KOL Review of Lumos Pharma’s Interim Phase 2 Data Supports Potential for New Oral Therapeutic Paradigm for Moderate Idiopathic PGHD Patients
“Lumos Pharma was delighted to host Drs.
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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
Drawing from their experience in the clinic,
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
We are passionate about our business - including LUM-201 and the potential it may have to help patients in the clinic. This passion feeds our optimism that our efforts will be successful and bring about meaningful change for patients. Please keep in mind that actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make.
We have attempted to identify forward-looking statements by using words such as “projected,” "upcoming," "will," “would,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” and similar references to future periods or the negative of these terms. Not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding progress in our clinical efforts including comments concerning screening and enrollment for our trials, expecting the primary outcome data readout for our trials, the potential to expand our LUM-201 platform into other indications, anticipated market reception to our treatment regimen for PGHD and other indications, plans related to initiation and execution of clinical trials; plans related to moving additional indications into clinical development; future financial performance, results of operations, cash position and sufficiency of capital resources to fund our operating requirements through the primary outcome data readout from the OraGrowtH210 and OraGrowtH212 Trials, and any other statements other than statements of historical fact.
We wish we were able to predict the future with 100% accuracy, but that just is not possible. Our forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements contained in this announcement are made as of this date and Lumos undertakes no duty to update such information except as required under applicable law. You should not rely on any of these forward-looking statements and, to help you make your own risk determinations, we have provided an extensive discussion of risks that could cause actual results to differ materially from our forward-looking statements in the "Risk Factors" section and elsewhere in Lumos Pharma’s Annual Report on Form 10-K for the year ended
We anticipate that subsequent events and developments will cause our views to change. We may choose to update these forward-looking statements at some point in the future, however, we disclaim any obligation to do so. As a result, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
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Source: Lumos Pharma, Inc.