DE MONITOR - Dé Pharming Expert schreef op 28 september 2021 09:05:
Catabasis heeft de naam veranderd, alles in voorbereiding naar de launch van de HAE trial.
Catabasis, Now Renamed Astria, Working Toward HAE Trial LaunchCatabasis now renamed Astria Therapeutics | Angioedema News | thumbs up all-around illustration
Astria Therapeutics is the new name of the company that’s developing STAR-0215, an investigational kallikrein-inhibitor previously known as QLS-215, for the treatment of hereditary angioedema (HAE).
Formerly called Catabasis Pharmaceuticals, the company said it changed its name to reflect its pledge of having patients serve as its guiding stars. According to the company, Astria “originates from the Greek word for star.”
Earlier this year, STAR-0215 became Astria’s lead product following the acquisition of Quellis Biosciences, the therapy’s original developer. Astria now expects to file an application in mid-2022 to launch a Phase 1 proof-of-concept trial of STAR-0215, with results anticipated by the end of next year.
“The name Astria embodies our commitment to put patients first in all that we do,” Jill Milne, PhD, CEO of Astria, said in a press release. “Following the acquisition of Quellis earlier this year, our company is focused on tackling the debilitating disease hereditary angioedema, with the broader goal of addressing the unmet needs of patients with rare and niche allergic and immunological diseases.”
STAR-0215 is an antibody-based medicine designed to prevent HAE attacks by suppressing the activity of kallikrein. This enzyme is overly active in HAE patients due to the lack of another protein, called C1-inhibitor, that normally controls its activity. Excess kallikrein activity increases the levels of an inflammatory molecule, called bradykinin, which causes blood vessels to expand and tissues to swell.
The therapy has a similar mechanism of action to the approved HAE therapy Takhzyro (lanadelumab), but preclinical studies have shown that it is more potent and has greater stability in the bloodstream.
According to the company, STAR-0215 has many potential benefits, such as allowing for smaller injection volumes, requiring less frequent dosing, and enabling patients to remain free of breakthrough attacks for extended periods of time.
Preclinical studies demonstrated STAR-0215 binding to kallikrein is about 10 times stronger than that of Takhzyro. The experimental therapy also was about 10 times more potent than Takhzyro at suppressing the enzyme’s activity by 90% — the optimal level estimated to reduce HAE attacks and maximize the time without attacks.
Studies in non-human primates also have shown that STAR-0215’s mean half-life in the bloodstream was much longer than that of Takhzyro (33.6 vs. 10.5 days). Of note, half-life is the time it takes for the levels of a specific compound to drop to half of what was originally administered.
Based on these findings, STAR-0215 is predicted to remain above the minimum therapeutic levels for more than 84 days, while Takhzyro’s levels are expected to fall below this therapeutic threshold after approximately 10 days. This in turn translates to a more prolonged suppression of kallikrein enzyme activity.
The Phase 1 proof-of-concept trial aims to evaluate the safety and pharmacological properties of a single ascending dose, as well as multiple doses, of STAR-0215 in a group of healthy volunteers.
The study’s primary goals will be to evaluate the therapy’s safety and tolerability, along with its half-life and ability to inhibit kallikrein in the bloodstream. These data will then be used to refine the dose and dosing regimen for future efficacy studies in HAE patients.
“We are advancing STAR-0215 as a differentiated and potentially the most patient-friendly preventative treatment option with dosing once every three months or longer,” Milne said. “We are proud to launch Astria Therapeutics and bring our team’s combination of experience, passion, and compassion to our future vision and our commitment to patients and their families.”