Atisama Therapeutics Advances RB042 into Multiple Ascending Dose cohorts of Phase 1 Trial and Appoints Bernard Coulie as Chair of the Board
Rhea-AI Summary
Atisama Therapeutics, an Australian clinical-stage biotech, reported that its lead candidate RB042 has progressed into multiple ascending dose (MAD) cohorts in an ongoing Phase 1 trial in healthy volunteers and healthy smokers, with safety and tolerability demonstrated to date.
The company also appointed Dr. Bernard Coulie, President and CEO of Pliant Therapeutics (NASDAQ: PLRX), as Chair of its Board of Directors, adding extensive pulmonary disease and governance experience as RB042 advances through early clinical development.
AI-generated analysis. Not financial advice.
Positive
- RB042 Phase 1 trial has advanced from single to multiple ascending dose cohorts
- Three of four single ascending dose cohorts completed with safety and tolerability supporting MAD dosing
- Higher-dose RB042 MAD cohorts expected to read out in H2 2026
- Appointment of Bernard Coulie as Board Chair adds 25+ years of biopharma leadership
- New Chair brings specific pulmonary disease expertise aligned with Atisama’s lead program
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves: SRZN -1.84%, ATOS -0.19%, HLVX -0.48%, while MGNX +15.24% and SAVA +8.68%, indicating stock-specific factors for PLRX rather than a uniform biotech move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 21 | Clinical data presentation | Positive | +0.8% | Bexotegrast clinical and preclinical data presented showing antifibrotic activity. |
| Mar 17 | Interim trial data | Positive | +10.4% | Promising interim Phase 1 data for PLN-101095 with notable tumor responses. |
| Mar 03 | Trial discontinued | Negative | -59.9% | BEACON-IPF Phase 2b discontinued following safety concerns despite early efficacy. |
| Feb 13 | DSMB review update | Negative | +21.0% | External panel convened after DSMB pause recommendation for BEACON-IPF trial. |
| Feb 07 | Trial pause | Negative | -60.6% | Voluntary pause in BEACON-IPF Phase 2b enrollment and dosing after DSMB review. |
Clinical trial headlines have produced volatile reactions, including large drawdowns around BEACON-IPF decisions, with an average move of -17.67% across past clinical updates.
Clinical-trial news for Pliant has centered on bexotegrast in pulmonary fibrosis and PLN-101095 in oncology. In Feb–Mar 2025, BEACON-IPF updates ranged from a voluntary pause to full discontinuation, driving large negative moves on some days and a sharp gain on one DSMB-related update. Other events, including promising PLN‑101095 Phase 1 data and bexotegrast presentations, saw more moderate positive reactions. Today’s Atisama-focused announcement intersects PLRX only through Bernard Coulie’s leadership role.
Historical Comparison
Over the past year, PLRX clinical-trial headlines averaged a -17.67% move, mixing sharp selloffs on BEACON-IPF setbacks with solid gains on positive PLN‑101095 data. Today’s article is indirectly related, highlighting Coulie’s external role alongside Atisama’s early RB042 progress.
Clinical news has tracked BEACON-IPF from DSMB-driven pause to full discontinuation, while PLN‑101095 advanced with encouraging Phase 1 results and broader data presentations.
Regulatory & Risk Context
An effective S-3 shelf filed on 2026-03-30 allows Pliant to offer up to $300,000,000 in various securities, including an at-the-market program for up to $50,000,000 of common stock, providing flexibility to raise capital for R&D and clinical programs.
Market Pulse Summary
This announcement centers on Atisama’s RB042 Phase 1 advancement and Bernard Coulie’s appointment as Chair, underscoring his more than 25 years of biopharma leadership and pulmonary expertise. For PLRX, it reinforces his industry stature while the company continues its own oncology and fibrosis programs. Historically, PLRX clinical news has triggered sizable stock moves, so investors may watch future trial updates, capital raises under the $300,000,000 shelf, and leadership developments across Coulie’s roles.
Key Terms
splice-switching oligonucleotide medical
phase 1 trial medical
single ascending dose medical
multiple ascending dose medical
healthy volunteers medical
integrin-based therapies medical
AI-generated analysis. Not financial advice.
- RB042 Phase 1 trial advances into multiple ascending dose study cohorts, demonstrating safety and tolerability to date.
- Dr. Coulie brings more than 25 years of international biopharma leadership and deep expertise in pulmonary disease to the Atisama Board of Directors.
RB042 Phase 1 Clinical Update
The RB042 Phase 1 study (RB042_1001; NCT07285122), evaluating RB042 in healthy volunteers and healthy smokers, has advanced to multi-dose ascending (MAD) cohorts, and continues to demonstrate safety and tolerability. Three of four single ascending dose (SAD) cohorts are complete, and the first MAD cohort has been initiated, with higher-dose cohorts expected to readout in H2 2026.
"RB042 clinical progress is tracking to plan. Safety and tolerability across three SAD cohorts have supported advancement into MAD dosing. Higher-dose cohorts may provide early insights into target engagement to inform future development, with readouts expected later this year," said Dr. Ed Tucker, Chief Medical and Development Officer.
Appointment of Bernard Coulie as Chair of the Board
Dr. Coulie joins Atisama at a pivotal moment, as RB042 advances through early clinical development and the Company prepares for its next phase of growth.
Dr. Coulie currently serves as President and CEO of Pliant Therapeutics (NASDAQ: PLRX), a clinical-stage biopharmaceutical company focused on the development of integrin-based therapies, and holds board positions at several global biotech companies. His career includes senior executive roles at Johnson & Johnson and Actogenix. He has founded and led companies across a range of therapeutic areas, with particular expertise in pulmonary disease, directly relevant to Atisama's lead clinical programme.
As Chair, Dr. Coulie brings deep governance experience and operational leadership to the Atisama Board, with clinical, scientific and commercial acumen that aligns directly with the Company's mission.
"Bernard brings exactly the strategic depth and governance experience we need as we scale and advance our pipeline toward later-stage clinical development. His track record in pulmonary disease, his experience building companies, and his strong relationships across the global investment community make him an exceptional addition to our Board. We are delighted to welcome him," said Dr. Siro Perez, Chief Executive and Scientific Officer.
"Atisama is working on a genuinely differentiated scientific approach to one of the most important unmet needs in respiratory medicine. The biology is compelling, the team is strong, and the clinical progress to date is highly encouraging. I am excited to join the Board and to support the Company as it moves through the clinic and into its next chapter," said Dr. Bernard Coulie, Chair of the Board.
About Atisama Therapeutics
Atisama Therapeutics Pty Ltd (ACN 640 194 770, formerly Rage Bio Pty Ltd) is a clinical-stage biotechnology company developing novel splice-switching oligonucleotide (SSO) therapies for inflammatory disease. Founded on the principle of restoring molecular balance for lasting health, the Company's SSO platform is producing drug candidates that down-regulate disease-driving isoforms and upregulates their protective counterparts; a dual-action mechanism unique to the SSO modality. Atisama's lead asset, RB042, is an inhaled SSO currently in Phase 1 clinical development. Atisama has several other programmes leveraging the novel SSO platform. The Company is headquartered in
About RB042
RB042 is an inhaled splice-switching oligonucleotide (SSO) targeting the Receptor for Advanced Glycation End-products (RAGE), a genetically validated driver of inflammation in chronic obstructive pulmonary disease (COPD). RB042 redirects pre-mRNA expression to the protective soluble esRAGE isoform over pro-inflammatory membrane-bound mRAGE, potentially shifting the isoform balance disrupted in disease. RB042 is currently being evaluated in a Phase 1 study (RB042_1001; NCT07285122) in healthy volunteers and healthy smokers across single ascending dose and multiple ascending dose cohorts. COPD affects approximately 400 million people globally and is the third leading cause of death; approximately
For more information, visit www.atisama.com or contact media@atisama.com.
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SOURCE Atisama Therapeutics