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Monday, October 10, 2022
Janssen Touts Encouraging Data From Two Ulcerative Colitis Treatments
- Janssen Pharmaceutical, a unit of Johnson & Johnson , announced data from an ongoing analysis of a Phase 2a trial of guselkumab and golimumab combo therapy for ulcerative colitis.
- The results showed that 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission rate at week 38 of 47.9%, a higher rate than induction and maintenance treatment with either guselkumab alone (31%) or golimumab alone (20.8%).
- Endoscopic improvements and the composite histologic-endoscopic endpoints & remission were higher in patients who received combination therapy followed by treatment with guselkumab than those who received guselkumab or golimumab alone.
- Patients receiving combination therapy followed by maintenance treatment with guselkumab and patients receiving only guselkumab monotherapy achieved the same rate of symptomatic remission of 69%, which was greater than the golimumab monotherapy group of 59.7%.
- Janssen also announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating the efficacy and safety of STELARA (ustekinumab) through four years of treatment for moderately to severely active ulcerative colitis (UC).
- Among all patients who had achieved clinical response with STELARA during induction, 64.9% were in symptomatic remission after 44 weeks of maintenance.
- At week 200 (four years), this proportion of patients was 55.2%; most were not receiving corticosteroids.
Developing monoclonal antibodies to fight chronic pain
A group of researchers based out of University of California Davis recently received a $1.5 million grant from the National Institutes of Health to develop monoclonal antibodies for use against chronic pain.
“It’s a challenge to be able to develop safe and effective drugs to treat pain,” says Vladimir Yarov-Yarovoy at University of California Davis School of Medicine. Opioid painkillers like oxycodone (OxyContin) can be addictive for some people, and others like fentanyl have played a large part in the opioid misuse and overdose crisis.
Monoclonal antibodies are already being used as treatments for some types of cancer. A few types of monoclonal antibodies were also given emergency use authorization from the U.S. Food and Drug Administration (FDA) to fight COVID-19.
In a similar vein as chronic pain, the FDA has already approved a monoclonal antibody treatment for migraine headaches. The novel therapy targets a specific signaling molecule called CGRP. The antibodies block CGRP, which researchers think plays a role in the nerves linked to the blood vessels in the brain, according to Nature.
Although it only works for a subset of patients, this is a step forward for migraine treatment because of how effective it is for the people it does work for. In addition, patients on the migraine treatment have had minimal side effects, and that could be true too for other monoclonal antibody treatments.
Complications from a monoclonal antibody treatment will depend on if the antibodies are specific enough, meaning that they bind well to their targets and not much else.
For Yarov-Yarovoy and collaborators, this is where the high resolution imaging and computational tools come in. Based on past research, the team are focused on three ion channels in the membranes of nerve cells. Ion channels allow molecules to pass into and out of the cell based on if they are activated or deactivated. This kind of movement of molecules is the basis for many types of signaling in the body, including pain.
The receptors where an antibody can bind to on the membrane channels are highly complex structures. Yarov-Yarovoy says that the imaging and computational techniques have become much more powerful in recent years and hopes that will help the team develop these new antibodies.
If they do develop the right antibodies, this treatment could be given as an intravenous injection. The antibodies could circulate in the bloodstream for up to a month before getting broken down, meaning that patients could potentially get this shot and feel the benefits for weeks.
The team think that if this research works out that a monoclonal antibody treatment for chronic pain could be a good alternative to opioids because it would not be addictive and could have few side effects.
The Centers for Disease Control and Prevention estimates that 20 percent of adults have chronic pain and 8 percent of adults in the U.S. experience high impact chronic pain. In the ongoing opioid epidemic, tens of thousands of people die from overdoses each year. The White House recently announced $1.5 billion initiative to combat addiction and opioid misuse. If a monoclonal antibody treatment for chronic pain were to receive FDA approval, that could provide another option for doctors to prescribe and could prevent people from becoming addicted to or dependent on opioids.
This would all depend on years of extensive research and clinical trials before it could get into regular use, and it could end up being a very expensive treatment. “We’ll see how broad the actual usefulness of these antibodies in the future,” says Yarov-Yarovoy. “We don’t think there is one magic, basic treatment for all the patients with chronic pain, but what we hope is that it will help some patients with chronic pain.”
Poland checks condition of bomb shelters
Polish fire services are checking the condition of the country's bomb shelters and compiling an inventory, a deputy minister said on Monday, following Russia's invasion of Ukraine.
While NATO member Poland has reassured citizens that its place in the alliance guarantees their safety from Russian attack, events in neighbouring Ukraine have brought into focus the need to be prepared for the possibility of a missile strike.
"We have 62,000 such facilities across the country," Deputy Interior Minister Maciej Wasik told private broadcaster Polsat News.
"Firefighters are checking their condition, whether they are equipped, and whether they are fit for use. If not, we will take steps to adapt them."
Wasik said Poland was not under threat, but was preparing for the worst-case scenario.
"These are routine activities," he said. "This action was planned some time ago."
The process of checking the shelters will last two months.
https://www.marketscreener.com/news/latest/Poland-checks-condition-of-bomb-shelters--41972930/
Pfizer exec denies CEO negotiated EU COVID vaccine contract via text message
A Pfizer executive with a lead role in negotiating a COVID-19 vaccine bulk supply agreement with the European Commission "categorically" ruled out that the U.S. drugmaker's chief executive agreed the contract via mobile phone text messages.
"As to whether a contract negotiation such as this contract which you referred to, 1.8 billion doses, was negotiated through an SMS, I can categorically tell you that would not be the case," Janine Small, president of international developed markets at Pfizer, told the European Parliament's special committee on COVID-19 on Monday.
She added that such talks involve far too many people on both sides and take far too long to be conducted via mobile phone texts.
"I know that because I was involved in all the negotiations and discussions from the very start in 2020," Small said.
In an interview with the New York Times in April 2021, European Commission President Ursula von der Leyen revealed she had exchanged texts with Pfizer Chief Executive Albert Bourla for a month while the contract was under negotiation, prompting calls to publish the exchange.
The Commission said in June this year that it no longer had the texts, which later drew criticism from the European Union's ombudswoman.
The contract signed last year was the biggest ever sealed for COVID-19 vaccines, with the EU committing to buy 900 million Pfizer-BioNTech shots, with an option to buy another 900 million
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