{"success":true,"data":{"pressRelease":{"id":"143065","rtpr_id":"nGNX5ft0qs-20260914","ticker":"AGMB","exchange":"NASDAQ","all_tickers":["AGMB"],"title":"Agomab Announces Positive Phase 1 Results for AGMB-447 in Patients with Idiopathic Pulmonary Fibrosis and Design of Phase 2 INSPIRIA Study","author":"Globe Newswire","published_at":"2026-09-14T20:05:00.623Z","article_body":"-- Topline Phase 1 data shows generally favorable safety and tolerability\nprofile of AGMB-447 --\n\n-- Pharmacokinetic profile confirms efficient lung restriction with low\nsystemic exposure and high exposure of AGMB-447 in the lung, in line with\nprior results observed in healthy participants --\n\n-- Robust target engagement of ALK5 observed with AGMB-447 in IPF patients --\n\n-- Clinical Trial Application (CTA) for INSPIRIA Phase 2 study in IPF patients\nsubmitted; Company intends to initiate study before year-end --\n\nAntwerp, Belgium, September 14, 2026 – Agomab Therapeutics NV\n(https://www.globenewswire.com/Tracker?data=EQjrOlyHK9KpUpnQbKLHbLm8HkNnXpdhB1unk1wmxliUsRqlp3OboP1x19gwyopKSm5hU-iMi0T5l-Rl4SB9uRlZnvRggjy2Sixy42EGdok=)\n(‘Agomab’), a clinical-stage biopharmaceutical company focused on\nfibro-inflammation, today announced positive results of the Phase 1 study of\nAGMB-447 in IPF patients. AGMB-447 is an investigational inhaled\nlung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the\ntreatment of Idiopathic Pulmonary Fibrosis (IPF).(1)\n\nThe Phase 1 study of AGMB-447 is a three-part, double-blind, randomized,\nplacebo-controlled single ascending dose (SAD; Part A; dose range: 1 mg QD\n(once daily) to 20 mg QD) and multiple ascending dose (MAD; Part B; dose\nrange: 1 mg QD to 6 mg BID (twice daily)) study in healthy participants and\nmultiple dose study in IPF patients (Part C; dose range: 4.5 mg BID to 6 mg\nBID). AGMB-447 was administered via nebulization, as a single dose in the SAD,\nover seven days in Part B and over 14 days in Part C.\n\nA total of 10 IPF patients were included in Part C. In line with the data in\nhealthy participants reported previously, AGMB-447 was observed to have a\ngenerally favorable safety and tolerability profile in IPF patients at 4.5 mg\nBID. While a higher incidence of adverse events was reported at 6 mg BID, no\nnew specific safety signals were identified, and no systemic safety signals\nwere detected at any dose. The most frequently reported adverse events were\ncough and bronchospasm. Cough episodes were short and mostly limited to the\ninhalation period. Furthermore, no increase in the severity of disease-related\ncough was reported at any dose over the 14-day dosing period.\n\nLow systemic but high pulmonary exposure of AGMB-447 was also measured in IPF\npatients, supporting its lung-restricted pharmacokinetic (PK) profile. In IPF\npatients, daily doses of 4.5 mg BID achieved average bronchoalveolar lavage\n(BAL) fluid levels above IC(90) for at least 6 hours post-inhalation, and\nabove IC(50) for 24 hours, in line with the PK profile observed in healthy\nparticipants.\n\nIn IPF patients, pSMAD3 reduction in BAL cells of >50% was achieved at the 4.5\nmg BID dose, indicating robust target engagement in line with the results\nobserved previously in healthy participants and supporting further clinical\ndevelopment of AGMB-447 for the treatment of IPF.\n\n“We are very pleased with the Phase 1 results of AGMB-447 in patients with\nIPF announced today. In line with the positive interim data in healthy\nparticipants announced earlier this year, the data indicated a generally\nfavorable safety, tolerability and PK profile of AGMB-447 and provided\nproof-of-mechanism of TGFβ/ALK5 inhibition in the lungs of IPF patients,”\nsaid Philippe Wiesel, Chief Medical Officer at Agomab. “We believe that by\nblocking the TGFβ/ALK5 pathway locally in the lung, AGMB-447 has the\npotential to offer a potent anti-fibrotic therapy to IPF patients. The\nextensive data collected in our broad Phase 1 program supports the initiation\nof our Phase 2 INSPIRIA study later this year.”\n\nThe company also announced the design of INSPIRIA, its planned Phase 2 study\nwith AGMB-447 in IPF. INSPIRIA is a 24-week Phase 2, randomized, double-blind,\nplacebo-controlled study in approximately 120 patients with confirmed IPF.\nPatients will be randomized 2:1 to receive AGMB-447 4 mg twice daily or\nplacebo, administered by inhalation on top of standard of care. The study is\ndesigned to evaluate the safety, pharmacokinetics and efficacy of AGMB-447 in\nIPF patients. The primary endpoint will be the change from baseline in forced\nvital capacity at Week 24. The CTA for INSPIRIA has been submitted, and the\nstudy is anticipated to begin in the second half of 2026 across a large\nEuropean site network.\n\n“We have long known that the TGFβ pathway is a central driver of fibrosis\nin IPF. Targeting this key pathway through ALK5 inhibition with AGMB-447 is a\npromising approach. With a convenient twice-daily dosing schedule, AGMB-447\ncould represent an attractive option for monotherapy or combination therapy\nwith systemic standard of care therapies. The INSPIRIA study is designed to\nfurther explore the therapeutic potential of this novel inhaled approach in\npeople living with IPF,” said Toby Maher, M.D., PhD, Professor of Clinical\nMedicine at Keck School of Medicine of USC.\n\nAgomab intends to present detailed Phase 1 results at a future scientific\nconference.\n\nAGMB-447 is an investigational drug and not approved by any regulatory\nauthority. Its efficacy and safety have not been established. \n\nAbout IPF\nIdiopathic Pulmonary Fibrosis (IPF) is a devastating disease affecting\napproximately 255,000 patients in the U.S., Japan, and the largest European\nmarkets (EU4+UK). IPF is characterized by unregulated production of fibrotic,\nscar-like tissue that builds up in the scaffolding of the lungs. As a result,\nthe fibrotic lung becomes stiff, hampers the patient’s ability to breathe\nand reduces the absorption of inhaled oxygen in the blood. Despite the\ncommercial availability of three approved therapies, without a lung\ntransplant, the median survival following diagnosis is only 3-5 years.\nMoreover, these therapies do not halt but only slow down disease progression\nand have side effects that reduce tolerability and lead to treatment\ndiscontinuations.\n\nAbout AGMB-447\nAGMB-447 is an inhaled lung-restricted small molecule inhibitor of ALK5 (or\nTGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF).\nTGFβ is the master regulator of fibrosis, which is the key mechanism driving\nIPF disease progression. AGMB-447 is specifically designed to inhibit ALK5 in\nthe lung while avoiding clinically relevant systemic exposure through local\nadministration via inhalation and rapid hydrolyzation in plasma into one main\nmetabolite inactive in cells. Through AGMB-447, Agomab aims to offer a\npotentially safe and effective novel anti-fibrotic therapeutic option to IPF\npatients.\n\nAbout Agomab\nAgomab is a clinical-stage biopharmaceutical company focused on developing\nnovel disease-modifying therapies for fibro-inflammatory diseases with high\nunmet medical need. Agomab’s product candidates are designed to target\nestablished, potent pathways and utilize organ-restricted approaches, with\nthe aim of increasing efficacy while minimizing safety liabilities. Fostering\na culture of excellence, Agomab’s mission is to pioneer therapeutics that\naim to resolve fibro-inflammation and restore organ function to enable people\nwith these disorders to live fuller and healthier lives.\n\nCautionary Note regarding Forward-Looking Statements\nThis press release includes certain disclosures that contain \"forward-looking\nstatements\" within the meaning of Section 27A of the Securities Act of 1933,\nas amended, and Section 21E of the Securities Exchange Act of 1934, as\namended. Forward-looking statements are often identified by terms such as\n\"continue,\" \"anticipate,\" \"believe,\" \"could,\" \"estimate,\" \"expect,\" \"goal,\"\n\"intend,\" \"look forward to,\" \"may,\" \"plan,\" \"potential,\" \"predict,\" \"project,\"\n\"should,\" \"will,\" \"would\" and similar expressions. “Forward-looking\nstatements” include, without limitation, statements regarding the potential\nof AGMB-447 for the treatment of IPF, the design of the planned Phase 2\nclinical trial with AGMB-447 for IPF, our expectation to initiate our Phase 2\nclinical trial of AGMB-447 in IPF in the second half of 2026, and our\ninteractions with regulatory authorities. Forward-looking statements are based\non Agomab’s current expectations and are subject to inherent uncertainties,\nrisks and assumptions that are difficult to predict. Factors that could cause\nactual results to differ include, but are not limited to, risks and\nuncertainties related to the results of our clinical trials; expectations\nregarding the inherent uncertainties associated with the development of novel\ndrug therapies; preclinical and clinical trial and product development\nactivities and regulatory approval requirements for product candidates; the\nimpact of governmental laws and regulations on our business; and disruptions\ncaused by our reliance on third party suppliers and service providers. These\nand other risks and uncertainties are described more fully in our filings and\nreports with the SEC, including in our most recent annual report on Form\n20‐F filed with the SEC and our subsequent filings and reports filed with\nthe SEC. Forward-looking statements contained in this announcement are made as\nof this date, and Agomab undertakes no duty to update such information except\nas required under applicable law. Readers should not rely upon the information\nin this announcement as current or accurate after its publication date.\n\nContacts\nInvestors\nSofie Van Gijsel\nVP of Investor Relations\nE-Mail: sofie.vangijsel@agomab.com\nPhone: +1 781 296 1143\n        \nMedia\nGretchen Schweitzer\nTrophic Communications\nE-Mail: agomab@trophic.eu \nPhone: +49 172 861 8540\n\n(1) Study Details | Phase I Study to Assess Safety, Tolerability, PK and PD of\nAGMB-447 in Healthy Participants and Participants With IPF |\nClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=TjMvc40RAw8gqLKdtzwTFE4SHxtOvqqL9gGI9whiZZ3H-BpAsme0kF4UBn2KNUhqFBT0VwS0lU9YTYe84DWqwlGxOTif5KHu6g7XdEV3kuZWK4mrm6vqG8oXp1yhn4FZ4TunBHsvvqQcmPU8zPFuK53NOyly7R3Sb63d1Q5YRjlqmranBnhNTTsRbqI24F0W6EsY1_S9nJtHVjgIzxPnNFbr-VfNtGGZ4GlFSi-r7gSQj16B2UdaxDbCtRwK2vWpXMrCvMdZ9OSA5CBs-FKO3xhp-jedVoV4tkdnEH3BZYCGZGzy7COhy4Ko0RhQ4CRBHsOE5cE0ilsviuDJ36lqrFiDhcDpudXr54_Y6Md0Fx0=)\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/7f797bcb-5d5d-4fb6-a862-b5c861b83e54)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX5ft0qs-20260914","title":"Agomab Announces Positive Phase 1 Results for AGMB-447 in Patients with Idiopathic Pulmonary Fibrosis and Design of Phase 2 INSPIRIA Study","author":"Globe Newswire","ticker":"AGMB","created":"2026-09-14T20:05:00.623Z","tickers":["AGMB"],"exchange":"NASDAQ","article_body":"-- Topline Phase 1 data shows generally favorable safety and tolerability\nprofile of AGMB-447 --\n\n-- Pharmacokinetic profile confirms efficient lung restriction with low\nsystemic exposure and high exposure of AGMB-447 in the lung, in line with\nprior results observed in healthy participants --\n\n-- Robust target engagement of ALK5 observed with AGMB-447 in IPF patients --\n\n-- Clinical Trial Application (CTA) for INSPIRIA Phase 2 study in IPF patients\nsubmitted; Company intends to initiate study before year-end --\n\nAntwerp, Belgium, September 14, 2026 – Agomab Therapeutics NV\n(https://www.globenewswire.com/Tracker?data=EQjrOlyHK9KpUpnQbKLHbLm8HkNnXpdhB1unk1wmxliUsRqlp3OboP1x19gwyopKSm5hU-iMi0T5l-Rl4SB9uRlZnvRggjy2Sixy42EGdok=)\n(‘Agomab’), a clinical-stage biopharmaceutical company focused on\nfibro-inflammation, today announced positive results of the Phase 1 study of\nAGMB-447 in IPF patients. AGMB-447 is an investigational inhaled\nlung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the\ntreatment of Idiopathic Pulmonary Fibrosis (IPF).(1)\n\nThe Phase 1 study of AGMB-447 is a three-part, double-blind, randomized,\nplacebo-controlled single ascending dose (SAD; Part A; dose range: 1 mg QD\n(once daily) to 20 mg QD) and multiple ascending dose (MAD; Part B; dose\nrange: 1 mg QD to 6 mg BID (twice daily)) study in healthy participants and\nmultiple dose study in IPF patients (Part C; dose range: 4.5 mg BID to 6 mg\nBID). AGMB-447 was administered via nebulization, as a single dose in the SAD,\nover seven days in Part B and over 14 days in Part C.\n\nA total of 10 IPF patients were included in Part C. In line with the data in\nhealthy participants reported previously, AGMB-447 was observed to have a\ngenerally favorable safety and tolerability profile in IPF patients at 4.5 mg\nBID. While a higher incidence of adverse events was reported at 6 mg BID, no\nnew specific safety signals were identified, and no systemic safety signals\nwere detected at any dose. The most frequently reported adverse events were\ncough and bronchospasm. Cough episodes were short and mostly limited to the\ninhalation period. Furthermore, no increase in the severity of disease-related\ncough was reported at any dose over the 14-day dosing period.\n\nLow systemic but high pulmonary exposure of AGMB-447 was also measured in IPF\npatients, supporting its lung-restricted pharmacokinetic (PK) profile. In IPF\npatients, daily doses of 4.5 mg BID achieved average bronchoalveolar lavage\n(BAL) fluid levels above IC(90) for at least 6 hours post-inhalation, and\nabove IC(50) for 24 hours, in line with the PK profile observed in healthy\nparticipants.\n\nIn IPF patients, pSMAD3 reduction in BAL cells of >50% was achieved at the 4.5\nmg BID dose, indicating robust target engagement in line with the results\nobserved previously in healthy participants and supporting further clinical\ndevelopment of AGMB-447 for the treatment of IPF.\n\n“We are very pleased with the Phase 1 results of AGMB-447 in patients with\nIPF announced today. In line with the positive interim data in healthy\nparticipants announced earlier this year, the data indicated a generally\nfavorable safety, tolerability and PK profile of AGMB-447 and provided\nproof-of-mechanism of TGFβ/ALK5 inhibition in the lungs of IPF patients,”\nsaid Philippe Wiesel, Chief Medical Officer at Agomab. “We believe that by\nblocking the TGFβ/ALK5 pathway locally in the lung, AGMB-447 has the\npotential to offer a potent anti-fibrotic therapy to IPF patients. The\nextensive data collected in our broad Phase 1 program supports the initiation\nof our Phase 2 INSPIRIA study later this year.”\n\nThe company also announced the design of INSPIRIA, its planned Phase 2 study\nwith AGMB-447 in IPF. INSPIRIA is a 24-week Phase 2, randomized, double-blind,\nplacebo-controlled study in approximately 120 patients with confirmed IPF.\nPatients will be randomized 2:1 to receive AGMB-447 4 mg twice daily or\nplacebo, administered by inhalation on top of standard of care. The study is\ndesigned to evaluate the safety, pharmacokinetics and efficacy of AGMB-447 in\nIPF patients. The primary endpoint will be the change from baseline in forced\nvital capacity at Week 24. The CTA for INSPIRIA has been submitted, and the\nstudy is anticipated to begin in the second half of 2026 across a large\nEuropean site network.\n\n“We have long known that the TGFβ pathway is a central driver of fibrosis\nin IPF. Targeting this key pathway through ALK5 inhibition with AGMB-447 is a\npromising approach. With a convenient twice-daily dosing schedule, AGMB-447\ncould represent an attractive option for monotherapy or combination therapy\nwith systemic standard of care therapies. The INSPIRIA study is designed to\nfurther explore the therapeutic potential of this novel inhaled approach in\npeople living with IPF,” said Toby Maher, M.D., PhD, Professor of Clinical\nMedicine at Keck School of Medicine of USC.\n\nAgomab intends to present detailed Phase 1 results at a future scientific\nconference.\n\nAGMB-447 is an investigational drug and not approved by any regulatory\nauthority. Its efficacy and safety have not been established. \n\nAbout IPF\nIdiopathic Pulmonary Fibrosis (IPF) is a devastating disease affecting\napproximately 255,000 patients in the U.S., Japan, and the largest European\nmarkets (EU4+UK). IPF is characterized by unregulated production of fibrotic,\nscar-like tissue that builds up in the scaffolding of the lungs. As a result,\nthe fibrotic lung becomes stiff, hampers the patient’s ability to breathe\nand reduces the absorption of inhaled oxygen in the blood. Despite the\ncommercial availability of three approved therapies, without a lung\ntransplant, the median survival following diagnosis is only 3-5 years.\nMoreover, these therapies do not halt but only slow down disease progression\nand have side effects that reduce tolerability and lead to treatment\ndiscontinuations.\n\nAbout AGMB-447\nAGMB-447 is an inhaled lung-restricted small molecule inhibitor of ALK5 (or\nTGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF).\nTGFβ is the master regulator of fibrosis, which is the key mechanism driving\nIPF disease progression. AGMB-447 is specifically designed to inhibit ALK5 in\nthe lung while avoiding clinically relevant systemic exposure through local\nadministration via inhalation and rapid hydrolyzation in plasma into one main\nmetabolite inactive in cells. Through AGMB-447, Agomab aims to offer a\npotentially safe and effective novel anti-fibrotic therapeutic option to IPF\npatients.\n\nAbout Agomab\nAgomab is a clinical-stage biopharmaceutical company focused on developing\nnovel disease-modifying therapies for fibro-inflammatory diseases with high\nunmet medical need. Agomab’s product candidates are designed to target\nestablished, potent pathways and utilize organ-restricted approaches, with\nthe aim of increasing efficacy while minimizing safety liabilities. Fostering\na culture of excellence, Agomab’s mission is to pioneer therapeutics that\naim to resolve fibro-inflammation and restore organ function to enable people\nwith these disorders to live fuller and healthier lives.\n\nCautionary Note regarding Forward-Looking Statements\nThis press release includes certain disclosures that contain \"forward-looking\nstatements\" within the meaning of Section 27A of the Securities Act of 1933,\nas amended, and Section 21E of the Securities Exchange Act of 1934, as\namended. Forward-looking statements are often identified by terms such as\n\"continue,\" \"anticipate,\" \"believe,\" \"could,\" \"estimate,\" \"expect,\" \"goal,\"\n\"intend,\" \"look forward to,\" \"may,\" \"plan,\" \"potential,\" \"predict,\" \"project,\"\n\"should,\" \"will,\" \"would\" and similar expressions. “Forward-looking\nstatements” include, without limitation, statements regarding the potential\nof AGMB-447 for the treatment of IPF, the design of the planned Phase 2\nclinical trial with AGMB-447 for IPF, our expectation to initiate our Phase 2\nclinical trial of AGMB-447 in IPF in the second half of 2026, and our\ninteractions with regulatory authorities. Forward-looking statements are based\non Agomab’s current expectations and are subject to inherent uncertainties,\nrisks and assumptions that are difficult to predict. Factors that could cause\nactual results to differ include, but are not limited to, risks and\nuncertainties related to the results of our clinical trials; expectations\nregarding the inherent uncertainties associated with the development of novel\ndrug therapies; preclinical and clinical trial and product development\nactivities and regulatory approval requirements for product candidates; the\nimpact of governmental laws and regulations on our business; and disruptions\ncaused by our reliance on third party suppliers and service providers. These\nand other risks and uncertainties are described more fully in our filings and\nreports with the SEC, including in our most recent annual report on Form\n20‐F filed with the SEC and our subsequent filings and reports filed with\nthe SEC. Forward-looking statements contained in this announcement are made as\nof this date, and Agomab undertakes no duty to update such information except\nas required under applicable law. Readers should not rely upon the information\nin this announcement as current or accurate after its publication date.\n\nContacts\nInvestors\nSofie Van Gijsel\nVP of Investor Relations\nE-Mail: sofie.vangijsel@agomab.com\nPhone: +1 781 296 1143\n        \nMedia\nGretchen Schweitzer\nTrophic Communications\nE-Mail: agomab@trophic.eu \nPhone: +49 172 861 8540\n\n(1) Study Details | Phase I Study to Assess Safety, Tolerability, PK and PD of\nAGMB-447 in Healthy Participants and Participants With IPF |\nClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=TjMvc40RAw8gqLKdtzwTFE4SHxtOvqqL9gGI9whiZZ3H-BpAsme0kF4UBn2KNUhqFBT0VwS0lU9YTYe84DWqwlGxOTif5KHu6g7XdEV3kuZWK4mrm6vqG8oXp1yhn4FZ4TunBHsvvqQcmPU8zPFuK53NOyly7R3Sb63d1Q5YRjlqmranBnhNTTsRbqI24F0W6EsY1_S9nJtHVjgIzxPnNFbr-VfNtGGZ4GlFSi-r7gSQj16B2UdaxDbCtRwK2vWpXMrCvMdZ9OSA5CBs-FKO3xhp-jedVoV4tkdnEH3BZYCGZGzy7COhy4Ko0RhQ4CRBHsOE5cE0ilsviuDJ36lqrFiDhcDpudXr54_Y6Md0Fx0=)\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/7f797bcb-5d5d-4fb6-a862-b5c861b83e54)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-14T20:05:00.673840556Z","server_sent_at_ms":1789416300673},"received_at":"2026-09-14T20:05:00.730Z","source_url":null},"analysis":{"id":"131895","press_release_id":"143065","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Higher incidence of adverse events at 6 mg BID; cough and bronchospasm were the most frequently reported events","IPF cohort was small (10 patients) with only 14 days of dosing; target engagement shown but no efficacy data yet","AGMB-447 is investigational and not approved by any regulatory authority; efficacy and safety not established"],"eventType":"clinical_trial","narrative":"Agomab Therapeutics announced positive Phase 1 results for AGMB-447, its inhaled lung-restricted ALK5 (TGFβR1) inhibitor for idiopathic pulmonary fibrosis, with a generally favorable safety and tolerability profile in IPF patients at 4.5 mg twice daily.\n\nPharmacokinetics confirmed low systemic exposure with high lung exposure, and pSMAD3 reduction in BAL cells exceeded 50% at the 4.5 mg BID dose, demonstrating robust target engagement; higher adverse-event rates at 6 mg BID (mainly cough and bronchospasm) raised no new safety signals.\n\nThe company also disclosed the design of the Phase 2 INSPIRIA study: a 24-week, randomized, placebo-controlled trial in approximately 120 IPF patients with change in forced vital capacity at Week 24 as the primary endpoint, with the CTA submitted and initiation expected in the second half of 2026.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Positive Phase 1 proof-of-mechanism for AGMB-447 de-risks Agomab's IPF lead and sets up Phase 2 INSPIRIA initiation before year-end."},"keyFigures":{"drugName":"AGMB-447","phaseOfTrial":"Phase 1 (Part C in IPF patients); Phase 2 INSPIRIA designed","customDimensions":{"bal_levels":"above IC90 for at least 6 hours post-inhalation and above IC50 for 24 hours at 4.5 mg BID","phase2_patients":"approximately 120","psmad3_reduction":">50%","phase2_initiation":"second half of 2026, CTA submitted","phase1_ipf_patients":10,"phase2_randomization":"2:1 AGMB-447 4 mg BID vs placebo, inhaled on top of standard of care","phase2_duration_weeks":24,"ipf_patient_population":"approximately 255,000 in U.S., Japan, and EU4+UK","phase2_primary_endpoint":"change from baseline in forced vital capacity at Week 24"}},"quotedText":"proof-of-mechanism of TGFβ/ALK5 inhibition in the lungs of IPF patients","namedEntities":{"people":[{"name":"Philippe Wiesel","role":"Chief Medical Officer at Agomab"},{"name":"Toby Maher, M.D., PhD","role":"Professor of Clinical Medicine at Keck School of Medicine of USC (external expert)"}],"products":["AGMB-447","INSPIRIA (Phase 2 study)"],"companies":[{"name":"Agomab Therapeutics NV","ticker":"AGMB","relationship":"filer"},{"name":"Keck School of Medicine of USC","relationship":"academic institution / external expert source"},{"name":"Trophic Communications","relationship":"media relations agency"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive Phase 1 proof-of-mechanism data for the company's clinical lead in IPF, with robust ALK5 target engagement (>50% pSMAD3 reduction) and a Phase 2 INSPIRIA study design unveiled with CTA submitted. Meaningful pipeline de-risking, but early-stage: only 10 IPF patients dosed for 14 days and no efficacy data, so not a binary or market-moving catalyst."},"tickerRelevance":{"others":[],"primary":"AGMB"},"globalImportance":30,"audienceRelevance":28,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap clinical-stage biotech","dataMaturity":"early-stage (10 IPF patients, 14-day dosing, no efficacy endpoints)","eventGravity":"positive Phase 1 readout plus Phase 2 design/CTA submission","sectorWeight":"biotech clinical catalyst","retailFavoriteBoost":"moderate — biotech retail follows clinical catalysts closely but AGMB is a niche name"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Agomab Therapeutics announced positive Phase 1 results for AGMB-447, its inhaled lung-restricted ALK5 (TGFβR1) inhibitor for idiopathic pulmonary fibrosis, with a generally favorable safety and tolerability profile in IPF patients at 4.5 mg twice daily.\n\nPharmacokinetics confirmed low systemic exposure with high lung exposure, and pSMAD3 reduction in BAL cells exceeded 50% at the 4.5 mg BID dose, demonstrating robust target engagement; higher adverse-event rates at 6 mg BID (mainly cough and bronchospasm) raised no new safety signals.\n\nThe company also disclosed the design of the Phase 2 INSPIRIA study: a 24-week, randomized, placebo-controlled trial in approximately 120 IPF patients with change in forced vital capacity at Week 24 as the primary endpoint, with the CTA submitted and initiation expected in the second half of 2026.","key_figures":{"drugName":"AGMB-447","phaseOfTrial":"Phase 1 (Part C in IPF patients); Phase 2 INSPIRIA designed","customDimensions":{"bal_levels":"above IC90 for at least 6 hours post-inhalation and above IC50 for 24 hours at 4.5 mg BID","phase2_patients":"approximately 120","psmad3_reduction":">50%","phase2_initiation":"second half of 2026, CTA submitted","phase1_ipf_patients":10,"phase2_randomization":"2:1 AGMB-447 4 mg BID vs placebo, inhaled on top of standard of care","phase2_duration_weeks":24,"ipf_patient_population":"approximately 255,000 in U.S., Japan, and EU4+UK","phase2_primary_endpoint":"change from baseline in forced vital capacity at Week 24"}},"named_entities":{"people":[{"name":"Philippe Wiesel","role":"Chief Medical Officer at Agomab"},{"name":"Toby Maher, M.D., PhD","role":"Professor of Clinical Medicine at Keck School of Medicine of USC (external expert)"}],"products":["AGMB-447","INSPIRIA (Phase 2 study)"],"companies":[{"name":"Agomab Therapeutics NV","ticker":"AGMB","relationship":"filer"},{"name":"Keck School of Medicine of USC","relationship":"academic institution / external expert source"},{"name":"Trophic Communications","relationship":"media relations agency"}],"dollarAmounts":[]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-14T20:06:13.576Z","global_importance":30,"audience_relevance":28,"importance_components":{"tickerTier":"small-cap clinical-stage biotech","dataMaturity":"early-stage (10 IPF patients, 14-day dosing, no efficacy endpoints)","eventGravity":"positive Phase 1 readout plus Phase 2 design/CTA submission","sectorWeight":"biotech clinical catalyst","retailFavoriteBoost":"moderate — biotech retail follows clinical catalysts closely but AGMB is a niche name"}},"durationMs":36710,"modelName":"glm-5.3-flash"}}