CHICAGO - Xeris Biopharma Holdings, Inc. (NASDAQ: XERS), a biopharmaceutical company, has announced the successful completion of a Phase 2 study for its investigational drug XP-8121, using the company's proprietary XeriSol™ technology for treating hypothyroidism. The study results suggest that XP-8121, a once-weekly subcutaneous injection of levothyroxine, could offer a more consistent thyroid hormone level with reduced drug usage compared to daily oral treatments.
The non-randomized, open-label study involved 46 patients with hypothyroidism who had been on a stable oral levothyroxine regimen. Findings indicated that the average weekly dose of XP-8121 required was 45% less than the cumulative weekly dose of their oral medication. Additionally, participants reported higher satisfaction with the injectable treatment over oral administration, with 72% expressing a preference for the subcutaneous method due to factors such as convenience and ease of administration.
During the trial, the dose of XP-8121 was carefully titrated, starting at twice the daily oral dose and adjusting to a target of four times the daily dose. The final weekly dose averaged 324.4 mcg, with a dose conversion factor of 4.02 from the daily oral dose. The majority of treatment-emergent adverse events were mild to moderate in severity, with fatigue, injection site pain, and headache being the most common.
The study also highlighted the difficulties in maintaining normal thyroid-stimulating hormone (TSH) levels with daily oral levothyroxine therapy, as 40% of patients deemed stable at screening had TSH or T4 levels outside the normal range. Xeris aims to address these challenges with XP-8121, which could potentially improve patient outcomes and adherence to therapy.
Xeris is now looking forward to a meeting with the FDA expected by the end of the year, aiming to initiate a Phase 3 pivotal study program. Further details of the study are anticipated to be presented at upcoming medical meetings and submitted for peer review.
This news is based on a press release statement from Xeris Biopharma Holdings, Inc.
InvestingPro Insights
As Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) progresses with its promising XP-8121 study, the financial health of the company remains a key focus for investors. Xeris, with a market capitalization of $286.13M, reflects a relatively modest valuation in the biopharmaceutical space. The company's commitment to innovation is evident, but it's important to understand the financial metrics that may impact its ability to sustain drug development.
InvestingPro Data indicates that Xeris has experienced a significant 41.18% revenue growth over the last twelve months as of Q1 2024, which could be indicative of the company's potential to scale its operations. Despite this growth, the company's P/E ratio stands at -4.27, suggesting that investors are cautious about the company's profitability prospects in the near term. Furthermore, the gross profit margin is reported at a strong 82.9%, signaling efficient cost management relative to revenue.
An InvestingPro Tip highlights that Xeris is quickly burning through cash, which is a critical factor for investors to consider, given the company's current phase of development and the expensive nature of clinical trials. Additionally, another InvestingPro Tip reveals that analysts have revised earnings downwards for the upcoming period, which may reflect concerns about the company's future earnings potential.
For investors looking for more in-depth analysis and additional InvestingPro Tips, Xeris Biopharma Holdings, Inc. has a detailed profile on InvestingPro, which includes further metrics and insights. Interested readers can access these by visiting https://www.investing.com/pro/XERS. Moreover, there are 6 additional InvestingPro Tips available for Xeris, which can provide a more comprehensive understanding of the company's financial position and outlook.
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