Upon the announcement of favorable topline study data, Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) experienced a notable upward trend in its share price this morning. At the latest check during the current trading session, XERS stock had risen by 15.84%, reaching $2.24.
Promising Phase 2 Study Results
Xeris Biopharma (XERS) disclosed topline outcomes from its recently concluded Phase 2 multi-center, open-label study of XP-8121, aimed at treating adults with hypothyroidism. The XP-8121 formulation leverages the company’s XeriSol technology, facilitating a novel once-weekly subcutaneous injection of levothyroxine.
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Study Design And Clinical Implications
The Phase 2 study was a non-randomized, open-label, single-arm, self-controlled investigation of XP-8121 (levothyroxine sodium). It aimed to establish a target dose conversion factor from stable oral levothyroxine to XP-8121 in 46 patients with hypothyroidism, while also evaluating the safety and tolerability of XP-8121 following once-weekly subcutaneous injections.
The study capitalized on bioavailability data from a preceding Phase 1 study, which demonstrated that participants could achieve comparable systemic exposure with XP-8121 at just 57% of the weekly oral dose.
Addressing Hypothyroidism Prevalence And Treatment Challenges
According to a 2022 research that was published in the Journal of the Endocrine Society, around 30 million individuals in the US were projected to have hypothyroidism as of 2019 with a prevalence of 11.7%. The bioavailability of oral levothyroxine can be impacted by a number of compliance and absorption problems that have been noted in several papers.
In Xeris Biopharma’s Phase 2 study, 40% of patients deemed stable at the time of screening had TSH or T4 levels outside the normal range. The once-weekly subcutaneous injection is believed to offer better control for patients facing difficulties with oral preparations for diverse reasons.
Future Steps And Regulatory Engagement
The preliminary top-line results from the Phase 2 dose-finding study of XP-8121 align with the target dose conversion estimates from the prior Phase 1 study involving healthy volunteers. With the difficulties in levothyroxine’s oral bioavailability and the high percentage of screen failures seen in the Phase 2 study, XP-8121 may be able to fill a sizable medical need.
Xeris Biopharma expects to share the full research data at future medical conferences and submit them to peer-reviewed medical publications. The company also aims to meet with the FDA later this year.
