing the recurrence of psychosis in Parkinson's and Alzheimer's disease. In addition, the advancement of biomarkers for cognitive impairment enables exact diagnosis and individualized therapy. However, several factors are impeding the growth of psychosis in the Parkinson's and Alzheimer's disease market. Psychosis in Parkinson's disease and Alzheimer's disease is related to low quality of life, higher healthcare resource utilization, and a significant economic burden. NUPLAZID and the other atypical antipsychotics recommended for treatment include black box warnings and adverse effects. Moreover, a lack of a medication development pipeline, the ongoing use of antipsychotics despite the hazards, and a lack of specialized nonpharmacological interventions may cause a dip in the growth of psychosis in the Parkinson's and Alzheimer's disease market. Furthermore, there is a high attrition rate when drug development proceeds from first-in-human trials to pivotal registration studies due to a lack of efficacy. Hence all these factors may hamper the psychosis in Parkinson's and Alzheimer's disease market growth in the coming years. Scope of the Psychosis in Parkinson's and Alzheimer's Disease Market Report Therapeutic Assessment: Psychosis in Parkinson's and Alzheimer's Disease current marketed and emerging therapies Psychosis in Parkinson's and Alzheimer's Disease Market Dynamics: Attribute Analysis of Emerging Psychosis in Parkinson's and Alzheimer's Disease Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Psychosis in Parkinson's and Alzheimer's Disease Market Access and Reimbursement Discover more about psychosis in Parkinson's and Alzheimer's disease drugs in development @ Psychosis in Parkinson's and Alzheimer's Disease Clinical Trials Table of Contents Related Reports Parkinson's Disease Psychosis Pipeline Parkinson's Disease Psychosis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease psychosis companies, including Vanda Pharmaceuticals, Sumitomo Pharma, among others. Psychosis Market Psychosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis companies, including Teva Pharmaceutical Industries Ltd., Amgen Inc., Pfizer Inc., Novartis International AG., Merck & Co. Inc., Sanofi S.A., among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Vanda Pharmaceuticals, Sumitomo Pharma, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including AZTherapies, Cerecin, Neurotrope, Lyndra, AC Immune, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP