Categories: Health

Halia Therapeutics Completes Enrollment in Phase 2a Clinical Trial of HT-6184 for Myelodysplastic Syndrome (MDS)

LEHI, Utah, June 4, 2025 /PRNewswire/ — Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering therapies inspired by genetic resilience, today announced the completion of enrollment for its open-label Phase 2a clinical trial evaluating HT-6184 (Ofirnoflast) in patients with lower-risk Myelodysplastic Syndrome (MDS) who are refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents (ESA).

- Advertisement -

The study (CTRI/2023/11/059758) is designed to evaluate the efficacy, safety, and biomarker response of HT-6184, a novel allosteric modulator of NEK7 that disrupts NEK7–NLRP3 protein interaction, thereby preventing the formation of the NLRP3 inflammasome. This mechanism also promotes the disassembly of pre-formed NLRP3 inflammasomes, targeting a key inflammatory pathway implicated in bone marrow dysfunction in myelodysplastic syndromes (MDS). The two-stage study enrolled 18 evaluable patients in Stage 1 and has now completed enrollment of an additional 15 participants in Stage 2.

- Advertisement -

“Completing enrollment in our Phase 2a MDS study is a major milestone as we continue to validate our mechanism of action targeting innate immune dysregulation,” said Dr. David Bearss, CEO of Halia Therapeutics. “This study provides important proof-of-concept data to support the therapeutic potential of HT-6184 in reducing clonal inflammation and improving hematologic outcomes for patients with symptomatic anemia.”

The trial consists of a 16-week treatment period, followed by a response-based continuation phase. Responders may continue on therapy, while non-responders showing a greater than 30% reduction in variant allele frequency (VAF) clone size may receive up to 16 additional weeks of treatment, either as monotherapy or in combination with prior ESA therapy. Key study objectives include evaluating efficacy through hematological improvement, clonal suppression, and VAF reduction, assessing safety and patient tolerance, monitoring changes in inflammasome-related biomarkers, and measuring quality of life using patient-reported outcome tools.

- Advertisement -

An interim analysis was conducted following Stage 1, and topline results from the complete study are expected later this year.

- Advertisement -

About Halia Therapeutics
Halia Therapeutics is redefining treatment paradigms by targeting the innate immune system and harnessing genetic resilience. Founded on breakthrough research identifying protective mutations in individuals genetically predisposed to severe diseases, Halia’s therapies aim to restore immune balance in inflammatory and neurodegenerative conditions.

The company’s pipeline includes:

- Advertisement -
  • HT-6184, currently in a Phase 2a trial for Myelodysplastic Syndrome (MDS)
  • HT-6184, in combination with semaglutide, a planned Phase 2a trial in obese and Type 2 diabetes (T2D) patients, is expected to initiate in 3Q25.
  • HT-4253, a neuroinflammation-targeted candidate, is currently in an ongoing Phase 1 clinical trial (NCT06537817), expected to conclude in 3Q25.

For more information about Ofirnoflast (HT-6184), HT-4253, or ongoing clinical trials, please visit www.haliatx.com.

- Advertisement -

Media Contact

Taylor Avei
Director of Business Development
Halia Therapeutics
info@haliatx.com 

- Advertisement -

Photo – https://mma.prnewswire.com/media/2702932/Halia_Therapeutics_Logo.jpg

- Advertisement -

View original content:https://www.prnewswire.co.uk/news-releases/halia-therapeutics-completes-enrollment-in-phase-2a-clinical-trial-of-ht-6184-for-myelodysplastic-syndrome-mds-302472862.html

PRNW Agency

Recent Posts

Colgate’s Bright Smiles, Bright Futures Program Celebrates Reaching Over Two Billion Children and Their Families Around the World

Over 185 million children and their families engaged pan India with significant partnerships with state…

33 minutes ago

CLO Launches Marvelous Designer for Linux, Expanding Support for Professional Pipelines

NEW YORK, Sept. 25, 2025 /PRNewswire/ -- CLO Virtual Fashion, a global leader in digital…

33 minutes ago

STL deepens partnership with Netomnia to accelerate the UK’s future-ready full-fibre rollout

- End-to-end FTTH solutions from advanced optical fibre cables to high-performance connectivity to speed rollout…

3 hours ago

SUNMI Named Google Android Enterprise Gold Partner and Earns AER Certification, Setting a Global Benchmark for Smart Commercial Devices

SINGAPORE, Sept. 26, 2025 /PRNewswire/ -- SUNMI, a global leader in smart commercial devices, announced…

3 hours ago

Logistics at Scale: India’s 3PL Market Rewrites the Leaderboard on the Road to a Billion Parcels – Says Redseer

BENGALURU, India, Sept. 26, 2025 /PRNewswire/ -- India's logistics industry is experiencing a significant shake-up.…

3 hours ago

Building Retail Resilience in New Delhi: Coca-Cola India’s Commitment to Local Entrepreneurs

NEW DELHI, Sept. 26, 2025 /PRNewswire/ -- Kirana stores are the backbone of India's consumer ecosystem.…

3 hours ago