#USA #Orlando #Halia Therapeutics #Ofirnoflast #NEK7 Inhibitor

Halia Therapeutics to Present Ofirnoflast at ASH 2025

Halia Therapeutics, an innovative biopharmaceutical firm dedicated to developing groundbreaking therapies, has announced its participation in the 67th American Society of Hematology (ASH) Annual Meeting, scheduled for December 6-9, 2025, in Orlando, Florida. A prominent highlight of their presentations will be the allosteric NEK7 inhibitor, Ofirnoflast, which exhibits considerable promise in treating myelodysplastic syndrome (MDS) and various inflammatory conditions.

Innovative Mechanism of Action

Ofirnoflast operates through a unique mechanism by targeting NEK7, a crucial component necessary for the assembly of the NLRP3 inflammasome, which plays a significant role in the inflammatory processes leading to anemia and disease progression. By inhibiting this inflammasome, Ofirnoflast interrupts inflammatory cascades without exerting broad immunosuppressive effects common in other treatments.

The data will showcase how Ofirnoflast leads to robust and sustained hematologic responses, offering hope to patients battling MDS, a condition characterized by ineffective hematopoiesis and a predisposition to acute myeloid leukemia.

Clinical and Preclinical Data

In the current clinical trials, researchers have observed remarkable results demonstrating Ofirnoflast's efficacy in managing hematologic responses in patients classified under IPSS-R very low, low, or intermediate risk categories—and symptomatic anemia associated with MDS.

Along with the promising clinical data, the findings presented at ASH will include preclinical studies supporting the utility of Ofirnoflast in addressing hemolytic anemias by effectively quelling heme-induced inflammation. This suggests a broader application beyond MDS, potentially extending to patients with obesity-induced inflammatory anemia.

Presentation Schedule at ASH 2025

Halia will present six poster presentations alongside one oral presentation outlining important clinical findings:
1. Ofirnoflast, a Novel Inflammasome Inhibitor, explores the drug’s ability to recalibrate transcriptional programs while demonstrating clinical and preclinical efficacy across various myeloid neoplasms.
2. Suppression of Heme-induced Inflammation highlights Ofirnoflast’s role as a therapeutic strategy for managing inflammatory responses in hemolytic anemias.
3. Combination Strategies focusing on Ofirnoflast and Semaglutide, illuminating results in mitigating inflammation during obesity-induced anemia in preclinical rodent models.
4. Several presentations will elaborate on Ofirnoflast's efficacy, examining its inhibition of pro-inflammatory cytokines and its impact on oxidized mitochondrial DNA levels in patients with MDS.

Halia Therapeutics — A Commitment to Innovation

Halia Therapeutics is leading the charge in precision medicine, centering its development around the needs of patients facing severe inflammatory diseases. The unique approach of Ofirnoflast, alongside its differentiated mechanism of action targeting the NEK7-NLRP3 inflammasome pathway, signifies a transformative therapy—promising significant advancements for patients with limited treatment options.

As David Bearss, CEO of Halia Therapeutics, stated, "The data we are sharing at ASH 2025 signifies a crucial milestone, not just for us but for patients who continue to struggle with MDS and related conditions. We believe that Ofirnoflast can represent a new era in addressing inflammatory pathways that exacerbate these diseases."

With its focus on addressing critical medical needs through innovative mechanisms, Halia Therapeutics remains steadfast in its mission to deliver groundbreaking solutions for those suffering from serious inflammatory and hematologic conditions.

Conclusion

The unveiling of Ofirnoflast at the ASH 2025 Annual Meeting establishes Halia Therapeutics as a leading innovator in the biopharmaceutical landscape. With robust findings from both clinical and preclinical studies, the company is set to reshape therapeutic strategies for hematologic conditions, offering renewed hope to countless patients awaiting better treatment options.