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Oral Dosing Articles & Analysis

24 news found

Biopharma Stock News Bite - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) Spikes on News Potential Treatment for Alcohol Use Disorder

Biopharma Stock News Bite - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) Spikes on News Potential Treatment for Alcohol Use Disorder

According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse ...

ByInvestorideas.com


Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

” Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, no currently available medications offer a single oral dose that provides patients entire active-day efficacy. This Phase 3 trial is being conducted in an Adult Laboratory Setting (ALS) which has been used extensively ...

ByCingulate


Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

(“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD). ...

ByInversago Pharma


Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

The Phase 1 study met all of its primary and secondary endpoints; in all subjects dosed with STAR-LLD, the plasma lenalidomide concentration (AUC) was 57% lower with STAR-LLD continuous subcutaneous (SC) delivery compared to once-daily Revlimid oral delivery. ...

ByStarton Therapeutics


Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics

Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics

Rani Therapeutics Holdings, Inc. recently announced the development of a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule. ...

ByRani Therapeutics


Starton Therapeutics Announces Approval to Proceed with Final Dose Escalation in Phase 1 Clinical Study Evaluating STAR-LLD

Starton Therapeutics Announces Approval to Proceed with Final Dose Escalation in Phase 1 Clinical Study Evaluating STAR-LLD

Eight subjects in the first two cohorts received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period. “The Phase 1 study evaluated STAR-LLD bioavailability, safety, and pharmacokinetics,” said Jamie Oliver. ...

ByStarton Therapeutics


Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

The AURORA 2 study assessed long-term safety and tolerability of voclosporin compared to placebo (both taken in combination with mycophenolate mofetil (MMF) and low-dose oral steroids) in patients with LN receiving treatment for an additional 24 months following completion of one year on treatment in the AURORA 1 study. ...

ByAurinia Pharmaceuticals Inc.


Inversago Pharma presents data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

Inversago Pharma presents data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

In particular, there was a marked, dose-dependent reduction in albuminuria in this model of diabetes and associated kidney injury. ...

ByInversago Pharma


Locus Biosciences Announces $35 Million Financing

Locus Biosciences Announces $35 Million Financing

In addition, funds will support the expansion of Locus’ discovery platform engine and enhancement of its in-house manufacturing capability to support oral solid dose delivery of its products. “Locus’ novel scientific approach has the potential to fundamentally change the way bacterial diseases are treated. ...

ByLocus Biosciences, Inc.


Starton Therapeutics Provides Update on STAR-LLD Lenalidomide Clinical Program

Starton Therapeutics Provides Update on STAR-LLD Lenalidomide Clinical Program

Four subjects in the first cohort received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period. The Independent Data Monitoring Committee reviewed the totality of the safety data from the first cohort and recommended advancement to Part B, where subjects will receive the second-highest of three ...

ByStarton Therapeutics


Report On Activities For The Quarter Ended 31 March 2022

Report On Activities For The Quarter Ended 31 March 2022

The latest data, reported on 17 March 2022, demonstrated that BIT225 protected against COVID related death in K18 transgenic mice (a strain generated to be infectable with SARS-CoV-2, resulting in severe COVID) that were infected with a lethal dose of the virus. Control mice that were not dosed with BIT225 all died by Day 8 post-infection with SARS-CoV-2 from ...

ByBiotron Limited


Jubilant Therapeutics Inc. reports isoform-selective PAD4 inhibitors demonstrating high In Vitro selectivity and potency and In Vivo oral bioavailability and anti-tumor activity

Jubilant Therapeutics Inc. reports isoform-selective PAD4 inhibitors demonstrating high In Vitro selectivity and potency and In Vivo oral bioavailability and anti-tumor activity

Jubilant Therapeutics Inc’s drug discovery platform created a number of lead molecules with b in vitro potency and high selectivity to PAD4 compared to PAD1, PAD2 or PAD3. Oral dosing with a mouse breast cancer model resulted in approximately 50% tumor growth inhibition versus approximately 35% with anti-PD1 antibody and was well tolerated. ...

ByJubilant Therapeutics Inc.


Anavex Life Sciences and Ariana Pharma present positive phase II clinical and biomarker data at the AD/PD 2022 International Conference

Anavex Life Sciences and Ariana Pharma present positive phase II clinical and biomarker data at the AD/PD 2022 International Conference

MDS-UPDRS Total score improved significantly for patients treated with ANAVEX®2-73 high oral once-daily dose compared to placebo. The improvement is clinically relevant, corresponding to a relative improvement of 18.9% over 14 weeks. ...

ByAriana Pharma


Lupin Signs Promotional Agreement with Exeltis on SOLOSECĀ® expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

Lupin Signs Promotional Agreement with Exeltis on SOLOSECĀ® expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

About SOLOSEC SOLOSEC (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.1-4 SOLOSEC is designed to be easy to take and one oral ...

ByLupin Limited


World Health Organization Panel Strongly Recommends The Use Of Baricitinib To Treat Hospitalised Patients With COVID-19

World Health Organization Panel Strongly Recommends The Use Of Baricitinib To Treat Hospitalised Patients With COVID-19

In response to the updated WHO guidelines, Professor Vincent Marconi — Professor of Medicine and Global Health at the Emory School of Medicine and leader of the COV-BARRIER trial — commented: “The WHO guidelines reflect the best available evidence, derived from properly conducted multi-centre randomised-controlled phase 3 studies. As baricitinib is oral, ...

ByBenevolent


Oramed Subsidiary Oravax Medical Signs Cooperation and Purchase Agreement for an Initial Pre-Purchase of 10 Million Doses of Oral COVID-19 Vaccines with Tan Thanh Holdings to Commercialize in Southeast Asia

Oramed Subsidiary Oravax Medical Signs Cooperation and Purchase Agreement for an Initial Pre-Purchase of 10 Million Doses of Oral COVID-19 Vaccines with Tan Thanh Holdings to Commercialize in Southeast Asia

Initial pre-purchase of 10 million doses of oral vaccines with a potential deal for further orders worth hundreds of millions of dollars Prospective patient population of approximately 660 million throughout the Association of Southeast Asian Nations Oramed Pharmaceuticals Inc. ...

ByOramed Pharmaceuticals, Inc.


Aurinia Announces Positive Topline Results From the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Adults With Active Lupus Nephritis (LN)

Aurinia Announces Positive Topline Results From the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Adults With Active Lupus Nephritis (LN)

Study demonstrated a favorable risk/benefit profile over a three-year period, with safety comparable to AURORA 1, and sustained efficacy - Topline results show sustained meaningful reductions in proteinuria compared to mycophenolate mofetil (MMF) and low-dose oral corticosteroids alone, the active study control - Similar to the active control, the ...

ByAurinia Pharmaceuticals Inc.


Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

Axial Therapeutics Doses First Subjects in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD)

The subjects received their first dose of either AB-2004 or placebo at CNS Healthcare in Orlando, FL and Optimal Clinical Trials in Auckland, New Zealand, respectively. ...

ByAxial Therapeutics Inc.


Aurinia Announces Updated Interim Results from the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis

Aurinia Announces Updated Interim Results from the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis

Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 continuation study with the same randomized treatment of voclosporin at 23.7 mg twice daily or placebo, in combination with mycophenolate mofetil (MMF) at 1 g twice daily with either no or low-dose oral steroids, for an additional 24 months. A total ...

ByAurinia Pharmaceuticals Inc.


Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder

Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder

Formulated as a powder that can be mixed with food, AB-2004 offers convenient oral dosing for the ASD community. About the AB-2004 Phase 2b Trial The Phase 2b trial is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of AB-2004 in children aged 13 to 17 who have been diagnosed with ASD. The study will ...

ByAxial Therapeutics Inc.

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