#Australia #Melbourne #RB042 #Atisama #Bernard Coulie

Atisama Therapeutics Progresses with RB042 in Phase 1 Trial

Atisama Therapeutics, formerly known as Rage Bio, has recently made significant strides in its clinical development of RB042, its leading candidate tailored for chronic inflammatory diseases. This Australian biotechnology company, which is at the forefront of innovation in splice-switching oligonucleotide (SSO) therapies, announced its advancement into multiple ascending dose cohorts in its Phase 1 clinical trial. Additionally, the appointment of Dr. Bernard Coulie as Chair of the Board marks a strategic move as the company prepares for further growth.

Phase 1 Clinical Updates

The Phase 1 trial of RB042, listed as RB042_1001 (NCT07285122), aims to evaluate the safety and tolerability of the drug through its initial dosing stages. The trial has successfully transitioned into multi-dose ascending cohorts after three of the four single ascending dose cohorts showcased positive outcomes regarding safety and tolerability. The new phase kicked off with the first cohort already in progress, and higher-dose cohorts are anticipated to yield results by the second half of 2026.

Dr. Ed Tucker, Chief Medical and Development Officer at Atisama, expressed optimism regarding the current developmental trajectory of RB042. He commented, “The clinical progress of RB042 is adhering to our established timeline. The positive outcomes from the initial dosing cohorts have facilitated our transition into the next phase of dosing. We expect that the higher-dose cohorts will provide early insights into how effectively the drug engages with its targets, aiding future developments—readouts are expected later this year.”

Leadership Transition with Bernard Coulie

Alongside these clinical updates, Atisama has welcomed Dr. Bernard Coulie as the new Chair of the Board of Directors. This appointment comes at a crucial time as the company gears up for significant expansion and shifts into a more advanced stage of clinical development. Dr. Coulie currently presides as the President and CEO of Pliant Therapeutics, specializing in integrin-based therapies, and brings over 25 years of extensive experience in the biopharmaceutical industry. His roles at Johnson & Johnson and various global biotech companies, coupled with his successful leadership in pulmonary disease sectors, align seamlessly with Atisama's mission.

In his own words, Dr. Coulie stated, “I am thrilled to be joining Atisama at such a pivotal moment. The work being done here is revolutionary in addressing unmet needs in respiratory medicine. The promising biological mechanisms at play, the robust team behind it, and the clinical updates thus far hold immense potential. I am eager to contribute to the company’s journey through the clinic and beyond.”

Dr. Siro Perez, Chief Executive and Scientific Officer, echoed this sentiment, emphasizing, “Bernard brings the strategic depth and governance expertise we require during this essential stage of growth. His notable record in pulmonary disease, experience in developing companies, and strong connections in the investment community make him a remarkable addition to our Board.”

Understanding RB042

RB042 is a unique inhaled splice-switching oligonucleotide devised to target the Receptor for Advanced Glycation End-products (RAGE), a validated contributor to the inflammatory processes seen in chronic obstructive pulmonary disease (COPD). This innovative therapy aims to reshape pre-mRNA expression, prioritizing the protective soluble isoform over the pro-inflammatory membrane-bound form. The implications of this approach are significant, as COPD currently impacts approximately 400 million people worldwide and remains one of the leading causes of mortality. Despite its prevalence, about 70% of COPD patients fall into non-eosinophilic categories, leaving them with few targeted therapeutic options—making RB042’s development increasingly vital.

Ongoing evaluations involve not just the primary indication of COPD but also potential expansions into various related diseases. The next set of results should provide more clarity about RB042's effectiveness across different clinical cohorts.

Conclusion

The advancements at Atisama reflect a critical moment in the biotech industry, demonstrating how persistent innovation can lead to potential breakthroughs in therapy. With the latest developments in the RB042 trial and the strategic leadership of Dr. Coulie, Atisama Therapeutics stands poised to make significant impacts on the respiratory health landscape. Stakeholders will be keenly watching the outcomes of the upcoming cohorts as the company continues its mission to address chronic inflammatory diseases through novel therapeutic strategies.

For further updates on Atisama Therapeutics and the RB042 clinical trial, visit www.atisama.com.