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Bio-Path Holdings Provides 2024 Clinical and Operational Update

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화요일, 4월 2, 2024

HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.

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HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.
Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients.
Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing.
In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial.

Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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목요일, 3월 21, 2024

RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update.

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R&D expenses for the quarter ended December 31, 2023 were $23.7 million, compared to $7.8 million for the quarter ended December 31, 2022.
G&A expenses were $4.0 million for the quarter ended December 31, 2023, compared to $2.2 million for the quarter ended December 31, 2022.
Total other income, net was $3.3 million for the quarter ended December 31, 2023, compared to $0.9 million for the quarter ended December 31, 2022.
Net loss was $24.4 million for the quarter ended December 31, 2023, compared to $9.1 million for the quarter ended December 31, 2022.

International Harrington Prize Awarded to Dr. Arlene Sharpe

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화요일, 3월 19, 2024

CLEVELAND, March 19, 2024 /PRNewswire/ -- The eleventh annual Harrington Prize for Innovation in Medicine has been awarded to Arlene H. Sharpe, MD, PhD, Kolokotrones University Professor and Chair of the Department of Immunology at Harvard Medical School. The award recognizes her breakthrough discoveries in immune regulation, which have established foundational principles in immunology and led to new cancer therapies that act by boosting the immune response to cancer.

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CLEVELAND, March 19, 2024 /PRNewswire/ -- The eleventh annual Harrington Prize for Innovation in Medicine has been awarded to Arlene H. Sharpe, MD, PhD, Kolokotrones University Professor and Chair of the Department of Immunology at Harvard Medical School.
Her work helped identify key pathways that restrain the activity of T lymphocytes (immune cells) to fight cancer.
A committee composed of members of the ASCI Council and the Harrington Discovery Institute Scientific Advisory Board reviewed nominations from leading academic medical centers globally before selecting the 2024 Harrington Prize recipient.
2023: Jean Bennett, MD, PhD, and Albert M. Maguire, MD, for their groundbreaking translational research to restore sight in inherited genetic diseases.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

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수요일, 2월 14, 2024

Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points:

Reflection paper on investigations of pharmacokinetics in
the obese population
Table of contents
1.
References .............................................................................................. 9
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016

Page 2/12

1.
This is considered
a shortcoming that is potentially compounded by obese patients often being poorly represented in
clinical studies.
The specific aims of this reflection paper are to:
?
describe how the effects of obesity can be investigated during clinical medicinal product
development.
?
provide recommendations on when investigations of the effect of obesity on the PK of a
medicinal product should be particularly considered.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 3/12

?

discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
recommendations.
Absorption
Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
and transdermal routes in obese subjects.
Distribution
The distribution of medicinal products is driven by body composition, regional blood flow and binding to
tissue and plasma proteins.
Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
degree of ionization) influence its distribution in the body.
In BMI class III obese
subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
lean subjects (4).
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 4/12

An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
reported in obese individuals.
Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
being proportional to the degree of obesity.
In some cases, in particular for CYP3A4 metabolized medicinal products,
bodyweight normalized clearance can be lower in obese patients (23).
Based on presently available data, it has been suggested that uptake transporters
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016

Page 5/12

are downregulated while efflux transporters may be upregulated (31).
Platelet hyper-reactivity is also observed,
which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 6/12

3.

the medicinal product properties and scientific literature indicate that obesity may lead to a
marked effect on elimination and/or distribution or on the PK/PD relationship.
These
models may aid in extrapolating the known efficacy and safety in the non-obese population to the
obese population.
The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
Before and One Year After Bariatric Surgery.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
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41.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 12/12

Skye Bioscience Announces $50.25 Million Private Placement Equity Financing

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월요일, 1월 29, 2024

Financing co-led by a leading life science investor and 5AM Ventures expected to fully fund obesity Phase 2 trial assessing nimacimab, Skye's differentiated peripheral CB1 inhibitor, in combination with a GLP-1R agonist

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Gross proceeds from the PIPE are expected to be $50.25 million, before deducting any placement agent fees and offering-related expenses.
The PIPE financing is expected to close on January 31, 2024, subject to the satisfaction of customary closing conditions.
The PIPE financing was co-led by a life sciences-focused investor and 5AM Ventures, with participation from Ally Bridge Group, Sphera Healthcare, Altium Capital, Driehaus Capital Management and other institutional investors.
Piper Sandler is acting as the lead placement agent and Oppenheimer & Co. is acting as a placement agent for the PIPE financing.

Mineralys Therapeutics Further Defines Endotype-Specific, Targeted Approach to Treatment of Uncontrolled or Resistant Hypertension with Lorundrostat Data at AHA Scientific Sessions 2023

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토요일, 11월 11, 2023

Chronic kidney disease, Blood pressure, Hypertension, Therapy, AHA, BP, Patient, CKD, Obesity, American Heart Association, Aldosterone, Leptin, BMI, Risk, Poster, Target, Pharmaceutical industry

RADNOR, Pa., Nov. 11, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today presented data from the Target-HTN Phase 2 trial that further defines an endotype-specific targeted approach for treating uncontrolled or resistant hypertension with lorundrostat, a highly selective aldosterone synthase inhibitor. The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th –13th.

Key Points:

The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th –13th.
Data previously presented from Target-HTN showed that elevated body mass index (BMI) was predictive of an enhanced reduction in systolic blood pressure (BP) from lorundrostat treatment.
Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for uncontrolled or resistant hypertension.
The poster at AHA Scientific Sessions 2023 titled, “Lorundrostat for Treatment of Obesity-Related, Aldosterone-Dependent Hypertension - An Endotype-Specific, Targeted Approach to the Treatment of Uncontrolled Hypertension,” can be accessed on the publications page of the Mineralys corporate website.

Biohaven Presents Preclinical Data Demonstrating Taldefgrobep alfa Reduces Fat and Improves Lean Mass at The Obesity Society's Annual Meeting, ObesityWeek®

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월요일, 10월 16, 2023

NEW HAVEN, Conn., Oct. 16, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), announced the presentation of preclinical data demonstrating the ability of taldefgrobep alfa to significantly reduce fat mass while increasing lean mass in an obese mouse model. Separately, data supporting the correlation between change in waist circumference and change in total body weight among adults living with overweight and obesity treated with approved anti-obesity medications were reported. Both sets of data were presented on October 15, 2023 at The Obesity Society's annual ObesityWeek conference held in Dallas, TX.

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- Taldefgrobep monotherapy significantly reduced fat and increased lean muscle mass in an obese mouse model; potential body composition changes relevant to individuals living with overweight and obesity.
NEW HAVEN, Conn., Oct. 16, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), announced the presentation of preclinical data demonstrating the ability of taldefgrobep alfa to significantly reduce fat mass while increasing lean mass in an obese mouse model.
Both sets of data were presented on October 15, 2023 at The Obesity Society's annual ObesityWeek conference held in Dallas, TX.
Taldefgrobep's differentiated mechanism offers the potential for a meaningful reduction in fat mass, the primary pathogenic tissue in obesity, while increasing lean mass.

Ozempic is in the spotlight but it's just the latest in a long and strange history of weight-loss drugs

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화요일, 8월 8, 2023

That’s been the holy grail of weight-loss ever since 19th century English undertaker and weight-loss celebrity William Banting’s 1863 Letter on Corpulence spruiked his “miraculous” method of slimming down.

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That’s been the holy grail of weight-loss ever since 19th century English undertaker and weight-loss celebrity William Banting’s 1863 Letter on Corpulence spruiked his “miraculous” method of slimming down.
Since then, humans have tried many things – diet, exercise, psychotherapy, surgery – to lose weight.
But time and again we return to the promise of a weight-loss drug, whether it’s a pill, injection, or tonic.

Ozempic is a recent arrival

Ozempic and its sister drug Wegovy, both manufactured by Novo Nordisk, are the latest offerings in a long history of drug treatments for people who are overweight.
This has helped drive a shortage of Ozempic for diabetes treatment.

From ‘gland treatment’ to amphetamines

For example, organotherapy (gland treatment) was hugely popular in the 1920s to 1940s.
Doctors prescribed overweight people extracts of animal glands – either eaten raw or dried in pill form or injected – to treat their supposedly “sluggish glands”.
Amphetamines were first used as a nasal decongestant in the 1930s, but quickly found a market for weight-loss.
Amphetamines too, fell from treatment use in the 1970s with Nixon’s “war on drugs” and recognition they were addictive.

Another decade, another drug

For example, the popular diet drug of the 1980s and 90s was fen-phen, which contained appetite suppressants fenfluramine and phentermine.
And as history recognises, multiple complexities can combine to push a drug into popularity or damn it to history’s rubbish bin.
One noticeable contrast with past diet drug experiences is that now, many people are happy to talk about using Ozempic.
It seems to be increasingly socially acceptable to use a drug to achieve weight-loss for primarily aesthetic reasons.

Our enduring search for weight-loss drugs

Ozempic is predicted to earn Novo Nordisk US$12.5 billion this year alone, but it’s not just industry interests stoking this enduring desire for weight-loss drugs.
Patients on an endless cycle of dieting and exercise want something more convenient, with a more certain outcome.
It is no wonder demand for weight-loss drugs continues to soar.

The obesity epidemic is fuelled by biology, not lack of willpower

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일요일, 7월 23, 2023

Through most of human history, our species has had to cope with food scarcity.

Key Points:

Through most of human history, our species has had to cope with food scarcity.
When food was abundant, our bodies stored excess energy in the form of fat to draw upon when food was not available.

Ancient metabolism in a modern world

Our brains enabled our species to develop an easier, more comfortable life and a steady supply of food to support population growth.
Later, they invented machines to move ourselves and our belongings from place to place, and life became even easier.
Today, mountains of calorie-rich (and often nutritionally poor) food and lakes of sugary beverages are readily available in much of the world.

The brain’s role in obesity

For far too long society has treated obesity as a personal failing while in reality it’s a biological, physiological, environmental, chronic disease.
The fact is that for many, trying to lose excess fat is very difficult without help.
People living with obesity may have a genetic predisposition toward a heightened reward system associated with food.
Glossy packaging, aggressive marketing (often targeting children), delicious but nutrient-poor foods, drive-through windows and online delivery services all enable this.

Effective treatment

That begins with accepting that polygenic obesity is a disease and not a matter of willpower.
Rather than blaming and shaming one another for our size, we should be more understanding and educate ourselves about obesity, to help take stigma and judgment out of the equation.
It’s important to recognize that when obesity does impair one’s health, it needs treatment, and effective treatment is available.
She has participated in the development and delivery of continued medical education with pharmaceutical companies who have obesity medications including Novo Nordisk and Eli Lilly.

No, you can't blame all your health issues on 'high cortisol'. Here's how the hormone works

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월요일, 5월 1, 2023

Maybe you’re fatigued and can’t concentrate, then wake up in the middle of the night.

Key Points:

Maybe you’re fatigued and can’t concentrate, then wake up in the middle of the night.
The latest TikTok wellness trend would have you believe high cortisol levels are to blame.
But so do thyroid hormones, appetite hormones and sex hormones, as well as diet and physical activity.

Why is cortisol portrayed as bad?

Some of what is being blamed on cortisol are symptoms of chronic stress or depression – which makes sense, since these are linked.
This might make people think cortisol is bad for them, but this is not the case.

Cortisol is essential for a healthy stress response

In a healthy and normal stress response, cortisol rises quickly in response to the stress and then rapidly reduces back to baseline levels after the stress has passed.
Chronic stress can cause dysregulated cortisol secretion: when cortisol remains high even in the absence of an immediate stress.
It can take weeks for cortisol dysregulation to return to normal after chronic stress.

What’s the link with depression?

Our research team has shown that people with depression have, on average, higher cortisol than people who don’t have depression.
The symptoms described on TikTok as being due to high cortisol may be caused by stress, depression or anxiety.
Low cortisol can be caused by chronic stress and high cortisol during childhood or earlier in life.
This is why some people with depression, particularly those with a long history of depression, have low rather than high cortisol.

How do you know if your cortisol is too high or low?

Cortisol affects your body clock

One of the most important roles of cortisol is in the circadian system of the body.
Cortisol communicates these signals from the brain to the rest of the body.

How can you maintain healthy cortisol levels?

You can try to maintain healthy levels of cortisol by addressing the underlying causes of cortisol dysregulation.
Exercise during the day and good sleeping habits also help to reduce chronic stress and high cortisol.