Chronic Periodontitis

Novel Trial to Study the Reduction of Certain Pathogens Following Scaling and Root Planing Procedure LAVAL, QC / ACCESSWIRE / May 18, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its oral health care business, OraPharma, Inc., today announced the publication of a new study, which showed that ARESTIN® (minocycline HCI) microspheres, 1mg decreased certain pathogenic burdens, also known as infection burdens, in adults with periodontitis when applied immediately after scaling and root planning (SRP) and again at a three-month reapplication, versus SRP alone. ARESTIN is an FDA-approved antibiotic applied locally to gum pockets in adults with periodontitis following an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines. The investigator-initiated trial, sponsored in part by Bausch Health, and conducted by researchers from the University of Minnesota School of Dentistry, appeared today in the Journal of Periodontology. The study showed minocycline application immediately after initial SRP and reapplication at 3-months after SRP decreased certain key pathogens and may have contributed to improvements in probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP) and gingival index (GI) compared to SRP alone. "Dental practices need to think about periodontal disease and the role of keystone pathogens that originate in the mouth, can travel, and may be associated with other systemic outcomes such as diabetes and cardiovascular disease," said Richard Nagelberg, DDS, Director of Medical Affairs at Bausch Health. "This study represents an important path forward in helping to manage periodontal disease and we hope it encourages further research in the area of periodontal disease progression and how it may relate to the oral-systemic connection." Since the pivotal trial, there was a gap in the literature on whether minocycline HCI microspheres, 1mg reduced specific periodontal pathogens. This study identified that the administration of minocycline HCI microspheres, 1mg did significantly decrease specific periodontal pathogens. The objective of the study entitled, Effect of Scaling and Root Planing With and Without Minocycline HCl Microspheres on Periodontal Pathogens and Clinical Outcomes: A Randomized Clinical Trial, was to determine if minocycline HCl plus SRP contributed to the improvement of certain clinical measures commonly seen in patients with gum disease. A secondary endpoint was to determine if minocycline microspheres HCl with SRP lowered specific pathogens responsible for periodontitis compared to SRP alone. Saliva and clinical outcomes were collected for both groups at baseline before SRP, 1-month reevaluation, and at 3 and 6-month periodontal recall. Minocycline microspheres (MM) were delivered to pockets ≥5 mm immediately after SRP and immediately after the 3-month periodontal maintenance. This study reported that of the 11 pathogens that play an instrumental role in periodontitis, there were six periodontal pathogens that had a statistically significant decrease at 1-month and four periodontal pathogens with a statistically significant decrease at the 6-month periodontal maintenance versus the SRP group alone. This study also reported that minocycline HCI plus SRP achieved greater improvement for probing depth, bleeding on probing, gingival index, and improvement in clinical attachment loss by the six-month periodontal maintenance versus SRP alone. Limitations of the study include the lack of a blinded examiner for clinical outcomes and lack of patient-reported outcome measures. The principal investigator (PI) collected saliva, recorded clinical measures and provided treatment for both groups. The participants in this study were predominantly from the Midwestern region, Caucasian and over the age of 50 years old, which does not represent the general population of individuals with periodontitis. "There was a larger decrease of Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum/periodonticum, Prevotella intermedia, Parvimonas micra and Eikenella corrodens in the SRP + MM group," said Dr. Nagelberg. It is notable that minocycline HCl microspheres, 1mg immediately following SRP procedures reduced these specific periodontal pathogens by the 1-month reevaluation. The previous pivotal study (Williams et al., 2001) was conducted to determine if minocycline HCI plus SRP reduced pocket depth in patients with generalized moderate to advanced adult periodontitis versus SRP alone. Subjects treated with minocycline HCI plus SRP were found to have statistically significantly reduced probing pocket depth compared with those treated with SRP alone or SRP + vehicle at 9 months after initial treatment. About the Study A total of 70 participants were randomized to receive SRP alone, or SRP with minocycline HCl microspheres, 1mg following the procedure, and again at the 3-month periodontal visit. Participants in both groups received periodontal evaluations at baseline, one month, three months and six months following the initial SRP procedure. The primary goal of this study was to determine the adjunctive effects of minocycline microspheres (MM) on clinical outcomes of PD, CAL, BOP, and GI after SRP+MM compared to SRP alone. Secondary outcome variables were the relative numbers of 11 periodontal pathogens in saliva after SRP+MM compared to SRP alone. The bacterial load and pathogenic burden were determined using a salivary test. Microorganisms and secondary periodontal measurements were compared between groups using generalized linear mixed-effects models, with fixed effects for group, visit, site (for clinical measurements), and group-by-visit and group-by-site interactions, and random effects for participant and site within participant. Mean changes from baseline were compared between groups via group-by-visit interaction tests. The six periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP alone group at the one-month follow-up visit were Tannerella forsythia (Tf) (0.003), Treponema denticola (Td) (0.01), Fusobacterium nucleatum/periodonticum (Fn/Fp)(0.0009), Prevotella intermedia (Pi) (0.04), Parvimonas micra (Pm) (<0.0001), and Eikenella corrodens (Ec) (0.02). Further, the four periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP alone group at the final six-month visit were Fusobacterium nucleatum/periodonticum (Fn/Fp) (0.02), Prevotella intermedia (0.05), Campylobacter rectus (Cr) (0.04) and Eikenella corrodens (0.0002). Limitations of the study include the lack of a blinded examiner for clinical outcomes and lack of patient-reported outcome measures. The principal investigator (collected saliva, recorded clinical measures and provided treatment for both groups. The participants in this study were predominantly from the Midwestern region, Caucasian and over the age of 50 years old, which does not represent the general population of individuals with periodontitis. The statistical analysis for this research was supported by a grant from the National Institutes of Health's National Center for Advancing Translational Science. Important Safety Information for ARESTIN® INDICATION ARESTIN® (minocycline HCl) Microspheres, 1mg is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP. IMPORTANT SAFETY INFORMATION ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines. Hypersensitivity reactions and hypersensitivity syndrome that included, but were not limited to anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may be present. Swelling of the face, pruritus, fever and lymphadenopathy have been reported with the use of ARESTIN. Some of these reactions were serious. Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with oral minocycline, as well as acute photosensitivity reactions. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN. Tetracyclines, including oral minocycline, have been associated with development of autoimmune syndromes including a lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy and malaise. In symptomatic patients, diagnostic tests should be performed and ARESTIN treatment discontinued. The use of ARESTIN in an acutely abscessed periodontal pocket or for use in the regeneration of alveolar bone has not been studied. The safety and effectiveness of ARESTIN has not been established in immunocompromised patients or in those with coexistent oral candidiasis. Use with caution if there is a predisposition to oral candidiasis. In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome, and pain. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or . Click here for full Prescribing Information. About ARESTIN ARESTIN® is an FDA-approved antibiotic applied locally to gum pockets in adults with periodontitis following an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines. In 2001, a pivotal study was conducted to: 1) determine whether the administration of minocycline microspheres would enhance the therapeutic effect of scaling and root planing in patients with chronic periodontitis, and 2) determine whether the compound was safe and well tolerated. Seven hundred forty-eight (748) patients with moderate to advanced periodontitis were enrolled in an investigator-blind, multi-center trial and randomized to 1 of 3 treatment arms: 1) scaling and root planing (SRP) alone; 2) SRP plus vehicle; or 3) SRP plus minocycline microspheres. The primary outcome measure was probing depth reduction at 9 months. Clinical assessments were performed at baseline and 1, 3, 6, and 9 months. Minocycline microspheres plus scaling and root planing provided substantially more probing depth reduction than either SRP alone or SRP plus vehicle. The difference reached statistical significance after the first month and was maintained throughout the trial. The improved outcome was observed to be independent of patients' smoking status, age, gender, or baseline disease level. There was no difference in the incidence of adverse effects among treatment groups. About Periodontitis Risks According to the National Health and Nutrition Examination Survey (NHANES), 42.2% of United States adults have periodontitis. There are certain factors that increase the risk for developing gum disease which include smoking, diabetes, poor oral hygiene, obesity and diabetes. In addition, gum disease may provide a gateway for bacteria to enter the body and trigger systemic health issues and inflammation in the body, though further research is necessary. About OraPharma OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded more than 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease and multiple regenerative solutions for oral surgery. More information can be found at . About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Investor Contact: Mark Maico ir@bauschhealth.com (908) 541-2102 (877) 281-6642 (toll free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785 SOURCE: Bausch Health Companies Inc. View source version on accesswire.com:

Rise in adoption of minimally invasive non-surgical procedures in the management of periodontitis in adults is likely to drive the global periodontal treatment market Asia Pacific market is anticipated to witness substantial rise in revenue during the forecast period WILMINGTON, Del., Jan. 4, 2023 /PRNewswire/ -- Increase in focus of people on oral health and high prevalence of periodontal diseases among the global population are likely to propel periodontal treatment market growth. Governments are offering funding for development of innovative medical devices in dentistry, which is likely to broaden periodontal treatment market outlook. The periodontal treatment market size stood at US$ 7.6 Bn in 2021. Advancements in non-surgical periodontal therapy is set to present attractive opportunities to companies in the periodontal treatment market. Associated risk factors of periodontitis are sedentary lifestyle, unhealthy diet, and tobacco consumption. An understanding of these factors has helped healthcare providers decide the extent of the management required in various forms of periodontitis. High prevalence of chronic periodontitis in adults is expected to create attractive business opportunities for companies in the market. Get Exclusive PDF Sample Copy of Periodontal Treatment Market – Key Findings of Study Rise in Demand for Non-surgical Periodontal Therapies: Demand for non-surgical treatments for periodontal diseases has increased significantly in the past few years. The treatments include periodontal scaling & root planning and usage of antibiotics, especially in severe forms of periodontal disease. Advances in pharmacologic therapies are expected to create significant opportunities for companies in the market in the next few years. Patient Preference for Dental Clinics: Dental clinics are the most preferred healthcare setting for the management of periodontal diseases. The segment held major share of the market in 2021. Patients suffering from oral health conditions prefer dental clinics to hospitals. Rise in prevalence of periodontal diseases among adults presents significant untapped opportunities for companies. Incidence of these disease is high in older adults (aged 65 years and above). Adoption of periodontal regeneration therapies has led to increased commercialization of advanced bone graft products, thus fueling market growth. Key Drivers Advancements in the treatment modalities for periodontitis, including adoption of advanced dental bone graft products, is a key driver of the periodontal treatment market. Companies are likely to record higher revenue due to increasing commercialization of bone graft substitutes. Rise in awareness about oral health along with patient-specific risk factors of periodontal diseases is expected to propel market development. These risk factors include smoking and inadequate oral health practices. Furthermore, epidemiologic associations between diabetes mellitus and periodontal diseases presents untapped avenue for companies in the periodontal treatment industry. This is because patients with diabetes mellitus are at a greater risk of developing periodontal disease. Ask for References – Regional Growth Dynamics North America held major market share in 2021. Development of novel technologies and rise in R&D in advanced periodontal therapies have fueled market growth in the region in the past few years. The market in Asia Pacific is likely to grow at a rapid pace from 2022 to 2031. High burden of periodontal diseases, especially in Southeast Asia, and rise in prevalence of oral diseases are expected to propel the market in the region. Competition Landscape The global periodontal treatment market in consolidated, with the presence of small number of leading players. These players are restructuring product portfolio and engaging in merger & acquisition in order to consolidate their positions in the market. Prominent companies in the periodontal treatment market are Planmeca Oy, Novartis AG, Medtronic, Karl Schumacher, Dentsply Sirona, Danaher, Carl Martin GmbH, Biolase, Inc., ASA Dental S.p.A, 3M, and Amyndas Pharmaceuticals. Periodontal Treatment Market Segmentation Treatment Type Non-surgical Treatment Scaling & Root Planning Antibiotics Systemic Antibiotics Local Antibiotics Surgical Treatment Pocket Reduction Surgery Soft Tissue Grafts Bone Grafts Others End-user Hospitals Dental Clinics Others Regions Covered North America Latin America Europe Asia Pacific Middle East & Africa Countries Covered U.S. Canada Germany U.K. France Spain Italy Japan China India ASEAN Brazil Mexico GCC Countries Buy this Premium Research Report | Immediate Delivery Available – Modernization of healthcare in terms of both infrastructure and services have pushed the healthcare industry to new heights, Stay Updated with Latest Healthcare Research Reports by Transparency Market Research: Oral Thin Films Market Consumer Genomics Market Acute Migraine Treatment Market Dental Anesthetics Market Ceftriaxone Market Fusion Inhibitors Market Anti-radiation Drugs Market Asthma Treatment Market About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyses information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update - Contact Nikhil Sawlani Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Blog: Email: [email protected] Logo: SOURCE Transparency Market Research

South San Francisco-based Cortexyme, Inc., received a setback in its latest research efforts. The company announced that it received a letter from the U.S. Food and Drug Administration on January 25, placing a full clinical hold on the Investigational New Drug application for lead clinical asset atuzaginstat, which is in development for the treatment of Alzheimer’s disease. Cortexyme said it plans to provide additional updates pending further talks with the FDA. Meantime, on the stock market, shares of Cortexyme dropped sharply in premarket trading Wednesday following the announcement. Company shares, which closed Tuesday at $9.06, fell to $6.47, a drop of 29.6%. The company’s lead program targets an infectious pathogen called P. gingivalis found in the brains of Alzheimer’s patients, and other organs, which is tied to degeneration and inflammation. Following the FDA’s action, Cortexyme is immediately cutting expenses to ensure cash flow through 2024. The company intends to rationalize operations, which will enable continued support for planned clinical milestones. A top priority will be development of its next-generation gingipain inhibitor, COR588, also being investigated in Alzheimer’s disease. The company is completing a Phase 1 study and expects results in the second quarter of 2022. The company also plans to look into strategic alternatives for its coronavirus program and assess possibilities for atuzaginstat outside of the Alzheimer’s indication. In its statement, Cortexyme let investors know that a more detailed update on its project pipeline and expected milestones for 2022 would be forthcoming. In November, Cortexyme presented data from its Phase II/III GAIN trial at the 14th Clinical Trials on Alzheimer's Disease Conference (CTAD). The 643-participant study was the first large trial to test the efficacy of an oral small-molecule targeting P. gingivalis in mild to moderate Alzheimer’s patients. It failed to reach statistical significance in its co-primary cognitive and functional endpoints at the end of treatment across the overall trial population. However, the data did show that treatment with atuzaginstat slowed cognitive decline compared to placebo in participants with Alzheimer’s disease and P. gingivalis infection. “Our ability to identify the right population in historically hard to treat mild to moderate Alzheimer’s patients, along with finding an efficacious dose with a differentiated safety profile, is important progress toward a breakthrough treatment for Alzheimer’s disease,” said Cortexyme Chief Medical Officer Michael Detke, M.D., Ph.D. at the time. Marwan Sabbagh, M.D., FAAN, lead investigator of the GAIN Trial and professor of neurology at the Barrow Neurological Institute, added, “The GAIN Trial achieved several significant advancements for the Alzheimer’s field, first by clinically confirming that P. gingivalis is a key upstream driver of disease progression. Further, the data demonstrated a compelling risk-benefit pro a clinically significant treatment response in an easily identifiable population of patients.” He further stated, “When coupled with the convenience of oral dosing, atuzaginstat offers the potential to fill a huge gap in the underserved mild to moderate Alzheimer’s population in as many as half those patients.” In August 2021, Cortexyme presented data from the same study at the Annual Biomarkers for Alzheimer’s Disease Summit. The data showed evidence of P. gingivalis infection of the central nervous system in trial participants. P. gingivalis is the same bacterial strain that is responsible for chronic periodontitis. Cortexyme CEO and Co-Founder Casey Lynch said at the time, “Today marks a major milestone toward a comprehensive understanding of Alzheimer’s and slowing of disease progression. The evidence from the GAIN trial advances our ability to identify the right patients, impact an upstream target and improve patient outcomes.”