Lumos Pharma, Inc. (LUMO) Announces KOL Review of Interim Phase 2 Data Supports Potential for New Oral Therapeutic Paradigm for Moderate Idiopathic PGHD Patients
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Lumos Pharma, Inc. (NASDAQ: LUMO), a clinical-stage biopharmaceutical company focused on rare disorders, hosted two key opinion leaders (KOLs) in the field of pediatric endocrinology on December 6th to review the Company’s interim data from two Phase 2 trials evaluating oral LUM-201 in moderate idiopathic Pediatric Growth Hormone Deficiency (iPGHD). Andrew Dauber, MD, MMSc, Chief of Endocrinology, Children’s National Hospital, and Fernando Cassorla, MD, Chief of Pediatric Endocrinology, University of Chile, discussed recently released (on November 14, 2022) and new interim data (presented on December 6, 2022) from two ongoing OraGrowtH trials.
“Lumos Pharma was delighted to host Drs. Andrew Dauber and Fernando Cassorla, investigators in our OraGrowtH210 and OraGrowtH212 trials, respectively, to share their insights about oral LUM-201 and its potential to treat children with moderate idiopathic PGHD,” said Rick Hawkins, Chairman and CEO of Lumos Pharma. “For the last 40 years, these children have had only injectable growth hormone as a treatment option. In their discussion, both Dr. Dauber and Dr. Cassorla highlighted interim clinical data that supports the potential for LUM-201 as a welcome oral alternative to current therapies that require frequent injections.”
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Highlights from Dr. Andrew Dauber’s Discussion of Interim Phase 2 OraGrowtH210 Results
- LUM-201, an oral growth hormone secretagogue, has a unique mechanism of action, targeting specific receptors on the pituitary and hypothalamus to stimulate the natural pulsatile secretion of growth hormone for moderate idiopathic PGHD patients with an intact pituitary-hypothalamic axis
- Reviewed the Interim Phase 2 OraGrowtH210 data announced on November 14, 2022. Reiterated that the annualized growth of 8.6 cm/year at 6 months on 1.6 mg/kg/day of LUM-201 met expectations of 8.3-8.5 cm/year annualized growth at 12 months on therapy established across multiple large datasets of moderate idiopathic PGHD patients on daily rhGH1,2,3,4
- Outsized growth in the trial’s control arm of 10 subjects was likely due to imbalances of baseline characteristics in that arm compared to the 31 subjects across the LUM-201 arms and would likely resolve at full enrollment of 80 subjects in the Phase 2 trial and would not likely be repeated in a large Phase 3 trial
- Safety and tolerability for LUM-201 appear comparable to rhGH in this study period
Highlights from Dr. Fernando Cassorla’s Discussion of Interim PK/PD OraGrowtH212 Results
- New data: A stimulation dose of 0.8 mg/kg LUM-201 produces a substantial growth hormone (GH) response
- New data: LUM-201 at 1.6 and 3.2 mg/kg/day produced a substantial increase in height velocity at 6 months versus baseline for all 10 subjects evaluated in the interim analysis of the OraGrowtH212 Trial
- New data: Substantial increases in growth hormone (GH) area under the curve (AUC) and IGF-1 levels at 6 months on both doses of LUM-201 compared to baseline were also observed
- New baseline data showing age and Height SDS values for OraGrowtH212 was presented which suggest that the 3.2 mg cohort was somewhat more growth hormone deficient than the 1.6 mg cohort, likely explaining the seemingly faster growth seen in the 3.2 mg/kg/day LUM-201 cohort
1 Blum et al JES 2021, 2 Lechuga-Sancho et al JPEM 2009, 3 Ranke et al JCEM 2010, 4 Bright et al JES 2021.
Drawing from their experience in the clinic, Dr. Dauber and Dr. Cassorla noted the compliance issues with the injectable growth hormone, the only current treatment option for PGHD, supporting the potential for an oral therapeutic like LUM-201 to potentially improve compliance for their moderate idiopathic PGHD patients. Both doctors commented that there were also a number of patients currently not receiving treatment for PGHD because of their aversion to injections. Dr. Dauber and Dr. Cassorla acknowledged that it was likely that an oral therapeutic like LUM-201 would appeal to this latter population, potentially expanding the market for PGHD therapies.
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