LILLE, France & PARIS--(BUSINESS WIRE)--Jan 8, 2026--
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The U.S. Food and Drug Administration (FDA) approval marks another strategic step in 4MB’s global clinical deployment across Europe, Canada, and now the U.S., reinforcing the company’s role as a front-runner in the race to deliver the first disease-modifying osteoarthritis drug (DMOAD) to patients worldwide. Preclinical studies have shown that 4P004 can modulate multiple biological markers across the whole joint, supporting its potential as a first-in-class DMOAD capable of slowing structural impairment and improving joint function.
“FDA’s clearance of our IND represents a major validation of our program and enables the full execution of our clinical strategy across Europe, Canada, and the United States,” said Luc Boblet, Chief Executive Officer of 4Moving Biotech. “This milestone strengthens our position as one of the most advanced DMOAD developers globally and brings us closer to demonstrating the transformative potential of 4P004 for the millions of patients worldwide who currently have no disease-modifying options.”
The INFLAM MOTION trial is a 3-month, multicenter, randomized, double-blind, placebo-controlled Phase 2a study designed to enroll 129 patients suffering from knee osteoarthritis with synovitis. The trial includes:
This unique combination of clinical, imaging, and biomarker elements forms the foundation for future interactions with regulatory agencies on accelerated or conditional approval pathways, thereby strategically positioning 4P004 within the highest-priority segment of OA drug development.
“4P004, a GLP-1 receptor agonist administered intra-articularly, allows specific targeting of the diseased joint and joint tissues, aiming to relieve pain while also addressing the underlying disease process, thus offering an exciting novel approach for patients living with painful knee osteoarthritis. As the U.S. Coordinating Investigator, I am pleased to support the INFLAM MOTION study and look forward to evaluating this promising therapeutic approach for patients with knee osteoarthritis.”Thomas J. Schnitzer, MD, PhD,Professor of Medicine,Northwestern University
Professor Francis Berenbaum, MD, PhD, Chief Medical Officer of 4MovingBiotech, concluded: “The regulatory progress across three major regions underscores the scientific robustness of 4P004. INFLAM MOTION is designed to deliver clinically meaningful pain improvement while generating high-resolution structural and biological data to guide the next stage of development. We believe 4P004 has the potential to redefine how osteoarthritis is treated.”
4Moving Biotech will initiate patient enrollment in the United States in Q1 2026, following site activation and investigator onboarding.
About 4Moving Biotech
Founded in 2020 as a spin-off of 4P-Pharma, 4Moving Biotech is a clinical-stage biotechnology company developing disease-modifying drugs for osteoarthritis, one of the world’s most burdensome chronic diseases, affecting more than 600 million people and lacking approved therapies that alter disease course. Headquartered on the Pasteur Institute campus in Lille, 4MB aims to deliver safe, sustainable therapeutic solutions for patients with high unmet medical needs.
Website: www.4movingbiotech.com
LinkedIn: https://fr.linkedin.com/company/4moving-biotech
X : https://x.com/4Moving_Biotech
4Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for 4P004, enabling the expansion of the Phase 2a INFLAM MOTION clinical trial into the United States (US).
ALBANY, N.Y. (AP) — A judge disqualified a Trump administration federal prosecutor from overseeing investigations into New York Attorney General Letitia James, ruling Thursday that he is not lawfully serving as an acting U.S. attorney.
U.S. District Judge Lorna G. Schofield blocked subpoenas requested by John Sarcone, the acting U.S. attorney for the Northern District of New York. The judge said the Department of Justice did not follow statutory procedure after judges declined to extend Sarcone’s tenure last year.
Schofield joined several other federal judges across the country who have ruled that actions taken by top federal prosecutors were invalid because of unusual methods that the Trump administration used to get them the jobs. People were given the power of a U.S. attorney outside of the normal U.S. Senate confirmation process or were allowed to serve until federal judges in their district could decide whether they could stay.
“When the Executive branch of government skirts restraints put in place by Congress and then uses that power to subject political adversaries to criminal investigations, it acts without lawful authority. Subpoenas issued under that authority are invalid. The subpoenas are quashed, and Mr. Sarcone is disqualified from further participation in the underlying investigations,” the judge said in her decision.
Schofield said Sarcone is not lawfully serving as acting U.S. attorney and that any “of his past or future acts taken in that capacity are void or voidable as they would rest on authority Mr. Sarcone does not lawfully have.”
James, a Democrat, had challenged Sarcone’s authority after he issued subpoenas seeking information about lawsuits she filed against Republican President Donald Trump, claiming he had committed fraud in his business dealings, and separately against the National Rifle Association and some of its former leaders.
Justice Department lawyers argued Sarcone was appointed properly and that the subpoenas were valid. James claims the inquiry into her lawsuits is part of a campaign of baseless investigations and prosecutions of Trump’s perceived enemies.
James’ office issued a statement calling Thursday's ruling “an important win for the rule of law.”
“We will continue to defend our office’s successful litigation from this administration’s political attacks,” the statement said.
Emails seeking comment were sent to the U.S. Attorney’s Office and the Department of Justice.
Last month, a panel of judges from the 3rd U.S. Circuit Court of Appeals sitting in Philadelphia sided with a lower-court judge’s ruling disqualifying Alina Habba from serving as New Jersey’s top federal prosecutor.
In November, a federal judge dismissed criminal cases against former FBI Director James Comey and James after concluding that the hastily installed prosecutor who filed the charges, Lindsey Halligan, was unlawfully appointed to the position of interim U.S. attorney for the Eastern District of Virginia.
A similar dynamic has played out in Nevada, where a federal judge disqualified the Trump administration’s pick to be U.S. attorney there. And a federal judge in Los Angeles disqualified the acting U.S. attorney in Southern California from several cases after concluding he had stayed in the job longer than allowed.
In New York, U.S. Attorney General Pam Bondi appointed Sarcone to serve as the interim U.S. attorney in March. When his 120-day term elapsed, judges in the district declined to keep him in the post.
Bondi then appointed Sarcone as a special attorney and designated him first assistant U.S. attorney for the district, moves that federal officials say allow him to serve as an acting U.S. attorney.
The judge, who sits in New York City, took issue with the Justice Department's actions.
“(O)n the same day that the judges declined to extend Mr. Sarcone’s appointment, the Department took coordinated steps — through personnel moves and shifting titles — to install Mr. Sarcone as Acting U.S. Attorney. Federal law does not permit such a workaround,” she wrote.
Sarcone was part of Trump’s legal team during the 2016 presidential campaign and worked for the U.S. General Services Administration as the regional administrator for the Northeast and Caribbean during Trump’s first term.
Schofield said the federal government could reissue the subpoenas at the direction of a lawfully authorized attorney.
Joshua Naftalis, a Manhattan federal prosecutor for 11 years before entering private practice in 2023, said Schofield was agreeing with the other judges who have disputed the authority of designated top prosecutors.
“It’s always a big deal when judges say that the U.S. attorney doesn’t have the authority,” he said.
He said subpoenas aren’t typically issued by a single prosecutor so the ruling might not directly affect other investigations brought through the prosecutor’s office.
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Associated Press writer Larry Neumeister contributed from New York.
FILE - John Sarcone, acting U.S. Attorney for Northern New York, leaves Manhattan federal court, Thursday, Dec. 4, 2025, in New York. (AP Photo/Michael Sisak, File)
New York Attorney General Letitia James arrives at City Hall for the public inauguration swearing-in ceremony of Mayor Zohran Mamdani, Thursday, Jan. 1, 2026, in New York. (AP Photo/Heather Khalifa)
