4P-Pharma

4Moving Biotech, a clinical-stage biotechnology company headquartered at the Pasteur Institute in Lille, France, announced receipt of US FDA Fast Track Designation for 4P004, a glucagon-like peptide-1 (GLP-1) analog engineered for intra-articular administration. The award focused on the molecule’s potential use as a third-line treatment of knee osteoarthritis in patients with synovitis. Fast Track Designation enables more frequent FDA interactions during development, including rolling review of data, and applies here to a program that has no prior expedited designation on record. The designation is specifically scoped to a treatment-refractory knee osteoarthritis subpopulation defined by the presence of synovitis, a narrower target than the broader disease category. 4P004 is formulated for direct injection into the knee joint rather than systemic administration. The company describes it as leveraging GLP-1’s analgesic, anti-inflammatory, anti-catabolic, and anabolic properties across joint tissues, with the intent of modifying disease progression rather than providing symptomatic relief alone. 4Moving Biotech was spun out of 4P-Pharma in mid-2020 and does not carry a stock exchange listing. The Phase I LASARE trial, results from which were disclosed in June 2024, enrolled 34 patients with knee osteoarthritis across three Belgian sites in a randomized, double-blind, placebo-controlled design. Single intra-articular injections of 4P004 were tested at doses from 0.3 mg to 3.0 mg. The trial met its primary safety objective, with expected adverse events in the 4P004 groups comparable to placebo. Pharmacokinetic data showed systemic liraglutide exposure below levels reported for subcutaneous administration of the approved formulation Victoza, which the company cited as supporting a 505(b)(2) regulatory pathway in the US. A pharmacologically active dose was identified from the ascending-dose cohorts. No specific pain endpoint scores, p-values, or quantitative PK parameters were disclosed in the public announcement; those figures were not available in any parallel public source at the time of writing. The ongoing Phase IIa INFLAM MOTION trial (CTIS2024-518916-38-00) is a multicenter, randomized, double-blind, placebo-controlled proof-of-concept study enrolling patients with knee synovitis and osteoarthritis across sites in the EU and North America. Topline results are expected in early 2027. The company states that US enrollment was enabled following an Investigational New Drug (IND) clearance in January 2025. No disease-modifying osteoarthritis drug (DMOAD) has received regulatory approval from the US FDA, EMA, or any other major agency. Approved pharmacological options for knee osteoarthritis — including non-steroidal anti-inflammatory drugs, duloxetine, and intra-articular corticosteroids or hyaluronic acid — address symptoms without altering structural disease progression. The subpopulation targeted by 4P004, patients with active synovitis who have failed multiple prior therapies, has no approved disease-modifying option. 4P004’s mechanistic distinction from prior DMOAD candidates lies in its use of the GLP-1 pathway at the joint level. Unlike sprifermin, which targets chondrocyte proliferation via FGF18, or lorecivivint, which inhibits CLK2 and DYRK1A to modulate Wnt signaling, 4P004 is positioned to act on inflammatory, catabolic, and anabolic pathways simultaneously through GLP-1 receptor engagement in joint tissue. The intra-articular route is shared with sprifermin and lorecivivint, and is intended to limit systemic exposure — a design rationale that the LASARE PK data were cited to support. The GLP-1 receptor biology underlying 4P004 is distinct from the systemic metabolic applications of GLP-1 agonists such as semaglutide or liraglutide. Whether GLP-1 receptor expression in synovial tissue and chondrocytes is sufficient to drive the anti-catabolic and anabolic effects the company describes has not been established in peer-reviewed clinical data from the 4P004 program to date. The INFLAM MOTION trial is designed to generate the translational evidence needed to address that question. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

FDA Fast Track Designation granted to 4P004 for the treatment of knee osteoarthritis, recognizing the disease as a serious condition with significant unmet medical need Designation supports enhanced regulatory interactions and alignment on efficient post-Phase 2a development strategies, including potential accelerated pathways LILLE, France & PARIS--(BUSINESS WIRE)-- 4Moving Biotech (4MB), a clinical-stage biotechnology company developing next-generation Disease-Modifying Osteoarthritis Drugs (DMOADs), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to 4P004 for the treatment of knee osteoarthritis in patients with synovitis who have not benefited from at least two prior pharmacological therapies. This designation highlights both the serious burden of knee osteoarthritis and the persistent lack of disease-modifying treatment options. It also reflects the strong scientific rationale supporting the 4P004 development program, including its targeted intra-articular approach and the role of synovitis as a key marker of disease progression. 4P004 is a GLP-1 analog specifically engineered for intra-articular administration in the knee. It is designed to leverage the pleiotropic properties of GLP-1, including analgesic, anti-inflammatory, anti-catabolic, and anabolic effects across multiple joint tissues involved in pain, functional impairment, and structural disease progression. This differentiated mechanism of action supports the positioning of 4P004 as a potential first-in-class DMOAD, aiming to move beyond symptomatic relief and address the underlying pathological processes of osteoarthritis. “Fast Track Designation represents a meaningful regulatory milestone for the 4P004 program,” said Luc Boblet , CEO of 4Moving Biotech . “It reflects the significant unmet medical need in knee osteoarthritis and provides a structured framework for enhanced dialogue with the FDA as we prepare the next stages of development. Importantly, it will allow us to align on regular basis with the Agency on the most appropriate development pathway following Phase 2a, including the exploration of innovative approaches to accelerate patient access.” For 4Moving Biotech, this designation reinforces the company’s global development strategy by enabling early, continuous, and structured interaction with the FDA. It is expected to facilitate alignment on key development decisions, including study design, endpoint selection, and the overall regulatory pathway, with the objective of optimizing timelines and maximizing the probability of success. The ongoing INFLAM MOTION Phase 2a trial is designed to generate key clinical and translational data to inform subsequent regulatory interactions and support future development decisions, including potential accelerated development strategies. Together, these elements position 4P004 as a high-priority therapeutic candidate with the potential to meaningfully advance treatment options for patients living with knee osteoarthritis. “Current pharmacological treatments for knee osteoarthritis provide limited and often transient relief,” said Prof. Francis Berenbaum , Chief Medical Officer of 4Moving Biotech . “4P004 has been designed to address both symptoms and underlying disease mechanisms in patients with limited therapeutic options. The Fast Track Designation strengthens our ability to generate the evidence needed to support future regulatory decision-making and ultimately patient drug access.” In addition, Fast Track Designation allows the company to explore, within a structured regulatory framework, whether early access options such as expanded access programs may become appropriate for patients with limited treatment alternatives once robust clinical data are available. The INFLAM MOTION Phase 2a trial is advancing both in EU and North America (US & Canada) with topline results expected in early 2027. About 4MB Incorporated in mid-2020 as a spin-off of 4P-Pharma, 4MB is a clinical stage biotechnology company dedicated to the development of the Disease-Modifying Osteoarthritis Drug (DMOAD). Its mission is to provide a sustainable therapeutic solution to the significant unmet medical need of osteoarthritis. The company is headquartered at the Pasteur Institute in Lille, France. Website: LinkedIn: The only version of the 4Moving Biotech press release that is legally binding is the one in its original language. Translations must always be compared to the source text, which will establish precedence. The press release text resulting from a translation should not be considered official in any way. Contacts Contacts Press Emmanuel Dadjé Communication Manager Emmanuel.dadje@4P-Pharma.com +33 6 30 06 12 13

- Funding secured, extending the financial runway to reach a proof-of-concept inflection point - Company’s attractiveness reinforced through the onboarding of new investors LILLE, France & PARIS--(BUSINESS WIRE)--4Moving Biotech (4MB), a clinical-stage biotechnology company and a spin-off of 4P-Pharma, developing a first-in-class disease-modifying osteoarthritis drug (DMOAD) for knee osteoarthritis, today announced the closing of a €12 million financing, completed through a structured and coordinated funding process. This financing was secured from a pool of private investors and family offices, who chose to reinforce their commitment by investing directly at the subsidiary level in 4MB. The round includes a combination of equity and loans, reflecting a flexible capital structure aligned with long-term value creation. This closing forms a natural continuum following the €7.6 million France 2030 i-Démo grant announced last year, and the very recent transatlantic extension of the INFLAM-MOTION Phase 2a clinical study to the US, reinforcing 4MB’s runway to execute its lead DMOAD program addressing a major unmet medical need in knee osteoarthritis. “With this closing in place, we are well equipped to reach the next value creation milestone by delivering robust Phase 2a data, reaching a proof-of-concept inflection point, and creating strategic optionality for subsequent stages of development to address the needs of the 374 million patients suffering from osteoarthritis worldwide,” said Luc Boblet , CEO of 4MB . Founded in 2020, 4MB has now received approximately €30 million in total funding to date, combining private financing and non-dilutive public support. This trajectory illustrates a strong long-term strategy led by 4P-Pharma and built on its proprietary drug regeneration model, addressing untreated serious diseases and implemented independently by each of its subsidiaries. “The arrival of new investors in 4MB reflects the strength and coherence of the 4P-Pharma group’s platform, built on disciplined capital allocation and scientific rigor,” added Revital Rattenbach , CEO of 4P-Pharma and co-founder of 4MB . “By enabling our subsidiaries to independently define and execute their own trajectories, 4P-Pharma demonstrates the relevance of its start-up studio model.” In the coming months, 4MB will focus on executing its clinical strategy in preparation for future regulatory agency interactions and on facilitating patient access to its molecule for those who need it most. 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:  LinkedIn: X : Contacts Press Emmanuel Dadjé Communication Manager Email : Emmanuel.dadje@4P-pharma.com Phone : +33 6 30 06 12 13