Lumos Pharma Presents New Analyses from Phase 2 OraGrowtH212 Trial at ENDO 2024

Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company specializing in treatments for rare diseases, recently revealed new findings from its Phase 2 OraGrowtH212 clinical trial. These findings were presented in two posters at the 2024 Annual Meeting of the Endocrine Society (ENDO) held in Boston, MA, from June 1-4, 2024.

Dr. John C. McKew, President and Chief Scientific Officer of Lumos Pharma, highlighted the unique capability of LUM-201 to enhance the natural pulsatile secretion of growth hormone, effectively promoting growth comparable to injectable recombinant human growth hormone (rhGH) but with significantly less circulating hormone exposure. The data also support the company's proposed Phase 3 trial of LUM-201 for moderate Pediatric Growth Hormone Deficiency (PGHD), as suggested by the FDA.

The first poster, titled "Oral LUM-201 Restores Pulsatile Growth Hormone Secretion and Growth Response in Moderate Pediatric Growth Hormone Deficiency (PGHD): Key Discoveries from Phase 2 of OraGrowtH212 Trial," focused on the pulsatile growth hormone secretion analyzed at baseline and six months post-treatment with LUM-201. The results showed a notable increase in key parameters for the 1.6 mg/kg/day dose and similar increments for the 3.2 mg/kg/day dose cohort. The combined data suggested that LUM-201 restored endogenous growth hormone pulsatile secretion to levels comparable to those in normal children while also normalizing serum IGF-1 concentrations. The study concluded that LUM-201 could facilitate growth using a much lower amount of GH than daily exogenous rhGH, aligning with endocrine therapy objectives to restore normal hormonal homeostasis.

A second poster titled "Growth Response to Oral Growth Hormone Secretagogue LUM-201 in Children with Moderate GH Deficiency (GHD) is Dependent on the Pattern of Pulsatile GH Secretion Stimulated by LUM-201," explored the relationship between pulsatile GH profiles and growth response to LUM-201. Investigators utilized a univariate Spearman’s rank correlations matrix to screen for relationships between various parameters and growth responses at baseline and six months. They found that while all parameters increased from Day 1 to six months, the pattern of pulsatile secretion played a significant role in growth response. Specifically, the highest growth was linked to greater pulsatile activity early in the 12-hour profile.

Lumos Pharma is committed to developing LUM-201 as an oral therapeutic aimed at transforming the global GH market, which is currently valued at around $4.7 billion. The company is conducting multiple Phase 2 clinical studies on LUM-201 for PGHD and has received Orphan Drug Designation in both the US and EU.

The company emphasizes that future results or events could differ materially from current plans due to various risks and uncertainties. Despite their confidence and optimistic outlook, they recognize the unpredictability inherent in clinical development and market conditions.

In summary, Lumos Pharma's recent data presentations at the ENDO meeting underline the potential of LUM-201 to transform GH therapy by offering an effective oral alternative to injectable treatments, potentially bringing significant benefits to patients with PGHD.