Bioavailability, Clinical Development and Trials

Positive Phase I results for solid dose prescription CBD medicine

Drug Discovery World

DECEMBER 22, 2023

Positive Phase I results for a new solid dose prescription cannabidiol (CBD) demonstrate the tolerability and bioavailability of the drug. Neuroscience drug discovery company Sapient Therapeutics successfully completed Part B of the Phase I trial comparing its CBD therapy SAP021 with Epidiolex.

Medicine

Medicine Bioavailability Clinical Development Trials

Erasca receives fast track designation for glioblastoma therapy

Pharmaceutical Technology

MAY 2, 2023

The orally bioavailable small molecule EGFR inhibitor ERAS-801 demonstrated significant central nervous system (CNS) penetration in animal trials. This newly granted status helps Erasca to facilitate the development and review of ERAS-801, thereby accelerating the therapy’s reach to patients.

Bioavailability

Bioavailability Clinical Development Gene Trials

Orphagen’s ACC therapy receives FDA rare pediatric disease status

Pharmaceutical Technology

JANUARY 17, 2023

OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1). SF-1 is an important transcription factor for adrenal gland growth and development.

Bioavailability

Bioavailability Clinical Trials Clinical Trials Clinical Development

Zerion and Insud to develop Dispersome formulations of drugs

Pharmaceutical Technology

AUGUST 30, 2022

Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs. The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. . All the clinical and other development expenses will be handled by Insud.

Development

Development Drugs Bioavailability Production

Drug developers look at innovative mechanisms to tackle dry eye syndrome

Pharmaceutical Technology

SEPTEMBER 23, 2022

cyclosporine A) is currently at pre-registration stage with the FDA, following results from late-stage clinical trials that demonstrated CyclASol significantly reduced corneal and conjunctival staining, and improved ocular dryness compared with vehicle. Novaliq’s CyclASol (0.1%

Development

Development Drugs Clinical Trials Clinical Trials

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

MARCH 8, 2021

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Trials

Trials In-Vivo Genotoxicity RNA

Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3

pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. Along with knee osteoarthritis, Grünenthal also plans to test resiniferatoxin in other joints affected by the condition.

Drugs

Drugs Bioavailability Trials Clinical Development

Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19.

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

Clinical Trials

Clinical Trials Clinical Trials Bioavailability Trials

NRG announces £16m Series A for IND for Parkinson’s and ALS

pharmaphorum

NOVEMBER 9, 2022

If these mitochondrial therapeutics were to be successful in clinical trials, they would be the first disease-modifying medicine to actually prevent or delay progression of these diseases. Currently, the treatments available only provide management of symptoms of chronic neurodegenerative disorders.

In-Vitro

In-Vitro Bioavailability Medicine Clinical Trials

Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinical trials underscored the favorable tolerability profile of Vevye.

Gene Silencing

Gene Silencing Drug Delivery FDA Approval RNA

World Parkinson’s Day 2023 and Promising Parkinson’s Disease Treatments

XTalks

APRIL 11, 2023

By avoiding the stomach entirely, there is increased bioavailability and more sustained relief from symptoms. ND0612 is currently in Phase III of clinical development and is supported by four years of safety data.

Bioavailability

Bioavailability Genetics Nurses Development

A Complex Chromosomal Abberation Called Adrenoleukodystrophy

Delveinsight

JULY 30, 2020

The pharma players are evaluating their pipeline candidates in different stages of clinical development. A novel, brain penetrant, orally bioavailable and selective PPAR? Adrenoleukodystrophy Pipeline. Adrenoleukodystrophy pipeline therapies comprise Lenti D , leriglitazone , MGTA-456 , MD1003 , OP-101 , SOM1201 and others.

Hormones

Hormones Marketing Gene Trials

Kronos Bio Announces Publication of Preclinical Study Results for Investigational CDK9 Inhibitor KB-0742 in Cell Chemical Biology

The Pharma Data

OCTOBER 21, 2020

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., SAN MATEO, Calif., and CAMBRIDGE, Mass.,

In-Vivo

In-Vivo In-Vitro Bioavailability Clinical Trials

Sosei Heptares’ COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules for Further Development

The Pharma Data

NOVEMBER 19, 2020

These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. Several compounds are being further optimized for preclinical studies. Details can be found at this link.

Development

Development Bioavailability Production Drugs

Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Delveinsight

AUGUST 25, 2020

Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial. The results announced that the spartalizumab combo stumbled in the trial and failed to hit the primary endpoint of investigator-assessed progression-free survival in melanoma.

Trials

Trials Bioavailability Drugs Protein

Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Pharmaceutical Technology

FEBRUARY 13, 2023

By associating molecular properties with in-silico absorption, distribution, metabolism, excretion, and toxicity (ADMET) models, we can significantly increase the robustness of candidate selection, which subsequently reduces the failure rate during clinical trials.

Development

Development In-Vivo Clinical Trials Clinical Trials

Lilly adds to pain pipeline with Asahi Kasei licensing deal

pharmaphorum

JANUARY 29, 2021

Lilly is paying $20 million upfront for exclusive rights to AK1780, a P2X7 receptor antagonist in early-stage clinical development for neuroinflammatory pain conditions, outside Japan and China. While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable.

Licensing

Licensing Licensing Bioavailability Antibody

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

OCTOBER 25, 2022

Dosing is not left up to physicians; it is built into the FDC product and based on clinical trial results. Furthermore, compared to the cost of developing a new API, substantial savings can be realised when developing an FDC comprised of previously approved new chemical entities or their generic counterparts.

Manufacturing

Manufacturing Production Packaging Packaging

Clinical Research Informer

Positive Phase I results for solid dose prescription CBD medicine

Erasca receives fast track designation for glioblastoma therapy

Trending Sources

Orphagen’s ACC therapy receives FDA rare pediatric disease status

Zerion and Insud to develop Dispersome formulations of drugs

Drug developers look at innovative mechanisms to tackle dry eye syndrome

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3

Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19.

NRG announces £16m Series A for IND for Parkinson’s and ALS

Vevye: A New Cyclosporine Solution for Dry Eye Disease

World Parkinson’s Day 2023 and Promising Parkinson’s Disease Treatments

A Complex Chromosomal Abberation Called Adrenoleukodystrophy

Kronos Bio Announces Publication of Preclinical Study Results for Investigational CDK9 Inhibitor KB-0742 in Cell Chemical Biology

Sosei Heptares’ COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules for Further Development

Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Lilly adds to pain pipeline with Asahi Kasei licensing deal

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

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