Oral medicine

Kymera Therapeutics Presents New Preclinical Data for KT-621, a First-In-Class, Oral STAT6 Degrader at the ATS Annual Meeting

Retrieved on: 
Mercredi, mai 22, 2024
Oral medicine, Patient, Immunoglobulin E, DDW, Lung, Doctor of Philosophy, American Thoracic Society, Cytokine, Eosinophilic esophagitis, Dupilumab, Therapy, Histology, Asthma, Phase 1, STAT6, Chemokine, ATS, TPD, Gastrointestinal disease, Inflammation, Resource, HDM, Annual general meeting, Pharmaceutical industry

WATERTOWN, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced the presentation of additional preclinical data for KT-621, a potent, selective, oral heterobifunctional degrader of STAT6, at the American Thoracic Society (ATS) Annual Meeting in San Diego, California. The featured data demonstrate activity of KT-621 comparable to a saturating dose of the IL-4Rα antibody, dupilumab, in an asthma efficacy model which demonstrated that KT-621 robustly inhibited all the tested cytokines, chemokines, and cell infiltrates involved in TH2 inflammation in asthma. The Company shared additional new histology data showing amelioration of lung remodeling after low, daily oral doses of KT-621 that was comparable to dupilumab. These data highlight the compelling profile of KT-621 as a potential oral treatment for asthma and other TH2 respiratory diseases. Kymera intends to initiate Phase 1 testing for KT-621 in the second half of 2024 and expects data from the Phase 1 trial to be reported in the first half of 2025.

Key Points: 
  • The Company shared additional new histology data showing amelioration of lung remodeling after low, daily oral doses of KT-621 that was comparable to dupilumab.
  • These data highlight the compelling profile of KT-621 as a potential oral treatment for asthma and other TH2 respiratory diseases.
  • In addition, at low daily oral doses, preclinical studies with KT-621 demonstrated near full in vivo STAT6 degradation in disease-relevant tissues that was well-tolerated.
  • Copies of both the ATS and DDW poster presentations are available in the Resource Library section of Kymera's website.

MeiraGTx Reports First Quarter 2024 Financial and Operational Results

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Jeudi, mai 9, 2024
FDA, Research, UCL Business, Weight loss, IND, Oxyntomodulin, Visual acuity, RIX, Oral medicine, American Academy, Brain, STN, Facial muscles, Technology transfer, Janssen Pharmaceuticals, Appetite, BLA, MHRA, Messenger, Subthalamic nucleus, Safety, Diabetes, Insurance, RNA, AAOM, AAV, Dopamine, Obesity, DNA, Autoimmune disease, Motor cortex, Treatment, Pros, GMP, GIP, Clinical trial, File, PSMA, Sale, Radiation, Neurodegenerative disease, DSM-IV codes, Saliva, Health care, Xerostomia, Patient, Riboswitch, Gene, Peptide, Head, PYY, Pharmaceutical industry

LONDON and NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial and operational results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • MeiraGTx anticipates receiving an additional $15 million in near-term milestone payments later in 2024.
  • As of March 31, 2024, MeiraGTx had cash and cash equivalents of approximately $119.2 million and in April 2024, the Company collected $19.7 million in receivables which were due in the first quarter of 2024, effectively increasing the cash balance to $138.9 million.
  • The increase of $0.6 million was due to higher interest rates and cash balances during 2024.
  • Interest expense was $3.3 million for the three months ended March 31, 2024, compared to $3.1 million for the three months ended March 31, 2023.

Madrigal Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

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Mardi, mai 7, 2024
FDA, CFO, EDT, Liver disease, Portola Pharmaceuticals, Safety, Food, Security (finance), Abstract (summary), Marketing, MAA, CHMP, Fatty liver disease, Webcast, Prescription, NASH, Therapy, THR, F2, Oral medicine, Cirrhosis, Patient, EMA, Fibrosis, Committee, Diagnosis, Health, Standard of care, Marketing Authorisation Application, Biotechnology, Food and Drug Administration, Pharmaceutical industry

Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.

Key Points: 
  • Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.
  • Madrigal is focused on the approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of specialist physicians.
  • The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was published in The New England Journal of Medicine in February 2024.
  • At 8 a.m. EDT today, May 7, 2024, the Company will host a webcast to review its financial and operating results and provide a general business update.

Norcross Complete Dentistry is Opening Doors to Patients, Providing Exceptional Dental Care with a Personal Touch

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Mercredi, mai 1, 2024
Oral medicine, University, Patient, Dental care, Dentistry, OKU, University of Illinois Urbana-Champaign, Communication, Trust, DMD, Environment, Family, Professional, American Dental Association, Multimedia, Health, Omicron Kappa Upsilon

PEACHTREE CORNERS, Ga, May 1, 2024 /PRNewswire-PRWeb/ -- Norcross Complete Dentistry is thrilled to announce the grand opening of their office on May 1st, 2024. At Norcross Complete Dentistry, they believe in the power of personalized experiences with the goal of creating a warm and welcoming environment where patients feel at ease. The team is committed to delivering exceptional service and outstanding results, ensuring that every patient leaves the office with a healthy and confident smile. The clinic delivers a broad spectrum of dental care that ensures maximum comfort, including general, cosmetic, restorative and emergency dentistry, along with specialized pediatric dental services for younger patients. Utilizing the latest in dental technology, the team offers efficient, precise and innovative treatments, including 3D cone beam imaging, TRIOS 3Shape® and iTero Intraoral scanners. By combining cutting-edge technology with a compassionate approach, the practice aims to exceed patient expectations and provide the highest quality of care. Trust and transparency are key at Norcross Complete Dentistry, and the clinic offers clear communication about treatment plans and pricing, ensuring no surprises for valued patients. The practice accepts a diverse range of dental insurance plans from numerous companies, making it easier for patients to receive the dental care they need without financial strain.

Key Points: 
  • PEACHTREE CORNERS, Ga, May 1, 2024 /PRNewswire-PRWeb/ -- Norcross Complete Dentistry is thrilled to announce the grand opening of their office on May 1st, 2024.
  • The clinic delivers a broad spectrum of dental care that ensures maximum comfort, including general, cosmetic, restorative and emergency dentistry , along with specialized pediatric dental services for younger patients.
  • More about Norcross Complete Dentistry:
    Known for unmatched patient care, Norcross Complete Dentistry is a top-rated dental practice in Peachtree Corners, dedicated to fulfilling all types of dental needs.
  • Dr. Kavuri focuses on comprehensive dental care for the entire family and strives to provide quality dental care for adults and children.

Sania Therapeutics presents latest from AAV gene therapy platform at the American Society of Gene & Cell Therapy Annual Meeting

Retrieved on: 
Mardi, avril 23, 2024
Spasticity, Systemic disease, Date, Safety, Abstract (summary), Tropism, Abstract, Microfluidics, Outline, Cell, AAV, Oral medicine, Gene, Society, IPSC, DSM-IV codes, Brain cell, Neuron, Annual general meeting, Therapy, Vaccine

Andy Murray, Ph.D, CEO & Co-Founder of Sania Therapeutics, said: “Since our official launch last May, we have been pressing ahead with developing truly differentiated AAV gene therapies.

Key Points: 
  • Andy Murray, Ph.D, CEO & Co-Founder of Sania Therapeutics, said: “Since our official launch last May, we have been pressing ahead with developing truly differentiated AAV gene therapies.
  • Sania’s approach, using its R-Scan platform, is focused on generating novel, targeted vectors that can be successfully and rapidly translated into the clinic.
  • It combines human induced pluripotent stem cell derived cell types and microfluidics to perform directed AAV capsid evolution in an in vitro human system.
  • It combines an intramuscular injection of AAV gene therapy with oral medicine to selectively reduce excitability in targeted motor neurons.

MeiraGTx Announces Oral Presentation at the 2024 American Academy of Oral Medicine (AAOM) Annual Conference

Retrieved on: 
Jeudi, avril 18, 2024
Oral medicine, American Academy, Poster, Safety, Radiation, Month, PRO, CFB, Xerostomia, Conference, Treatment, Gene, Head, Parotid gland, Pharmaceutical industry

LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL.

Key Points: 
  • LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL.
  • We assessed the safety and efficacy of AAV2-hAQP1 gene therapy as a treatment for this condition.
  • Twenty-four participants with Grade 2/3 xerostomia at least five years after completing radiotherapy (2 years if HPV+) were enrolled in this multi-center, open-label, dose-escalation study.
  • The presentation will be available on the Posters and Publications page of the Company’s website after the respective presentation session has concluded.

Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting

Retrieved on: 
Jeudi, mars 14, 2024
Blood pressure, Sinai Hospital, Anaphylaxis, Absorption, Angioedema, Plasma, Type, PD, Patient, Heart rate, Adrenaline, NDA, Epinephrine autoinjector, Cmax, Trial of the century, Mouth, Therapy, Safety, Oral medicine, Allergy, Vomiting, Swelling, FDA, Study, Food, Pharmaceutical industry

“We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive.

Key Points: 
  • “We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive.
  • “We believe we have a clear understanding of the remaining clinical development steps necessary for a pre-NDA meeting with the FDA in the second half of the year.
  • These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments.
  • The FDA noted that substantial progress had been made in the Anaphylm clinical development program and did not outline any new clinical development requirements.

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Samedi, février 24, 2024
BTK, QPM, BID, AAAAI, Week, Omalizumab, TID, News, Prurigo nodularis, Asthma, Swelling, IgG4-related disease, Skin, Oral medicine, UAS7, Patient, CSU, Disease, Itch, LSM, ITT, American Academy, Pharmaceutical industry

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Areteia Therapeutics Announces Appointment of Daniel Becker, M.D., Ph.D. To Board of Directors

Retrieved on: 
Jeudi, février 15, 2024
Chemicals, Plastics, Clinical Trials, Manufacturing, Biotechnology, Alternative Medicine, Health, Pharmaceutical, Other Science, Science, Boston, Champaign–Urbana metropolitan area, Health care, University, Multimedia, Hospital, Access, Boston Consulting Group, Molecular biology, Cellular, Oral medicine, Therapy, Patient, Internal medicine, Massachusetts General Hospital, Phase, Harvard Medical School, Nephrology

Areteia Therapeutics, Inc. (“Areteia”) today announced the appointment of Daniel Becker to the Areteia Board of Directors, effective immediately.

Key Points: 
  • Areteia Therapeutics, Inc. (“Areteia”) today announced the appointment of Daniel Becker to the Areteia Board of Directors, effective immediately.
  • Dr. Becker will serve as a member of the audit committee of the board.
  • View the full release here: https://www.businesswire.com/news/home/20240215803782/en/
    “I am excited that Dan has been appointed to our board,” said Jorge Bartolome, President and Chief Executive Officer of Areteia.
  • and Ph.D. (Cellular and Molecular Biology) degrees from the University of Michigan and received his B.S.

Alarming Study Reveals Safety Limits are Exceeded for Mercury Exposure from Dental Amalgams in Pregnant Women in the U.S.

Retrieved on: 
Mercredi, février 14, 2024
Woman, Oral medicine, Alzheimer's disease, NHANES, Pregnancy, National Health, FDA, Dentist, International Academy, Risk, Multiple sclerosis, Safety, Health, Menopause, Parkinson's disease, Patient, DSM-IV codes, Policy, Mercury, Research, Composite, Gold

This study presents groundbreaking findings on the mercury vapor exposure from dental amalgams of pregnant women in the United States.

Key Points: 
  • This study presents groundbreaking findings on the mercury vapor exposure from dental amalgams of pregnant women in the United States.
  • In women with amalgam surfaces, the number of surfaces, correlated with significantly higher median daily urinary mercury excretion compared to women without amalgams.
  • Notably, close to 30% of these women received daily mercury vapor doses from amalgams exceeding the safety limits set by the U.S. Environmental Protection Agency.
  • Mercury amalgam dental fillings should be banned by the FDA as they pose a serious risk to the health of all individuals who have amalgam fillings, especially pregnant women and those of reproductive age."