A Phase-2 Study to Evaluate the Ability of HT-6184 to Attenuate Diagnostic Biomarkers of Post-procedure Acute Inflammation and Manage Pain Following Third Molar Extraction

The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.
The main question it aims to answer are:
* Does HT-6184 decrease inflammation in patients after third molar removal?
* Does HT-6184 decrease pain in patients after third molar removal?
Participants will be asked to do the following during the clinical trial:
* Take a single oral dose of HT-6184 or placebo
* Allow a oral surgeon remove their third molar teeth
* Blood draws on 5 occurrences
* Rate their pain intensity
* Attend two follow-up appointments on day 1 and day 2 after third molar removal
* Participate in one follow-up phone call 5-7 days after third molar removal

Start Date12 Feb 2024

Sponsor / Collaborator

Halia Therapeutics, Inc.Startup

CTRI/2023/11/059758 / Not yet recruitingPhase 2

A Phase 2a study of HT-6184 in subjects with IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia. - NIL

Start Date24 Nov 2023

Sponsor / Collaborator

Halia Therapeutics, Inc.Startup

NCT05447546 / CompletedPhase 1

A Phase 1, Single-Center, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-6184 in Healthy Human Subjects

The primary objectives of this study are to evaluate the safety and tolerability of HT-6184 when administered as single oral doses at escalating dose levels in healthy volunteer subjects.
The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-6184. Results of the PD analyses will be used to determine the minimal biologically effective dose (MBED): the lowest dose that achieves >70% target inhibition compared to unstimulated vehicle controls over 24 hours in 4 of 6 treated volunteers.

Start Date15 Jun 2022

Sponsor / Collaborator

Halia Therapeutics, Inc.Startup

[+1]

100 Clinical Results associated with Ofirnoflast

100 Translational Medicine associated with Ofirnoflast

100 Patents (Medical) associated with Ofirnoflast

News (Medical) associated with Ofirnoflast

21 Oct 2024

·www.prnewswire.com

Halia Therapeutics to Attend Global Health Exhibition 2024

Halia Therapeutics will showcase its LRRK2 and NEK7 inhibitors targeting Alzheimer's disease and obesity. LEHI, Utah, Oct. 21, 2024 /PRNewswire/ -- Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company pioneering innovative treatments for inflammatory and neurodegenerative diseases, today announced that it will showcase its scientific data and progressive pipeline at the upcoming Global Health Exhibition. The event will occur October 21–23, 2024, in Riyadh, Saudi Arabia. Halia Therapeutics will host an exhibition booth to showcase its efforts in targeting two indications, Alzheimer's disease and obesity. Halia's candidate HT-4253 is a LRRK2 inhibitor administered orally with excellent brain penetration. LRRK2 is a key modulator of neuroinflammation, which plays a critical role in neurodegenerative diseases. HT-6184 is a first-in-class, selective and orally bioavailable inhibitor of the NEK7/NLRP3 inflammasome. HT-6184 is being tested in combination with semaglutide to target inflammation, which has been linked to obesity-related metabolic dysfunction. Halia's drug candidates are designed to provide novel approaches to improve patients' lives affected by neurodegenerative diseases and chronic inflammatory disorders. Global Health Exhibition unites visionaries, policymakers, government agencies, healthcare luminaries, scientists and futurists to forge a healthier, more innovative future. Visit Halia at booth H1C-W83 in the USA Pavillion. To view the full agenda please visit About NLRP3 NLRP3, an innate immune sensor, is activated in response to various pathogenic and sterile stimuli. Activation of NLRP3 triggers the release of the pro-inflammatory cytokines IL-1β and IL-18 and induces a lytic cell death process called pyroptosis. These mechanisms lead to systemic chronic inflammation. Halia's therapeutic inhibits NLRP3, preventing the formation of the NLRP3 inflammasome and promoting its disassembly once formed. This inhibition blocks the production and release of IL-1β and IL-18. Chronic NLRP3 inflammasome activation is believed to drive the onset and progression of many conditions, including fibrotic, dermatological, and auto-inflammatory diseases. Moreover, it plays a significant role in neurodegenerative and neuroinflammatory disorders such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis. About HT-6184 HT-6184 is a groundbreaking drug candidate that targets the protein NEK7 through an allosteric mechanism. NEK7 plays a crucial role in the NLRP3 inflammasome, which is essential for its assembly and activity maintenance. In preclinical models, Halia demonstrated that inhibiting the NEK7's ability to bind to NLRP3 disrupts inflammasome signaling and reduces the inflammatory response. HT-6184 not only prevents the formation of the NLRP3 inflammasome but also promotes its disassembly once activated. (Halia unpublished data). About HT-4253 HT-4253 is an orally administered small molecule with excellent brain penetration that targets LRRK2, a key mediator of neuroinflammation. Chronic brain inflammation is a driver of several neurodegenerative diseases, including Parkinson's and Alzheimer's. Halia scientists have demonstrated that LRRK2's essential role in regulating neuroinflammation. LRRK2 inhibition by HT-4253 offers a novel approach to treat neurodegenerative diseases with an inflammation component, potentially altering disease progression. HT-4253 is undergoing a Phase I trial to evaluate the safety and tolerability in healthy volunteers (NCT06537817). About Halia Therapeutics, Inc. Halia Therapeutics is pioneering novel therapeutics to enhance patients' lives with chronic inflammatory disorders and neurodegenerative diseases. Halia's initial programs target NEK7 and LRRK2.Headquartered in Lehi, Utah, Halia Therapeutics invites you to learn more about our work. Visit our website at , connect with us on LinkedIn, and follow our updates on Twitter (X). Company Contact Halia Therapeutics [email protected] +1 (385) 355-4315 Media Contact: Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC +1 (646) 942-5604 [email protected] SOURCE Halia Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1

14 Oct 2024

·www.prnewswire.com

Halia Therapeutics to Participate in Panel at BIO Investor Forum 2024

Dr. David J. Bearss, CEO, will partake in a panel focused on Neurodegenerative Disease Targets and Pipelines on Tuesday, October 15 at 11:00-11:50 am PT LEHI, Utah, Oct. 14, 2024 /PRNewswire/ -- Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for inflammatory and neurodegenerative diseases, today announced that David J. Bearss, Ph.D., President and CEO of Halia Therapeutics, will participate in a panel at the BIO Investor Forum taking place October 15-16, 2024, in San Francisco, CA. Dr. Bearss will take part in the panel discussion: 'Expansion of Neurodegenerative Disease Targets and Pipelines' which will take place on Tuesday, October 15, 11:00-11:50 am PT at the Venetian Room, Fairmont San Francisco. This session will feature leading innovators who will discuss the latest advancements in diverse approaches to neurodegenerative diseases. Attendees will learn about the evolving landscape of neurodegenerative disease research and development, the potential of novel targets, and the implications for future treatment and investment opportunities. A Phase 1 trial evaluating Halia Therapeutics' compound HT-4253 was recently initiated to assess its safety, tolerability, and pharmacokinetics in healthy adults. HT4253 functions by inhibiting LRRK2, a regulator in neuroinflammation associated with Alzheimer's and Parkinson's disease. Bio Investor Forum showcases drug development programs that are ready for partnering and venture funding, with a focus on treating patients by accelerating the progress of new therapeutic technologies into commercialization. David J. Bearss, Ph.D., President and CEO, will be available for one-on-one investor meetings with registered conference attendees at the forum. Meetings can be scheduled through the partnering system. To view the full agenda please visit . About HT-4253 HT-4253 is an orally administered small molecule with excellent brain penetration that targets a mediator of neuroinflammation called LRRK2. Chronic inflammation in the brain is a driver of several neurodegenerative diseases, such as Parkinson's disease and Alzheimer's disease. Halia scientists have shown that LRRK2 is an essential regulator of neuroinflammation. LRRK2 inhibition by HT-4253 could represent a new way to treat neurodegenerative diseases with an inflammation component by changing how the disease progresses. HT-4253 is currently being evaluated in a Phase I trial determining its safety and tolerability in healthy volunteer subjects (NCT06537817). About Halia Therapeutics, Inc. Halia Therapeutics is discovering and developing a pipeline of novel therapeutics to improve patients' lives with chronic inflammatory disorders and neurodegenerative diseases, with its initial programs targeting NEK7 and LRRK2. Halia's lead candidate, HT-6184, a novel NEK7/NLRP3 inhibitor, has completed a Phase I study (NCT05447546) evaluating the safety and tolerability of HT-6184 when administered as single or multiple oral doses at escalating dose levels in healthy volunteer subjects. Halia has also initiated 2 Phase II trials to evaluate the efficacy of HT-6184 for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) and on post-procedure diagnostic biomarkers of inflammation and pain (NCT06241742). Halia recently initiated a Phase I trial evaluating the safety and tolerability of its LRRK2 inhibitor, HT-4253, in healthy volunteer subjects (NCT06537817). The company's headquarters are in Lehi, Utah. For more information, visit or follow us on LinkedIn and Twitter (X). Company Contact Halia Therapeutics [email protected] +1 (385) 355-4315 Media Contact: Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC +1 (646) 942-5604 [email protected] SOURCE Halia Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 2

08 Oct 2024

·pipelinereview.com

Halia Therapeutics Announces First Healthy Volunteer Dosed with HT-4253, a Novel Oral LRRK2 Inhibitor Targeting Neuroinflammation in Alzheimer's Disease

LEHI, Utah I October 7, 2024 I Halia Therapeutics, a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for inflammatory and neurodegenerative diseases, today announced that the first healthy volunteer was dosed in its Phase 1 clinical trial evaluating its LRRK2 inhibitor, HT-4253, for a potential treatment for Alzheimer’s Disease. “Dosing the first subject in the Phase 1 trial of HT-4253 marks a significant step in the fight against neurodegenerative diseases such as Alzheimer’s disease,” said Dr. David Bearss , CEO of Halia Therapeutics. “We believe that HT-4253 will provide a groundbreaking treatment option for patients who currently have few choices to prevent or delay Alzheimer’s onset, as the drug targets the underlying neuroinflammation linked to causing neurocognitive disease.” The Phase 1 clinical trial ( ClinicalTrials.gov ID: NCT06537817 ) is a first-in-human, randomized, placebo-controlled, double-blind study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HT-4253. This study will employ a single ascending dose (SAD) and multiple ascending dose (MAD) format, designed to explore the potential of HT-4253 to inhibit LRRK2—a critical enzyme designed to explore the potential of HT-4253 to inhibit LRRK2. Recent human genetic studies have revealed specific variants of the Rab10 gene protect individuals with the APOE4 genotype—a known risk factor for Alzheimer’s disease. These variants inhibit Rab10, a key protein activated by LRRK2, thus reducing neuroinflammation and offering neuroprotection. Halia’s LRRK2 inhibitor, HT-4253, mimics these Rab10 variants by blocking LRRK2, which in turn prevents Rab10 activation. This mechanism shows promise for preventing or delaying Alzheimer’s onset in APOE4 carriers by replicating the protective effects observed in resilient individuals. About HT-4253 HT-4253 is an orally administered small molecule tablet with excellent brain penetration. It targets LRRK2, a key mediator of neuroinflammation. Chronic brain inflammation drives several neurodegenerative diseases, including Parkinson’s and Alzheimer’s. Halia scientists have demonstrated that LRRK2 is crucial in regulating neuroinflammation. By inhibiting LRRK2, HT-4253 could offer a novel approach to treating neurodegenerative diseases with an inflammatory component, potentially altering disease progression. About Halia Therapeutics, Inc. Halia Therapeutics is pioneering novel therapeutics to enhance patients’ lives affected by chronic inflammatory disorders and neurodegenerative diseases. Our initial programs focus on NEK7 and LRRK2 targets. Our lead candidate, HT-6184—a novel NEK7/NLRP3 inhibitor—has successfully completed a Phase I study ( NCT05447546 ). This study evaluated HT-6184’s safety and tolerability when administered as single or multiple oral doses at escalating levels in healthy volunteers. Additionally, we’ve completed a Phase II trial assessing HT-6184’s efficacy on post-procedure diagnostic biomarkers of inflammation and pain ( NCT06241742 ). Currently, we’re conducting a Phase II trial to investigate HT-6184’s efficacy in treating lower-risk myelodysplastic syndromes (LR-MDS). Headquartered in Lehi, Utah, Halia Therapeutics is at the forefront of innovative drug development. For more information, visit www.haliatx.com or follow us on LinkedIn and Twitter (X) . SOURCE: Halia Therapeutics

Phase 1Phase 2

100 Deals associated with Ofirnoflast

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 2	US	Halia Therapeutics, Inc.Startup	12 Feb 2024
Pain, Postoperative	Phase 2	US	Halia Therapeutics, Inc.Startup	12 Feb 2024
Post procedural inflammation	Phase 2	US	Halia Therapeutics, Inc.Startup	12 Feb 2024
Myelodysplastic Syndromes	Phase 2	-	Halia Therapeutics, Inc.Startup	13 Dec 2023
Eye Diseases	Preclinical	US	Halia Therapeutics, Inc.Startup	11 Oct 2024

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