Halia Therapeutics is planning to start two Phase II trials evaluating its lead drug HT-6184 before the end of the year, said CEO David Bearss in an interview with Pharmaceutical Technology.
According to Bearss, the US-headquartered biotech aims to initiate a Phase IIa trial of the compound in low-risk myelodysplastic syndrome by the end of Q3 2023.
He explained that Halia has been interested in targeting inflammation in bone marrow disorders, which is why the company will focus on low-risk myelodysplastic syndrome.
The trial will likely first open in India, before launching in the US in Q4 2023, he added. Bearss stated that this is because the regulatory authorities overseeing the trial’s Asia-based sites have been ahead of those in the US. He added that the company will then likely add European sites next year in nations such as France, Germany, and the UK.
HT-6184 targets the protein NEK7 by blocking its ability to bind to NLRP3, which reduces the inflammatory response, per the company’s website. The activation of NLRP3 drives the onset and progression of various conditions, including neurological and rheumatological diseases.
According to Bearss, Halia also wants to run a second Phase II trial that will test HT-6184's ability to address the inflammatory response to wisdom tooth extraction. The company will start the trial in Q4 2023, with a planned topline readout in Q1 2024. In addition, the trial will compare HT-6184 against a placebo and take place at a single site in the US.
On 7 August, Halia announced the completion of enrollment in a Phase I trial (NCT05447546) of HT-6184 and plans to release data from the study in Q4 2023, according to the announcement.
Looking at next year, Halia is setting its sights on testing further compounds in the clinic. The biotech plans to start a Phase I trial of HT-4253, an LRRK2 inhibitor, which will predominantly focus on the compound’s safety. However, the study will also feature select pharmacodynamic and pharmacokinetic endpoints.
Bearss added that the company plans to recruit between 60 to 80 participants in the study. While a part of this group will consist of healthy volunteers, the biotech is considering including patients with Alzheimer’s disease.
To power these efforts, Halia remains on track to close a Series C fundraising round this year, said Bearss. In February 2023, the website Biospace reported that this would be a $50m Series C round. The CEO stated that this sum remains the target.
On 16 August, the company announced the opening of its new headquarters in Lehi, Utah.
