D&D Pharmatech Co., Ltd.

The Fast Track designation accelerates DD01’s path to U.S. FDA submission for the treatment of adults with MASLD/MASH GYEONGGI-DO, South Korea & GAITHERSBURG, Md.--(BUSINESS WIRE)-- D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases. The FDA based its decision on data from Phase 1, a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of DD01 in overweight/obese subjects with type 2 diabetes (T2D) and metabolic dysfunction-associated fatty liver disease (MAFLD). In that study, DD01 treatment was well tolerated and reduced hepatic steatosis by >50% in only 4 weeks with up to 100% of subjects achieving ≥30% liver fat reduction by MRI-PDFF. In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH. Weight loss and improved glycemic control were also observed. For many patients, co-occurring type 2 diabetes and obesity are underlying factors. Preclinical and clinical results suggest DD01 treatment may be beneficial in the treatment of fatty liver disease and can improve glycemic control and weight loss in subjects who are overweight or have type 2 diabetes. “We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D. “MASH has a significant unmet need. Multiple clinical trials have recently proven that efficiently reducing excessive liver fat content leads to ameliorating MASH and liver scarring. DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.” About DD01 DD01 is a proprietary, once-weekly dual agonist of GLP-1 (glucagon-like peptide-1) and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and MAFLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment from MAFLD patients. In preclinical studies, DD01 caused significant weight loss, reduced liver fat and fibrosis, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates. About D&D Pharmatech D&D Pharmatech is a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty. This corporate structure creates a unique opportunity to accelerate the translation of cutting-edge research into lifesaving therapeutic products for patients. The company’s product pipeline focuses on metabolic diseases, including obesity, MASH and fibrosis, and neurodegenerative diseases. For more information, please visit . Neuraly Inc. is a wholly owned US subsidiary of D&D Pharmatech. View source version on businesswire.com: Contacts Neuraly Inc. Ben Gibson 240-937-5876 bgibson@neuralymed.com Source: D&D Pharmatech, Inc. 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

- Study results demonstrate DD01 was safe and well-tolerated at doses highly effective in reducing fatty liver. - Following only 4 weeks of treatment, all subjects in high dose group achieved at least a 40% reduction in liver fat with a mean reduction of >50% measured by MRI-PDFF (p < 0.0001 v.s. placebo group). - DD01 provides a unique balance of GLP-1/Glucagon activity that achieves rapid reductions in liver fat even without the weight loss observed at higher doses, thus offering the potential to treat fatty liver disease independent of the long-term treatment needed to achieve the same effect with an incretin alone. GYEONGGI-DO, South Korea & GAITHERSBURG, MD, USA I May 02, 2023 I D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, today announced positive topline results from its Phase 1 clinical trial of DD01 in overweight/obese patients with type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD). DD01 is a long-lasting, dual GLP-1/glucagon receptor agonist designed to rapidly resolve hepatic steatosis, improve glycemic control, and reduce body weight in fatty liver disease with and without co-occurring T2D and obesity. This trial was a randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) studies performed at four clinical sites in the U.S. Eligible participants included T2D who are overweight/obese for SAD study and obese with T2D and NAFLD for MAD study with a minimum body mass index (BMI) of 30 kg/m2 and hepatic fat contents of ≥10% by MRI-PDFF. A total hundred-seven (107) subjects were enrolled, and fifty (50) subjects in the MAD portion were assigned to receive subcutaneous doses of DD01 at up to 80 mg or placebo once weekly for four weeks without dose titration. The trial was designed to assess the safety, pharmacokinetics, and pharmacodynamic effects of DD01. DD01 was generally safe and well tolerated with gastrointestinal adverse events like those reported for selective GLP-1 receptor agonists. Following only four (4) weeks of once-weekly treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF. A mean relative reduction in liver fat content of >50% was observed in a pooled analysis of the two high doses of DD01, whereas the change from baseline in placebo-treated subjects was <5%. Rapid improvements in steatosis were observed at well-tolerated doses and accompanied by increased insulin, decreased HbA1c, and weight loss at higher doses. In obese, diabetic subjects with NAFLD, the dual-pathway effect of DD01, acting through both the GLP-1 and glucagon receptor, was apparent and beneficial to these commonly co-morbid conditions. Presentation of clinical data showing the effects of DD01 and preclinical data illustrating highlights of the underlying mechanism of action is planned for upcoming conferences in 2023. “We are thrilled to receive the positive topline results from this initial trial that show DD01 has strong potential to rapidly reduce fatty liver independent of the longer-term goal of weight loss recommended for some patients. Due to its rapid action and beneficial effects on glucose control, DD01 may provide an effective adjunct to diet and exercise in these patients, uncoupling the need for weight loss to precede improvements in liver health,” said Adam Bell, Ph.D., VP of Translational Medicine and Regulatory Affairs. “Direct targeting of fatty liver has proven beneficial in NASH patients. A ≥30% reduction in liver fat is associated with a clinically significant improvement in NASH scores. In NAFLD, DD01 achieved and exceeded this level in only 4 weeks,” added Seulki Lee, Ph.D., President, and Chief Executive Officer of D&D Pharmatech. “With these positive results, we look forward to conducting a Phase 2 study to further validate the utility of DD01 in the treatment of NAFLD and NASH both with and without co-occurring obesity and diabetes.” More information about the study is available at www.clinicaltrials.gov under the identifier NCT04812262. Clinical Implications At present, there are no treatments for nonalcoholic fatty liver disease. While both pre-diabetic and diabetic patients routinely present with fatty liver disease, doctors typically recommend weight loss, which can be effective but is slow and, for many patients, proves challenging. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment. One could easily envision using DD01 as an adjunct to diet and exercise to improve liver health rapidly. Patients may achieve rapid reductions in liver fat while benefiting over the long term from improved glycemic control and weight loss. About DD01 DD01 is a proprietary, long-acting dual agonist of GLP-1 and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and NAFLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. Treatment with DD01 caused significant weight loss, reduced liver fat, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates. About D&D Pharmatech D&D Pharmatech is a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty. This corporate structure creates a unique opportunity to accelerate the translation of cutting-edge research into lifesaving therapeutic products for patients. The company’s product pipeline focuses on various indications, including neurodegenerative, fibrotic, and metabolic diseases. For more information, please visit http://www.ddpharmatech.com/ . SOURCE: D&D Pharmatech