#USA #Halia Therapeutics #Lehi #HT-6184 #Myelodysplastic Syndrome

Halia Therapeutics Completes Enrollment in Phase 2a Clinical Trial of HT-6184

Halia Therapeutics, a pioneering name in the biopharmaceutical arena, has officially concluded the patient enrollment for its open-label Phase 2a clinical trial targeting HT-6184, known as Ofirnoflast, in individuals diagnosed with lower-risk Myelodysplastic Syndrome (MDS). This condition primarily affects the bone marrow and blood cell production, leading to a range of health complications.

The clinical study is specially designed to assess the effectiveness, safety, and biomarker responsiveness of HT-6184. As an innovative allosteric modulator of NEK7, it aims to disrupt the protein interactions that contribute to the formation of the NLRP3 inflammasome, a crucial factor associated with inflammation in MDS. The trial has successfully enrolled a total of 33 patients, including 18 in Stage 1 and an additional 15 in Stage 2, marking a significant milestone for the company.

“The completion of this enrollment signifies a critical step in demonstrating our unique approach to target innate immune dysfunction,” stated Dr. David Bearss, the CEO of Halia Therapeutics. “This study holds the potential to provide essential proof-of-concept data, indicating the ability of HT-6184 to mitigate clonal inflammation while enhancing hematologic outcomes for patients facing symptomatic anemia.”

The trial outlines a 16-week treatment segment, after which participants who respond positively will have the opportunity to continue treatment. For non-responders, there exists a possibility of extending treatment for up to 16 weeks, either as a standalone therapy or in conjunction with previously administered erythropoiesis-stimulating agents (ESA). Key goals of the study encompass evaluating treatment efficacy through improvements in hematological measures, reduced clonal prevalence, and variant allele frequency (VAF) decline. Furthermore, aspects of patient safety and overall quality of life will be monitored rigorously throughout the trial.

Interim analyses of Stage 1 have already been conducted, and the team anticipates unveiling the topline results of the entire study later this year, representing a pivotal moment for all stakeholders involved, particularly the patients.

About Halia Therapeutics

Founded with a vision to redefine treatment paradigms, Halia Therapeutics focuses on harnessing genetic resilience to target the innate immune system. The foundational research spearheaded by the organization has revealed protective mutations within individuals who possess a genetic predisposition to severe diseases. By delving deep into this genetic framework, Halia aims to restore immune equilibrium for a spectrum of inflammatory and neurodegenerative conditions.

In addition to HT-6184, Halia's pipeline includes:

• - HT-6184: Currently in Phase 2a for Myelodysplastic Syndrome.
• - HT-6184 with Semaglutide: A planned clinical trial aiming to address obesity and Type 2 diabetes, set to launch in Q3 2025.
• - HT-4253: A drug targeting neuroinflammation, currently being evaluated in an ongoing Phase 1 trial, also expected to conclude in Q3 2025.

For more in-depth information about HT-6184, HT-4253, or ongoing clinical studies, please visit Halia Therapeutics.