<img src="https://ml.globenewswire.com/Resource/Download/fedc15bc-0f40-4b0f-9fc4-37d86c562fbd?size=2" nborder="0" align="left" hspace="5" vspace="5" title="intrommune_icon_500x500.png" alt="Intrommune Therapeutics"/>Exploratory data from the OMEGA Phase 1 trial suggests that OMIT with INT301 delivered via toothpaste should be studied further.NEW YORK, June 12, 2026 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a clinical-stage biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, today announced the presentation of exploratory efficacy data from the Oral Mucosal Escalation Goal Assessment (OMEGA) Phase 1 safety trial at the 2026 Eastern Allergy Conference (EAC) in Palm Beach, Florida. In an exploratory analysis of a subset of participants who completed 48 weeks of treatment in the double-blind, placebo-controlled OMEGA trial, 100% of INT301-treated participants (n=3) tolerated ≥600 mg of peanut protein—equivalent to approximately 2–2.5 peanut kernels—representing a ≥50-fold increase from a baseline median eliciting dose of 12 mg. Peanut tolerance was objectively measured using the gold standard for clinical reactivity, the double-blind, placebo-controlled food challenge (DBPCFC), at both baseline and study exit. Exploratory endpoints are intended only to support new hypothesis generation and should not be used to draw any conclusions about actual or potential clinical efficacy. "We are particularly excited that these results were obtained in an adult population, a group that is generally considered more difficult to treat with food allergy immunotherapy. The observations of INT301 along with our previously disclosed exploratory data in IgG4 reinforce our conviction that this data deserves further study, and we look forward to investigating this further in larger trials," said Michael Nelson, Chief Executive Officer, Intrommune Therapeutics, Inc. About Peanut and Other Food Allergies Food allergies affect more than 220 million people worldwide, including approximately 33 million people in the United States. Management of food allergies currently focuses on avoidance of exposure to triggering foods, though often such foods, including peanuts, are common ingredients in food products and therefore difficult to avoid. Many people with peanut allergy are accidentally exposed and experience potentially life-threatening reactions, including anaphylaxis, each year. Unfortunately, food allergy remains an area of tremendous unmet medical need. About Oral Mucosal Immunotherapy™ The goal of Oral Mucosal Immunotherapy (OMIT) is to utilize complex patented biochemical processes to stabilize and deliver allergenic proteins in a fully functional toothpaste. Success with allergy immunotherapy hinges on consistent exposure of a patient’s immune system to gradually “desensitize” the patient to the specific allergy trigger over time. OMIT may offer targeted delivery and simplified administration while a patient simply brushes their teeth, which supports the potential for improved adherence. "Adherence is one of the greatest challenges in food allergy immunotherapy, and existing approaches place a significant burden on patients and families. The concept of potentially integrating allergen delivery into something as routine as tooth brushing is elegantly simple and easily portable,” commented Edmond Chan, MD, Head, Division of Allergy, Department of Pediatrics, University of British Columbia, who plans on running real-world studies of OMIT. Significance The OMEGA Phase 1 safety trial previously reported on the safety, tolerability and adherence of OMIT with INT301 (Read a ‘Randomized, Placebo-Controlled Phase 1 Safety Study of Oral Mucosal Immunotherapy in Peanut Allergic Adults’ by clicking <a href="https://www.globenewswire.com/Tracker?data=uetECgjduSHn4WIFEBjDiPnV3pj7peBlUrzIw62nvM8BzWMLe33emah7IXCCvR0NsaZgaNUbIdAi9aa6_HgMgmrGmhYalEIwGP0Sp2_4e2R4T8uJW4Ia9VNugMP5Da-QrExh--MukHbY-X6mBD3w3A==" rel="nofollow" target="_blank" title="">here.</a>) These exploratory findings presented at the 2026 Eastern Allergy Conference suggest that OMIT with INT301 warrants further investigation in large scale clinical trials. “Although this was a small exploratory analysis, this data strongly justifies progression to larger efficacy trials adequately powered to fully characterize the potential of OMIT," stated Jeffrey Weiss, MD, one of the principal investigators in the OMEGA Phase 1 study. About Intrommune Therapeutics Intrommune Therapeutics is a clinical-stage biotechnology company dedicated to developing safe, effective and easy-to-use food exposure products that support patients and families across every stage of food allergy management, from prevention to the treatment of food allergies. Our approach integrates three core pillars: supporting early allergen introduction in at-risk infants and children, advancing OMIT to provide new treatment options for those living with food allergy, and empowering physicians with versatile solutions offering customized patient care. Intrommune is developing the revolutionary OMIT treatment platform for food allergies, leveraging the oral mucosa’s immunologic properties to deliver targeted immunomodulation via a fully-functional toothpaste. OMIT is a potential patient-friendly solution for over 220 million people worldwide, including 33 million people in the United States, who suffer from life-altering food allergies. Conference Details: Conference: 2026 Eastern Allergy Conference (EAC) Session Date: Saturday, May 30, 2026 Presenter: Michael Nelson, CEO Location: Palm Beach, Florida For more information on Intrommune Therapeutics, please visit <a href="https://www.globenewswire.com/Tracker?data=0IztqekzDuiFyx2UUZUzI-Dx3eLBkl301BEz2LebD5fAtgGvHELTfEUxhUHgyB5wAA-FMNQUDYC4wgnwvYdHQ-7ND0DA-nl-AESslbTsZrs=" rel="nofollow" target="_blank" title="www.intrommune.com">www.intrommune.com</a> Contact: Dr. Erick Berglund Chief Science Officer, Intrommune Therapeutics, Inc. 617-663-8725 EBerglund@intrommune.com Cautionary Statement Regarding Forward Looking Statements This release may contain “forward-looking statements.” Forward-looking statements are identified by certain words or phrases such as “may,” “will,” “aim,” “will likely result,” “believe,” “expect,” “will continue,” “anticipate,” “estimate,” “intend,” “plan,” “contemplate,” “seek to,” “future,” “objective,” “goal,” “project,” “should,” “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release. This release does not contain or constitute an offer to sell or a solicitation of any offer to buy securities in the United States or in any other jurisdiction. <img alt="" src='https://ml.globenewswire.com/media/MmQwNzMyN2EtMDZkNy00MDA3LTk0YjYtNTAyYTRhMTVjZDMxLTEwNDA0NDEtMjAyNi0wNi0xMi1lbg==/tiny/Intrommune-Therapeutics.png' referrerpolicy='no-referrer-when-downgrade' />

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Exploratory Efficacy Data Suggests Further Study of Peanut Tolerance with Oral Mucosal Immunotherapy (OMIT)

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