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Intrommune Announces Expanded Scope of Phase 1 OMEGA Study in Adults with Peanut AllergyAmendment to Extend Study Duration to 48 weeks New Maintenance Period Is Designed to Evaluate Safety of INT301 After Long-term Exposure NEW YORK, June 22, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology company developing a patient-friendly treatment platform for peanut and other food allergies, today announced an amendment to its ongoing Phase 1 OMEGA Clinical Study of INT301 in adult patients with peanut allergy. The amendment increases the study duration for patients to 48 weeks to include a maintenance period. This maintenance period allows for the evaluation of safety after long term use of INT301. Additionally, the amendment allows for the inclusion of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC) at the end of treatment. The OMEGA Phase 1 Clinical Trial, including the initial results of the DBPCOFC, will inform the dosing regimen and design of future clinical studies. INT301 is a novel peanut desensitization immunotherapy formulated as a fully-functioning toothpaste conveniently administered during a patient’s daily toothbrushing routine. “We continue to make steady progress in the clinical development of INT301 for peanut allergy. We are encouraged by the FDA clearance of this amendment to our ongoing Phase 1 OMEGA Clinical Study, which will now include an evaluation of the long-term safety of INT301 in peanut allergic adults and inform the design of future studies,” said Michael Nelson, CEO, Intrommune Therapeutics. “We are encouraged that most patients remaining in Cohort 2 and Cohort 3 when we received this allowance from the FDA consented to maintenance dosing, even though this requires undergoing an additional oral food challenge. The support and interest we have received from patients and physicians has reassured us that we are developing a product that patients need and want.” Intrommune Therapeutic’s Phase 1 OMEGA Clinical Study is a randomized, double-blind, placebo-controlled study that enrolls adults with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. Cohort 1 patients stared at the lowest dose and were titrated through four increasing doses of INT301. The study groups are blinded to the investigator, patients, and the Intrommune study team. Earlier this year the FDA allowed an amendment to the OMEGA Clinical Study to determine Maximally Tolerated Dose in Cohorts 2 through 4. Cohort 3 is fully enrolled, and to date, no patient on Cohort 1 through 3 has had a significant or even moderate adverse event that is related to the study treatment. All study-related adverse events have been mild and transient. Based on pre-specified criteria, including the safety profile of patients enrolled in Cohorts 1 through 3, the internal Safety Monitoring Committee approved the opening of Cohort 4, starting patients at Dose 4. Phase 1 is designed to help ascertain the highest safe starting dose, which may shorten the up-titration period required to reach INT301 maintenance dosing, reduce the number of office visits required and making the most convenient immunotherapy option even more convenient. About Peanut and Other Food Allergies About Oral Mucosal Immunotherapy™ About Intrommune Therapeutics For more information on Intrommune Therapeutics, please visit http://www.intrommune.com Contact: 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. |