Drug Discovery and Development Archives - Page 34 of 158

Terran Biosciences secures intellectual property for psychedelic prodrugs

Terran Biosciences, a neurology and psychiatry-focused startup, has announced the publication of patent applications under the Patent Cooperation Treaty (PCT) for its novel prodrugs of DMT, 5-MeO-DMT and MDMA.

Claim of superior pharmacokinetics

The company believes the prodrugs have superior pharmacokinetic profiles compared to the unmodified forms of these Schedule I substances. Additionally, it believes it can make DMT and 5-MeO-DMT orally active through its proprietary prodrug approach. Visceral monoamine oxidase (MAO), a digestive enzyme, inactivates the drug when taken orally in its standard form.

DMT, the primary psychoactive ingredient in ayahuasca, is traditionally consumed with an MAO inhibitor (MAOI) such as harmine or harmaline. This approach is unlikely to become widely adopted in clinical practice as a result of potential side effects such as nausea, vomiting and blood pressure changes.

Although injectable, inhaled, buccal and sublingual del…

New study suggests link between Moderna COVID-19 booster and chronic hives

[Image courtesy of Pol Maria via Adobe Stock]

A Swiss study found that the monovalent Moderna (Nasdaq:MRNA) COVID-19 booster vaccine may be linked to a higher risk of a type of hives known technically as chronic spontaneous urticaria (CSU).

In a cohort of the study based in the Swiss canton of Vaud, 90% of people who received the mRNA-based Moderna COVID-19 booster and developed new-onset hives had the Moderna vaccine beforehand. In a nationwide cohort, 81% of those with new-onset hives received the vaccine first.

The research was published in JAMA Network Open.

Overview of the Swiss study

The incidence of CSU after a booster dose was 1.9 to 2.1 per 100,000 doses of the Pfizer-BioNTech vaccine and 30.8 to 43.9 per 100,000 doses of Moderna’s product.

The study authors are uncertain why the Moderna COVID-19 booster appears more strongly associated with CSU than the Pfizer-BioNTech vaccin…

FDA greenlights Jesduvroq, which GSK hails as ‘first innovative medicine’ for anemia in three decades

GSK (NYSE:GSK) has received FDA approval for Jesduvroq, an oral oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a daily treatment for anemia associated with chronic kidney disease in adult dialysis patients.

Jesduvroq is the first new medicine for anemia treatment in over 30 years, GSK noted.

The drug is the only HIF-PHI to win FDA approval.

Black box warning

A black box warning, however, may constrain its use. The warning notes that Jesduvroq may lead to an increased risk of death, heart attack and other cardiovascular problems. In addition, the warning notes that the drug may elevate the risk of blood clotting problems and major heart events. The FDA recommends that the drug be used only at the lowest dose to minimize the need for blood transfusions.

Barclays estimated Jesduvroq sales to top out at £364 million ($450 million).

GSK shares ticked down one percentage point to $35.13 after announcing the approval news…

Community oncology groups driving more clinical trials

[Image courtesy of Adobe Stock]

In the U.S., most cancer patients receive care in a community setting, a unique care model that traces its origins back to the original war on cancer. Since then, the National Cancer Institute and other organizations have supported this model of pushing more cancer care to community settings. Community oncology groups are poised to conduct a greater share of clinical trials in the coming years.

The traditional approach to oncology clinical research

Traditionally, clinical trials in cancer have disproportionately been conducted in large academic centers such as the Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, the Dana-Farber Cancer Institute and the Mayo Clinic. These centers are often established as training facilities, according to Jeff Elton, CEO of ConcertAI, with a reimbursement model allowing clinicians to spend equal time on research and patient care.<…

FDA grants GSK’s Benlysta orphan drug designation for systemic sclerosis

GSK (NYSE:GSK) announced that FDA has granted Orphan Drug Designation (ODD) to Benlysta (belimumab) for systemic sclerosis (SSc), a rare autoimmune disease that can affect multiple organs.

Interstitial lung disease (ILD) is the leading cause of death in SSc patients.

The monoclonal antibody Benlysta is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. A soluble ligand belonging to the TNF cytokine family, BLyS is elevated in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. Blocking BLyS decreases the number of abnormal B cells, supporting a reduction in the severity of autoimmune diseases.

GSK shares held steady after announcing the news and Q4 results, dipping 0.20% to $35.19 in mid-day trading.

The company intends to launch a Phase 2/3 study of belimumab for SSc-associated ILD in the first half of 2023.

Benlysta could address an unmet need in systemic sclerosis…

Big Pharma companies trimming pipelines in 2023

[Image courtesy of Adobe Stock]

Several companies, including GSK, Janssen, Novartis and Pfizer, have announced that they are cutting their pipelines as they release their full-year 2022 financial results. The following are the drugs removed from these companies’ pipelines.

Bristol Myers Squibb

Cendakimab: Bristol Myers said it would no longer develop its atopic dermatitis antibody cendakimab, which had completed a Phase 2 study. Although the study met its primary endpoint, the treatment landscape for atopic dermatitis is crowded, and cendakimab does not offer a significant advantage over these existing options, according to the company’s chief medical officer, Samit Hirawat.

GSK

GSK3915393: GSK said in a quarterly earnings call that it had pulled the plug on GSK3915393, an inhibitor of transglutaminase 2 (TG2). The company had believed GSK3915393 held potential for celiac disease. The drugR…

Athira Pharma calls for a fresh approach to treating Alzheimer’s disease

The clinical-stage biopharma Athira Pharma (Nasdaq:ATHA) has published a review paper stressing the need for new treatments for Alzheimer’s disease.

The paper also states that one of its small molecule drugs, fosgonimeton, holds potential for treating Alzheimer’s.

The Journal of Alzheimer’s Disease published the paper titled “The Case for a Novel Therapeutic Approach to Dementia: Small Molecule Hepatocyte Growth Factor (HGF/MET) Positive Modulators.”

ATHA shares were down 1.24% to $3.99 in pre-market trading.

Moving beyond ACT-AD

In June 2022, Athira Pharma revealed disappointing results from the Phase 2 ACT-AD trial focused on Alzheimer’s disease. The study did not show a statistically significant change in ERP P300 latency (a measure of cognitive function) for the modified intent-to-treat population. Fosgonimeton recipients were divided into 40 mg and 70 mg dose groups. Investigators performed a pooled analysi…

Noble Leads with its User-Centered Design Strategy

By Tim McLeroy, Executive Director of Marketing and Patient Services, Noble International

At Noble, the patient journey drives everything we do. Our patient-centered approach pushes us to fully understand and characterize patient needs, providing data and experiences that help us ease the burden and anxiety of self-administered treatments.

While drug delivery devices are well designed to address a general patient population, too often challenges and anxieties that patients experience negatively impact their compliance and adherence to prescribed regimens. The capabilities of users are a cornucopia of aging and/or disease factors that can lead to tremor, diminished hand strength, dexterity & haptic feedback, challenged vision, and compromised cognitive processing. A patient-centered strategy takes all these factors into account to deliver device design & training solutions with effective user experiences.

If patients are to become and rema…

Ymmunobio gets ownership rights to NPTXR antibodies

The biotech Ymmunobio has acquired ownership rights to neuronal pentraxin receptor (NPTXR) antibodies, which could promise in treating several gastrointestinal cancers.

Basel, Switzerland–based Ymmunobio reached an agreement with Nagoya University in Japan in 2022 to transfer rights to the antibodies. Professor Mitsuro Kanda of Nagoya University invented the antibodies.

A 2020 article published in Molecular Cancer noted NPTXR-targeting antibodies may have utility as novel diagnostic tools or treatment modalities for gastric cancer.

The company has selected the YB-800 NPTxR antibody as a candidate for development. Based on in vitro and in vivo testing, YP-800 appears to have anti-tumor activity against solid tumors, including gastro-intestinal and breast cancers.

Ymmunobio’s website notes that it has multiple generations of immune agonistic antibodies targeting Carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1) in development. Anti…

Pfizer tops $100B in revenue in 2022, but expects dwindling COVID-19 vaccine sales

New York City–based Pfizer (NYSE:PFE) announced that its full-year 2022 revenues were $100.3 billion, a record for the company.

Pfizer has more than doubled its revenue compared to 2020 when it generated $42.9 billion in sales. In 2021, its revenue hit $81.3 billion.

But the company will likely have trouble sustaining that momentum, considering its revenues, excluding contributions from its COVID-19 products Paxlovid and Comirnaty, were up just 2% operationally.

In 2022, Paxlovid and Comirnaty drove close to $57 billion, almost 60% of the company’s revenue.

Pfizer anticipates that Comirnaty will generate approximately $13.5 billion in 2023 and Paxlovid another $8 billion in 2023. That would be a 64% and 58% reduction compared with the 2022 figures.

The company attributes part of the sales decline to ample U.S. government supply of the products.

The government plans to transition COVID-19 vaccines and other therapies to the private ma…

Yale opens center to study cannabis and cannabinoids

[CBD molecule courtesy of PubChem]

Yale School of Medicine has established a research center, the Yale Center for the Science of Cannabis and Cannabinoids, to investigate how cannabis and cannabinoids affect neurodevelopment and mental health. Led by Dr. Deepak Cyril D’Souza, an expert in cannabinoid pharmacology, the center will use a multidisciplinary approach to study the acute and chronic effects of these substances.

Yale psychiatry chair Dr. John H. Krystal, and the university’s dean of medicine, Dr. Nancy J. Brown, announced the establishment of the new cannabinoids center on January 30, 2023.

The two said the center’s opening was timely given the rapid commercialization of cannabis in the U.S. In addition to internal funding, the new center will intend to secure a P50-type center grant for further research.

Booming cannabinoids interest but relatively limited research

Int…

CureVac reports positive outcomes for COVID-19 and flu mRNA vaccines in seniors

The biopharma CureVac (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive extended preliminary data from two Phase 1 mRNA vaccine trials, one involving COVID-19 and another seasonal flu.

The company says the positive data support the next stage of clinical testing for modified mRNA COVID-19 and flu vaccines in 2023.

CureVac, which struggled to gain traction for its first-generation mRNA COVID-19 vaccine, is using a second-generation mRNA backbone for its latest mRNA COVID-19 and flu vaccines.

In early January, CurVac announced positive preliminary data from the Phase 1 clinical programs in COVID-19 and seasonal flu.

In a CureVac call with analysts, Umer Raffat, senior managing director at Evercore, stated that the data released then were “half-baked,” adding that a lot of more data from the ongoing Phase 1 study was forthcoming.

“This is a Phase 1 with small numbers, but I think the data clearly show the i…