Pharmacokinetics

DICE Therapeutics Initiates Phase 1 Clinical Trial of S011806 for the Treatment of Psoriasis

Monday, October 25, 2021 - 1:00pm

The Phase 1 trial of S011806 is designed to generate safety and pharmacokinetic data, as well as provide early clinical proof-of-concept in psoriasis patients.

Key Points: 
  • The Phase 1 trial of S011806 is designed to generate safety and pharmacokinetic data, as well as provide early clinical proof-of-concept in psoriasis patients.
  • The Phase 1 clinical trial is a first-in-human, randomized, double-blind, placebo-controlled study that will evaluate S011806 in healthy volunteers and psoriasis patients in the UK.
  • The trial will evaluate single and multiple ascending doses in healthy volunteers to understand the safety and pharmacokinetics of S011806.
  • In addition, the Phase 1 clinical trial will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of S011806 across two dose regimens in psoriasis patients, which could provide early clinical proof-of-concept and dose selection guidance for use in future studies.

Arrowhead Files for Regulatory Clearance to Begin Phase 1/2a Study of ARO-C3 for Treatment of Complement Mediated Diseases

Monday, October 25, 2021 - 12:30pm

Arrowhead will host a key opinion leader (KOL) webinar on October 26, 2021, at 3:00 p.m.

Key Points: 
  • Arrowhead will host a key opinion leader (KOL) webinar on October 26, 2021, at 3:00 p.m.
  • Chris Anzalone, Ph.D., president and chief executive officer of Arrowhead, said: ARO-C3 utilizes Arrowheads proprietary TRiM platform to silence the hepatic production of complement C3.
  • They will discuss the current treatment landscape and unmet medical need in treating patients with complement mediated renal and hematological diseases.
  • ARO-C3 is designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases.

Proactive news headlines including Perseus Mining, Walkabout Resources, Recce Pharmaceuticals and Great Boulder Resources

Monday, October 25, 2021 - 9:46am

Click here

Key Points: 
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    Great Boulder Resources Ltd (ASX:GBR) has identified a high-priority target immediately south of the current high-grade gold intersections at the Mulga Bill mineralised corridor within the Side Well Gold Project in Western Australia.
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    Aldoro Resources Ltd (ASX:ARN) has sampled a world-class lithium and rubidium pegmatite fairway within its Wyemandoo property in Western Australia.
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    Archer Materials Ltd (ASX:AXE, OTC:ARRXF) has raised A$15 million via its share purchase plan (SPP) which closed on October 20.
  • Proactive has produced over 300,000 articles and 20,000 executive interviews since it was established in 2006
    For more information on how Proactive can help you make a difference, email us at action@proactiveinvestors.com

Beckley Psytech Announces First Cohort Dosed in Phase 1 Clinical Trial Assessing Safety and Tolerability of Intranasal 5-MeO-DMT

Monday, October 25, 2021 - 7:00am

The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and tolerability of a single intranasal dose of 5-MeO-DMT in psychedelic-nave healthy subjects.

Key Points: 
  • The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and tolerability of a single intranasal dose of 5-MeO-DMT in psychedelic-nave healthy subjects.
  • This is the first clinical study to measure the pharmacokinetics and metabolism of 5-MeO-DMT delivered intranasally.
  • Blinded data from the study will be used to inform the planned Phase 2 study dose and design in H1 2022.
  • The study will enrol up to 42 volunteers to evaluate the safety, tolerability, and pharmacokinetics of single ascending intranasal doses of 5-MeO-DMT.

Turning Point Therapeutics Presents Early Clinical Data for Repotrectinib From Care Study in Pediatric and Young Adult Patients at SIOP 2021 Virtual Congress

Saturday, October 23, 2021 - 2:12pm

These data are being presented today at the virtual 53rd Congress of the International Society of Paediatric Oncology (SIOP) being held October 21-24.

Key Points: 
  • These data are being presented today at the virtual 53rd Congress of the International Society of Paediatric Oncology (SIOP) being held October 21-24.
  • These early data for repotrectinib demonstrate encouraging clinical activity in this pediatric patient population, said Mohammad Hirmand, M.D., chief medical officer.
  • The primary objective of the Phase 2 portion of the study is to determine the anti-tumor activity of repotrectinib in pediatric and young adult patients less than 25 years old.
  • The early Phase 1/2 CARE dataset utilizes an August 2, 2021 data cutoff date.

PharmaEssentia Announces Pipeline Presentation During Upcoming American Society of Hematology Annual Meeting

Thursday, October 21, 2021 - 1:30pm

PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced plans to present new updates on its pipeline during the 63rd American Society of Hematology Annual Meeting , December 11-14, 2021.

Key Points: 
  • PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced plans to present new updates on its pipeline during the 63rd American Society of Hematology Annual Meeting , December 11-14, 2021.
  • PharmaEssentia continues to enroll participants in the trial at sites throughout the United States and Asia, and has now expanded with new sites in Canada.
  • We are pleased to partner with these renowned MPN specialists to participate in this important study.
  • PharmaEssentia continues to build momentum with its pipeline to deliver new solutions in MPNs.

Ligand and CR Double-Crane Enter Collaboration Agreement to Develop an Oral COVID-19 Therapeutic Using Ligand’s BEPro Technology™

Thursday, October 21, 2021 - 2:00pm

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical Co., Ltd. (CRDC) exclusive Asia territorial rights to develop a novel investigational oral COVID-19 antiviral therapeutic compound using Ligands BEPro technology.

Key Points: 
  • Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical Co., Ltd. (CRDC) exclusive Asia territorial rights to develop a novel investigational oral COVID-19 antiviral therapeutic compound using Ligands BEPro technology.
  • BEPro is a proprietary prodrug technology that is specifically applicable to nucleotides and nucleotide analogs for the development of compounds with improved product profiles.
  • Ligand has filed multiple patents globally on the BEPro technology and potential antiviral compounds.
  • Ligands OmniAb technology platform is a patent-protected technology stack used in the discovery of fully human mono- and bispecific therapeutic antibodies.

Simulations Plus Announces the University+ Program

Thursday, October 21, 2021 - 1:30pm

The University+ Program offers free one-year access to Simulations Plus software to students and educators at accredited universities worldwide and is renewable provided eligibility conditions are met.

Key Points: 
  • The University+ Program offers free one-year access to Simulations Plus software to students and educators at accredited universities worldwide and is renewable provided eligibility conditions are met.
  • John DiBella , Simulations Plus division president, stated: Simulations Plus has been a staunch supporter of academic research training and collaborations for over two decades to advance the science of Modeling and Simulation (M&S).
  • By providing accredited universities with free access to the Simulations Plus portfolio of software, we will be able to drive M&S learning and understanding prior to entering the workforce.
  • What better way of celebrating our 25th anniversary than by investing in the next generation of scientists, added Shawn OConnor , CEO of Simulations Plus.

Matinas BioPharma Initiates Dosing in Phase 1 Study of Potential First Oral Aminoglycoside Antibiotic Drug MAT2501

Thursday, October 21, 2021 - 12:00pm

MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin.

Key Points: 
  • MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin.
  • Our goal with MAT2501 is to develop the first oral aminoglycoside, which could transform the use of this important class of drugs, stated Jerome D. Jabbour, Chief Executive Officer of Matinas.
  • This Phase 1 study is a double-blind, placebo-controlled, SAD study designed primarily to evaluate the safety, tolerability and pharmacokinetics of single ascending oral doses of MAT2501 in healthy adult subjects.
  • MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections.

reMYND’s ReS19-T program, managing calcium homeostasis for Alzheimer’s, has moved to MAD phase after demonstrating strong safety in SAD phase

Thursday, October 21, 2021 - 12:00pm

The multiple-ascending dose (MAD) phase has been initiated well before the maximum tolerable dose has been reached.

Key Points: 
  • The multiple-ascending dose (MAD) phase has been initiated well before the maximum tolerable dose has been reached.
  • To date, healthy volunteers in the SAD phase have been dosed up to 700 mg, and food impact has been assessed at this high dose.
  • The preclinical studies and early clinical trials of ReS19-T provide a strong foundation for advancing this innovative treatment.
  • With this promising data we are getting close to a pivotal test of the calcium hypothesis in patients in 2022.