作者: Bernstein, Galina ; Lala, Anuradha ; Esque, Benjamin ; Adler, Eric ; Kapur, Navin K. ; Kolski, Brian ; Neutel, Joel ; Ambrosy, Andrew P. ; Bensimhon, Daniel

2025-01-29·Open Forum Infectious Diseases

571. Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age

作者: Neutel, Joel ; Erdem, Rahsan ; Koury, Kenneth ; Munjal, Iona ; Swanson, Kena A ; Gurtman, Alejandra C ; Cannon, Kevin ; Newton, Ryan ; Mensa, Federico ; Tureci, Ozlem ; Jiang, Qin ; Kitchin, Nicholas ; Anderson, Annaliesa S ; Stacey, Helen ; Sahin, Ugur ; Cooper, David ; Gomme, Emily A ; Li, Wen

AbstractBackgroundOlder adults are vulnerable to both severe COVID-19 and RSV illness. Coadministration of RSV and COVID-19 vaccines could reduce healthcare visits for this population and potentially improve vaccine uptake. This study evaluated safety, tolerability, and immunogenicity of RSV and COVID-19 vaccines given together with or without seasonal quadrivalent influenza vaccine (QIV) as part of a larger clinical study looking at combination vaccines.MethodsThis phase 1/2 randomized study (NCT05886777) included healthy ≥ 65-year-olds who had received ≥ 3 previous mRNA COVID-19 vaccine doses (the most recent a bivalent vaccine given ≥ 150 days before study vaccine). In this study part, participants received coadministered RSVpreF and bivalent BA.4/BA.5-adapted BNT162b2 vaccine (RSVpreF/BNT162b2) with QIV or placebo; RSVpreF; BNT162b2; or QIV. Immunogenicity objectives included demonstration of noninferiority of neutralizing antibody titers elicited by RSVpreF/BNT162b2 compared to either vaccine administered alone, and by RSVpreF/BNT162b2 coadministered with QIV compared to RSVpreF, BNT162b2, and QIV alone (Figure 1).ResultsOf 766 participants in this analysis (149–158 per group), 46% were male, 89% White, 9% Hispanic/Latino. Median age was 71 (range 65–90) years. Based on the prespecified 2-fold margin, immune response noninferiority was demonstrated for RSVpreF/BNT162b2 for 2 RSV antigens and 2 SARS-CoV-2 strains versus RSVpreF or BNT162b2 alone (Figure 2). Noninferiority was also demonstrated for all 8 antigens (2 RSV; 2 SARS-CoV-2; 4 influenza) for immune responses elicited by RSVpreF/BNT162b2 administered with QIV versus those with RSVpreF, BNT162b2, or QIV alone (Figure 3). RSVpreF/BNT162b2 was well tolerated with mostly mild/moderate reactogenicity with rates generally similar across groups (Figure 4). Adverse events (AEs) were infrequent, mostly mild/moderate, and occurred at similar frequencies across groups. No AEs led to study withdrawal, and no serious AEs were considered vaccine related.ConclusionIn ≥ 65-year-olds, RSVpreF/BNT162b2 was safe and well tolerated, including when coadministered with QIV. The data support that RSVpreF and BNT162b2 can be administered concomitantly, which may support improved uptake of both vaccines.Funding: Pfizer Inc.DisclosuresJoel Neutel, MD, Pfizer Inc: Employee Rahsan Erdem, MD, Pfizer Inc: Employee|Pfizer Inc: Stocks/Bonds (Private Company) Qin Jiang, PhD, Pfizer: Salary|Pfizer: Stocks/Bonds (Public Company) Ryan Newton, BSC/MBA, Pfizer Inc: Employee|Pfizer Inc: Stocks/Bonds (Private Company) Emily A. Gomme, Ph.D., Pfizer Inc: Employee|Pfizer Inc: Stocks/Bonds (Private Company) Federico Mensa, MD, BioNTech: Employee|BioNTech: Stocks/Bonds (Public Company) Ozlem Tureci, MD, BioNTech: Employee|BioNTech: Stocks/Bonds (Public Company) Ugur Sahin, MD, BioNTech: Employee|BioNTech: Stocks/Bonds (Public Company) Kena A. Swanson, Ph.D., Pfizer: Employee of Pfizer|Pfizer: Stocks/Bonds (Public Company) Iona Munjal, MD, Pfizer: Salaried employee|Pfizer: Stocks/Bonds (Public Company) David Cooper, PhD, Pfizer, Inc.: Employee|Pfizer, Inc.: Stocks/Bonds (Public Company) Kenneth Koury, PhD, Pfizer Inc: Employee|Pfizer Inc: Stocks/Bonds (Public Company) Annaliesa S. Anderson, PhD, Pfizer, Inc.: Employee|Pfizer, Inc.: Stocks/Bonds (Public Company) Alejandra C. Gurtman, M.D., Pfizer, Inc.: Employee|Pfizer, Inc.: Stocks/Bonds (Public Company) Nicholas Kitchin, MD, Pfizer Inc: Employee|Pfizer Inc: Stocks/Bonds (Public Company)

2024-05-01·Journal of Hypertension

ZILEBESIRAN AS ADD-ON THERAPY IN PATIENTS WITH HYPERTENSION INADEQUATELY CONTROLLED WITH A STANDARD ANTIHYPERTENSIVE MEDICATION: EFFICACY AND SAFETY RESULTS FROM THE KARDIA-2 STUDY

作者: Saxena, Manish ; Park, Wansu ; Badariene, Jolita ; Aswad, Ahmad ; Makarova, Nune ; Kazi, Farhana ; Neutel, Joel M ; Stiglitz, Daniel ; Zappe, Dion ; Havasi, Andrea ; Karns, Adam D ; Bakris, George

Objective:Zilebesiran is an investigational RNA interference therapeutic that targets hepatic angiotensinogen, the most upstream precursor of the renin-angiotensin system. In the Phase 2 KARDIA-1 study, single subcutaneous (SC) doses of zilebesiran monotherapy significantly reduced 24-hr mean ambulatory and office systolic blood pressure (SBP) from baseline to Months 3 and 6 versus placebo. The objective of KARDIA-2, a Phase 2 randomized, double-blind, placebo-controlled study, was to assess efficacy, safety, and pharmacodynamics of zilebesiran in combination with a standard-of-care antihypertensive medication class in patients with uncontrolled hypertension.Design and method:KARDIA-2 enrolled adults with mild-to-moderate hypertension who were untreated or receiving stable therapy with up to two antihypertensives. Patients entered a run-in period, where previous antihypertensives were discontinued, and were subsequently randomized to open-label, once-daily oral olmesartan 20 or 40 mg, amlodipine 5 mg, or indapamide 2.5 mg as background antihypertensive therapy. After at least 4 weeks of run-in, patients with 24-hr mean ambulatory SBP of 130–160 mmHg were randomized 1:1 to single-dose SC zilebesiran 600 mg or placebo as add-on therapy. Escape antihypertensives could be initiated after Month 3 if a patient's SBP met pre-specified escape criteria. However, assessments while patients were on or within two weeks of stopping any escape medication were excluded in analyses. The primary endpoint was change in 24-hr mean ambulatory SBP from baseline to Month 3, assessed as the least-square mean difference between zilebesiran and placebo. Key secondary endpoints were change from baseline to Month 3 in office SBP, time-adjusted change from baseline to Month 6 in 24-hr mean ambulatory and office SBP, and proportion of patients with 24-hr mean ambulatory SBP less than 130 mmHg and/or a reduction of at least 20 mmHg without escape medication at Month 6.Results:KARDIA-2 enrolled 672 patients and is currently ongoing. Primary, secondary, safety, and pharmacodynamic endpoints will be presented at the meeting.Conclusions:KARDIA-2 will provide insights into the potential benefit of adding zilebesiran to patients with hypertension inadequately controlled with standard-of-care antihypertensive monotherapy, building on efficacy and safety learnings from previous Phase 1 and 2 studies of this novel therapeutic strategy.

项与 Orange County Research Center 相关的新闻（医药）

2022-11-15

·GlobeNewswire-Health Care

BioCorRx Provides Business Update for the Third Quarter of 2022

ANAHEIM, CA, Nov. 15, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today provided a business update for the third quarter ended September 30, 2022 and reported on recent corporate developments. Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., commented, “Last month, we reached a significant milestone as we announced that the last subject had been enrolled in the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical stage pharmaceutical company. We are currently in the process of collecting data and we expect to have interim data by the end of the year depending on 3rd party turnaround times. We plan to add additional subjects to complete the FDA-required clinical characterization of BICX104 prior to seeking marketing approval. “Additionally, we saw an increase in revenue in the third quarter of 2022 due to the increased number of patients treated at licensed clinics. Furthermore, we were pleased to see that membership/program fees also increased for the third quarter of 2022 due to more customers signing up for our UnCraveRx™ Weight Loss Management Program. At the same time, we continue to carefully manage expenses and reduced operating expenses by nearly 32%.” The BICX104 clinical study is a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection. The study is led by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center (OCRC), located in Tustin, CA. Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694. BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company has an active Investigational New Drug (IND) status, and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD). A copy of the Company’s annual report on Form 10-Q for the third quarter ended September 30, 2022 has been filed with the Securities and Exchange Commission and posted on the Company’s website at https://ir.biocorrx.com/. About BioCorRxBioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com. Safe Harbor StatementThe information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. BioCorRx Inc. investors@BioCorRx.com 714-462-4880 Investor Relations: Crescendo Communications, LLC 212- 671-1020 x304 bicx@crescendo-ir.com Media ContactPhillComm GlobalBioCorRx@PhillComm.Global704-942-1557

临床1期

2022-10-13

·BioSpace

BioCorRx Completes Final Subject Enrollment in Phase I Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder

ANAHEIM, CA, Oct. 13, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced that the last subject has been enrolled in the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical stage pharmaceutical company. “We are pleased to have reached this significant milestone,” said Brady Granier, President, Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc. “We are currently in the process of collecting data and we expect to have interim data by the end of the year demonstrating safety and duration. We plan to add additional subjects to complete the FDA-required clinical characterization of BICX104 prior to seeking marketing approval potentially in 2023. As the opioid epidemic continues to plague the nation, our purpose is to rapidly bring BICX104 to market and provide a truly effective treatment for those suffering from substance use disorders and their lethal consequences.” The BICX104 clinical study is a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol. The study is led by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center (OCRC), located in Tustin, CA. Information about the study can also be found at under NCT number 04828694. BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company has an active Investigational New Drug (IND) status, and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD). About BioCorRx BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit . Safe Harbor Statement The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. BioCorRx Inc. investors@BioCorRx.com 714-462-4880 Investor Relations: Crescendo Communications, LLC 212- 671-1020 x304 bicx@crescendo-ir.com

合作

2022-08-16

·BioSpace

BioCorRx Provides Business Update for the Second Quarter of 2022

ANAHEIM, CA, Aug. 16, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today provided a business update for the second quarter ended June 30, 2022 and reported on recent corporate developments. Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., commented, “During the quarter, we dosed the first subject in the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical stage pharmaceutical company. This was a major milestone for the Company as our goal is to rapidly bring BICX104 to market to provide an additional life-saving treatment option for those suffering from substance use disorders. We are pleased to report that this month we have enrolled and dosed several more subjects.” “Additionally, we announced that together with our strategic partner, 2B3D, a veteran-owned, virtual, augmented, and mixed reality technology company, we are piloting a first of its kind post-traumatic stress disorder (PTSD) and addiction treatment solution for veterans in a metaverse setting. The synergistic treatment offering combines our comprehensive medication-assisted treatment (MAT), Beat Addiction Recovery Program which includes our proprietary cognitive behavioral therapy (CBT) curriculum and peer support for substance use disorder with 2B3D virtual reality technology. We believe this program will offer veterans suffering with substance abuse and other related disorders an enhanced treatment solution. We look forward to partnering with other veteran groups for our Beat Addiction Recovery Program to aid veterans suffering with substance use disorders.” The BICX104 clinical study is a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection. The study is led by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center (OCRC), located in Tustin, CA. Interested participants can reach out directly to OCRC on their website at . Information about the study can also be found at under NCT number 04828694. BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company has an active Investigational New Drug (IND) status, and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD). A copy of the Company’s annual report on Form 10-Q for the second quarter ended June 30, 2022 has been filed with the Securities and Exchange Commission and posted on the Company’s website at . About BioCorRx BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit . Safe Harbor Statement The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. BioCorRx Inc. investors@BioCorRx.com 714-462-4880 Investor Relations: Crescendo Communications, LLC 212- 671-1020 x304 bicx@crescendo-ir.com

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