Melbourne, Australia – May 15, 2026
Atisama Therapeutics, formerly known as Rage Bio, announced significant progress in the ongoing Phase 1 clinical trial of its lead splice-switching oligonucleotide (SSO) therapy candidate RB042, while also strengthening corporate leadership through the appointment of Bernard Coulie as Chair of the Board of Directors. The Australian clinical-stage biotechnology company is focused on developing next-generation therapies targeting chronic inflammatory diseases using a differentiated SSO platform designed to regulate disease-driving genetic isoforms. According to the company, the RB042 Phase 1 study has successfully progressed from single ascending dose (SAD) cohorts into multiple ascending dose (MAD) cohorts after demonstrating encouraging safety and tolerability results in healthy volunteers and healthy smokers. Atisama stated that the advancement marks an important milestone as the company prepares for later-stage clinical development of its inhaled therapy program targeting respiratory inflammatory diseases.
RB042 Advances Into Multiple Ascending Dose Cohorts
The ongoing RB042_1001 Phase 1 study (NCT07285122) is evaluating the safety, tolerability, and early biological activity of RB042 in healthy participants. Three out of four planned SAD cohorts have been completed successfully, while the first MAD cohort has now been initiated. The company expects higher-dose cohort data to become available during the second half of 2026. RB042 is an inhaled splice-switching oligonucleotide therapy designed to selectively downregulate harmful inflammatory isoforms while simultaneously increasing protective counterparts, creating a dual-action therapeutic mechanism that Atisama believes differentiates its platform from other RNA-based therapeutic approaches currently in development.
Atisama’s Chief Medical and Development Officer, Ed Tucker, stated that clinical progress remains on track, with safety and tolerability data supporting advancement into higher-dose MAD cohorts. The company believes these future cohorts may provide early insights into target engagement and biological activity, which could help shape future development decisions for RB042. Chronic inflammatory respiratory diseases remain a major unmet medical need globally, and Atisama aims to position RB042 as a novel therapeutic option capable of addressing underlying molecular imbalances rather than only controlling symptoms. The company’s SSO technology platform is also being leveraged across multiple additional inflammatory disease programs currently in preclinical development.
Bernard Coulie Appointed as Board Chair
Atisama also announced the appointment of Dr. Coulie as Chair of the Board at what company leadership described as a critical growth stage for the business. Dr. Coulie currently serves as President and CEO of Pliant Therapeutics and brings more than 25 years of international biopharmaceutical leadership experience across clinical development, corporate strategy, and pulmonary disease research. His previous executive leadership roles include senior positions at Johnson & Johnson and Actogenix, along with extensive governance experience through board appointments at multiple biotechnology companies. Atisama believes his expertise in pulmonary medicine aligns closely with the company’s lead clinical respiratory program and broader pipeline ambitions.
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Chief Executive and Scientific Officer Siro Perez stated that Dr. Coulie’s strategic leadership, governance experience, and global biotech network will play an important role as Atisama scales operations and advances toward later-stage clinical development. Dr. Coulie described Atisama’s scientific approach as highly differentiated and emphasized the strong biological rationale behind the company’s platform targeting respiratory inflammatory diseases. He also highlighted the company’s clinical progress to date and expressed confidence in supporting its future development plans. Atisama said the leadership appointment strengthens the company’s position as it continues advancing RB042 and expanding its pipeline of novel SSO-based inflammatory disease therapies.
Atisama Expands Focus on RNA-Based Inflammatory Therapies
Atisama Therapeutics is developing a pipeline of splice-switching oligonucleotide therapies designed to restore molecular balance in inflammatory diseases by modulating RNA splicing pathways. The company’s platform aims to simultaneously suppress harmful protein isoforms while increasing protective isoforms, potentially creating broader and more durable therapeutic effects. RB042, the company’s lead inhaled candidate, is currently the most advanced program and is being positioned for respiratory inflammatory indications where existing treatment options remain limited or associated with long-term safety concerns.
The company believes growing interest in RNA therapeutics and precision molecular medicine is creating significant opportunities for differentiated technologies such as SSOs. By combining targeted molecular regulation with inhaled delivery approaches, Atisama aims to improve treatment precision while potentially reducing systemic side effects often associated with conventional anti-inflammatory therapies. With RB042 now advancing into MAD cohorts and expanded leadership expertise at the board level, Atisama is positioning itself for broader clinical expansion and future growth within the global biotechnology sector.
Source: Atisama Therapeutics press release
