Recruitment in NATiV3 clinical trial continues in both cohorts with over 80% of the targeted number of patients enrolled in the main cohort and 100% in the exploratory cohort of NATiV3.
Analysis of the baseline characteristics of all patients randomized in the main cohort of NATiV3 show a patient profile similar to patients randomized in the NATIVE Phase IIb clinical trial.
A blinded analysis of all randomized patients suggests weight gain plateaus and stabilizes between week 24 and 36.
First visit of the last patient of NATiV3 is anticipated to occur during the second half of 2024, and topline results are expected at the beginning of the second half of 2026.
Patent portfolio strengthened with new patent secured protecting the compound until 2043.
The Company is currently working on multiple fronts to secure financing to fund the continuity of its activities.
The White House has announced that President Joe Biden will'likely' meet with Prime Minister Benjamin Netanyahulater this month, when he'll be in Washington to address a joint session of Congress on July 24.
His invitation to address Congress by Republicans has already proven divisive, given a number of Democrats have declared they intend to boycott it. Likely dozens will not be in attendance, similar to what happened when the Israeli premier addressed Congress nearly a decade ago.
On Wednesday a White House official told The Times of Israel that "The president has known Prime Minister Netanyahu for three decades. They will likely see each other when the prime minister is here over the course of that week, but we have nothing to announce at this time."
But tensions have been soaring, given just last month the White House canceled a meeting with an Israeli national security delegation after Netanyahu issued a video chastising the US for withholding some weapons shipments. The White House was left furious.
At the time, Biden press secretary Karine Jean-Pierre called into question the Israeli leader's narrative. "We genuinely do not know what he’s talking about. We just don’t," she told reporters.
She had noted that "there was one particular shipment of munitions that was paused, and you’ve heard us talk about that many times." Jean-Pierre then emphasized, "There are no other pauses — none — no other pauses or holds in place."
Biden has over the last months on various occasions gone negative against the 'far right' Netanyahu government, despite Israel having long been a very close US ally, over human rights abuses and mass killings in Gaza.
The US administration has on the one hand continued to approve of major weapons and aid packages to Israel, but on the other has highlighted the soaring civilian death toll due to the IDF offensive. Progressive Democrats have made their anger known, with many vowing to not vote for Biden in November.
Newsweek has recently highlighted Congressional Democrat discontent with Biden's Gaza policy in the following:
The AP reported that interviews with more than a dozen Democrats revealed the discontent over Netanyahu's upcoming speech, and how some feel it is a Republican ploy to divide Democrats.
Some Democrats have said they will attend Netanyahu's speech to show support for Israel, but others are clear that they won't be attending.
Rep. Lloyd Doggett, a deputy whip for the Congressional Progressive Caucus, has stated that Netanyahu "needs to be staying in Israel and working for the peace that he has been unwilling to support in the past."
The "indiscriminate bombing that he has encouraged... has led to loss of lives that should never have happened. He has not prioritized the hostages; he ought to be doing that instead of coming here," he told The Hill days ago.
While the headlines are all about the Labour landslide in the UK general election this morning, Wes Streeting, who has been shadow health secretary in opposition and may well have the equivalent role in government, came perilously close to losing his seat.
The Ilford North MP won with just over 500 more votes than British-Palestinian independent candidate Leanne Mohamad, whose campaign focused on the Gaza conflict. He held on though, to take his place in Labour’s massive majority, with 411 seats at last count versus 120 for the Conservatives.
Wes Streeting
Streeting acknowledged in an interview with Channel 4 news last night that, while it will take more than one term to get the NHS back on its feet, Labour will have to show progress in the first five years.
“The NHS is going through what is objectively the worst crisis in its history,” he said, pointing to patients waiting for too long in A&E, dying while on record waiting lists, and struggling to access GP services.
“Unless it reforms and modernises, it is not going to survive the 21st Century. It’s not going to be there for us when we need it,” he added.
Streeting said that Labour has set some “tough, ambitious, but achievable targets” for the health service, including getting waiting lists down within one term, and wants to deliver “the best healthcare service in the world” within a decade.
Its plan includes a pledge to reduce lives lost to the diseases that are the biggest killers, closing the gap in healthy life expectancy between those from the wealthiest and poorest backgrounds, and tackling the racial disparities within the NHS.
He also emphasised, however, that the NHS’ challenges are taking place against a revolution in life sciences and medtech, in which the UK is still playing a prominent role.
The Labour government will make technological advances like artificial intelligence and precision medicine a key part of its plans to reform the NHS and foster close partnerships with industry, said Streeting.
Industry on board
The Association of the British Pharmaceutical Industry (ABPI) has already indicated it was happy with many elements of Labour’s manifesto, particularly the singling out of the UK’s life sciences sector as a critical partner for the new government’s plans to deliver economic growth.
It said after the document was published that it was encouraged by Labour’s ambition for a ‘plan for procurement’ – aimed at giving a clearer route for products to be introduced into the NHS – along with reformed incentive structures to drive innovation and faster regulatory approval for new technology and medicines.
“A strong industry-government partnership will be vital to ensure that we continue to discover breakthrough medical innovation in the UK and ensure NHS patients are among the first people in the world to benefit from the latest medicines and vaccines,” said Richard Torbett, the ABPI’s chief executive.
“The new government now needs to hit the ground running and rapidly set out a clear, detailed plan for what the government will do in the coming weeks and years to address persistent inequalities in access to medicines and vaccines as well as unlock our sector’s true growth potential,” he added.
Steve Bates, chief executive of the BioIndustry Association, said: “The incoming Labour government has been elected with a clear mandate to prioritise economic growth and its manifesto identified the life sciences sector as a great British industry primed to deliver it. We are looking forward to working with the new team on this mission. The Labour Party’s life sciences sector plan published in February shows the ground work already laid on which a new life sciences strategy can be built. Addressing the chronic underinvestment by the UK pension industry in start-ups and scale-ups, and fine-tuning the tax system to support innovation-led growth, will be the first orders of business."
He added: “The general election has also delivered a fantastic cohort of scientifically-engaged MPs, with biomedical researchers and biotech leaders taking their place on the green benches in the Palace of Westminster. Their knowledge and understanding of innovation will be critical as the UK finds its way in a new global era where science and innovation will determine country’s economic and social progress."
Pieris Pharmaceuticals’ long-standing immuno-oncology alliance with Servier is being dissolved after a clinical trial of the lead drug in the alliance revealed a safety concern.
In a Securities & Exchange Commission (SEC) filing, Pieris said that Servier will exit the agreement between the two companies – first agreed in 2017 and focusing on the development of several Anticalin-based therapeutics for cancer – before the end of the year.
The prompt for Servier's exit was a decision to stop dosing S095012 (formerly PRS-344), a 4-1BB/PD-L1 bispecific protein, in a phase 1 trial. Pieris said it intends to review the safety data from the S095012 study to understand the implications of the data, but does not intend to pursue any further development of the drug.
Servier paid Pieris $31 million to start up the alliance, which spanned five bispecific drugs and could have been worth up to $1.8 billion. The lead drug at the time of signing was PRS-332, a CD223/PD-L1 bispecific protein that also seems to have fallen by the wayside.
This time last year, Pieris also lost a partnership with AstraZeneca on respiratory drug candidate elarekibep, one of up to five Anticalin therapies covered by a deal also signed in 2017, with an upfront payment of $57.5 million and top-line value of $2.1 billion.
The decision to drop elarekibep, an inhaled IL-14 inhibitor being developed for severe asthma, was taken because of a safety issue that was observed in preclinical studies involving non-human primates. Pieris slashed its headcount by 70% in the wake of AZ’s decision and started a strategic review of the business.
Pieris’ Anticalin technology is designed to make protein drugs that have smaller molecule sizes, so are easier to deliver, and can bind to more than one target in a single molecule.
In its SEC update, Pieris noted that it had embarked on another strategic review in March that will be geared towards getting milestone payments from its other partnerships, currently with Boston Pharmaceuticals and Pfizer, which also involve 4-1BB bispecific proteins.
Pfizer is developing SGN-BB228, a CD228/4-1BB candidate it inherited as part of its takeover of Seagen, while Boston is working on BOS-342, a GPC3/4-1BB drug. Both are in phase 1 testing, and Pieris says it is in line for up to $330 million in research, development, and commercial milestones across the two programmes.
The company reported it held cash of $19 million at the end of the first quarter.
Danish drugmaker Novo Nordisk has been reprimanded by UK regulators for failing to disclose fees and expenses paid to individuals and organisations in Britain amounting to about 7.8 million pounds ($9.97 million) between 2020 and 2022.
The UK industry body Prescription Medicines Code of Practice Authority (PMCPA) said on Friday that the reprimand followed a voluntary submission by Novo about the payments, which related to more than 150 different bodies and included fees and expenses to health professionals and sponsorship and other payments to healthcare organisations.
Novo, whose valuation has soared following the success of its diabetes drug Ozempic and weight loss treatment Wegovy, said on Friday that it had made the voluntary admission in 2023 after it found historical payments that had not been disclosed.
"These payments are for legitimate activities but had been incorrectly categorised in finance systems as a result of human error," the company said in a statement.
"We accept the PMCPA's decision to rule the relevant breaches of the two Codes of Practice which applied during the timeframe for this case and agreed that this was the appropriate ruling as part of our voluntary admission."
In March last year Novo was suspended from the Association of the British Pharmaceutical Industry (ABPI), a UK lobby group, for two years over breaches of the group's code of practice.
ABPI linked to a website of a self-regulatory body run by the association that pointed to a complaint, alleging that Novo had sponsored courses on weight management on LinkedIn for health professionals, without making clear that it was doing so.
The PMCPA also said on Friday that Swiss pharmaceuticals company Novartis and US rival Pfizer had breached the ABPI's code of practice in more minor ways that brought discredit upon, and reduced confidence in, the pharma industry.
President Volodymyr Zelenskiy said on Friday he wanted to double Ukraine's air defence capacity over the summer after receiving the country's third German-supplied Patriot system in response to pleas for equipment to guard against Russian air strikes.
Moscow renewed its aerial assaults on Ukraine's national power grid in the spring, causing sweeping blackouts. Zelenskiy has said his country needs at least seven additional Patriot systems to protect itself.
"I set a task for our team to double our defence capabilities this summer, primarily Patriot and others," Zelenskiy told regional leaders, referring also to U.S. Hawk and German Iris systems.
"And now we are starting to see results."
In his comments, posted on his Telegram channel, Zelenskiy said Ukraine had also received on Friday "additional support," from the United States, but gave no details.
Earlier, in his nightly video address, the president expressed gratitude to Germany for providing the third Patriot system.
German Ambassador to Ukraine Martin Jaeger added on X that the newly supplied system will further protect civilians and critical infrastructure.
"The Ukrainian crew has successfully completed appropriate training in Germany," he said.
Kyiv has indicated it hopes for progress on air defence supplies at a NATO summit in Washington next week. A senior U.S. State Department official has said Kyiv is expected to get "good news" at the summit.
Russia launched its full-scale invasion of Ukraine in February 2022 and regularly uses its arsenal of missiles and drones to conduct long-range strikes.
Born in 1965 with spina bifida and a myelomeningocele, I am no stranger to pain. My fate would have been sealed had it not been for my stubborn Irish father, a Marine who referred to himself as my Old Man. The preferred method of treatment for a case like mine was euthanasia. Neither the Old Man nor my Catholic mother would hear of it, and at nine days old I had the first of 59 surgeries.1 Although they were warned that I would be a liability, live a life of pain and disability, and barely function cognitively, the 20-something parents decided that my fate would be up to God, period.
I don't need to give any more history for folks to know that I was a "hospital institutionalized" child. Corrective orthopedic surgeries allowed me to ambulate, a urostomy at age 6 freed me from diapers, and the stubborn Old Man gave me balls of steel because he never, ever, allowed me to sit in self-pity. I hated him for it. He began every morning with, “Let go of your cocks and grab your socks…" He expected me to do chores and behave responsibly like every other kid in the neighborhood. I secretly resented him, wishing that the "spina bifida police" would come, see me pushing the mower in the yard, and punish him for spina bifida child abuse. They'd tie a ball and chain around his ankle, and he'd have to drag it while cutting the lawn. I’d watch and tell him to get busy with a bullhorn. And I would be pleased.
So, it was no surprise that I got addicted to opioids.
Opiate use for my chronic non-cancer pain was chasing a ghost. I had pain, I would take meds, I would feel good and be able to function, and then have increased pain and need more meds. The cycle took 18 years to break. For prescribers reading this, PLEASE review the history of opiate liberation and how a bullshit term like "pseudo-addiction" came to be scientific vernacular and how Porter and Jick became one of the most cited articles (really just five sentences) for denying that addiction could occur with liberal opioid treatment for chronic non-cancer pain. An opinion letter became “scientific evidence.” Suffice to say we are paying that price now, as pharma sponsored "experts" touted the holy trinity of addictive drugs (carisoprodol, amphetamines, and opioids) to attempt to treat chronic non-cancer pain.
When emergency bone surgery was necessary three months into my sobriety, I was frightened because the hospital was essentially my crack house. I was more afraid of relapse than pain. And this was a painful surgery. Here is where experience, accountability, and compliance come into play.
1. When faced with that surgery early into my own recovery, I designed a plan based on my recovery, which included support from other sober people, strong connection to my addictions doc, Dr. Greg Collins, and my sponsor. We decided to limit opioids and have strong accountability for pain. Our primary rule was to use post op opioids sparingly; long-acting if possible, never a former drug of choice, and no PCA (nothing like feeling you have control over IV opioids as an opioid addict…bad idea…). A corollary was to avoid the doses for "breakthrough pain" as much as possible; scheduled short acting meds are preferred as that reduces cues associated with active addiction. This stops "clock watching" and reduces the cognitive dissonance for a patient who already possesses manipulation skills used to feed addiction.2
The surgery went well and what I learned became a template for the last 25 years anytime I have needed surgery and opioids.
2. My fear before that surgery was that ANY opioid would trigger me (news flash – they ALL do to a degree, let nobody tell you differently… it’s like dancing with an old lover when you know that dalliance is sure to end badly). I initially told my doctors that I wanted NO opioids. I will never forget Doc Collins saying to me, “Just be a fuckin’ patient; we will help you no matter what.” We do not recover in a vacuum. Accountability was key, and I did not need anything stronger than ibuprofen during the 6 weeks of treatment. My recovering friends brought meetings to me, I spoke with my sponsor every day, and – yes – prayer was huge for keeping me focused on recovery. For me, the best way to avoid iatrogenic relapse is to use the guidelines of accountability, honesty with self, and to avoid any intravenous and short acting opioids. ANYTHING mood altering poses risk.
3. Another important issue, that I saw repeatedly during my practice as a chronic pain and addiction clinician, first presented itself when I was consulting on a patient who had been on a long stable dose of methadone. She had been in a horrific T-bone crash and had several large bone breaks. The treatment team assumed that “the large dose of methadone would be enough” for post op pain management – mistake number one. They then reduced the dose for fear of overdose – mistake number two. The patient was in withdrawal by the time I was called. We managed her by reinstating her baseline dose and titrated additional opioids and adjuvants from there. She ended up doing very well and was able to remain on methadone after healing. I was stunned to learn how little education was devoted to addiction for medical students. I realized that I would need to be heavily involved in my own care should acute pain be an issue for me.
In summary, here is the bottom line that comes from many years of practicing recovery principals in all my affairs. It is what I tell every recovering addict, "If you have to negotiate whether you need it or not for your current acute pain, then you don't need it." I try to make this general, speaking from what worked for me and what I’ve seen work in my professional experience.
Jim Ryser has been known as “Jimmy Ryser” -- a musical artist with a hit song in 1990 and one-time guitarist for John Mellencamp – and also as Jim Ryser after sobriety forced him “to grow up to become a responsible chronic pain and addiction clinician.” Health has forced him into early retirement during which he lives his best life within the boundaries of chronic health problems.
I was a skilled manipulator. At the time he first achieved sobriety, I had 13 different prescribers writing for me. It was a full-time job, one that I never wanted to return to.
