Updated Phase 2 OraGrowtH Data Presented at ESPE 2024 Demonstrate Sustained Growth on Oral LUM-201 to 24 Months in PGHD and Correlation of Growth to LUM-201’s Unique Pulsatile Mechanism of Action
November 21 2024 - 8:00AM
Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage
biopharmaceutical company focused on therapeutics for rare
diseases, announced that new analyses of data from its Phase 2
OraGrowtH210 and OraGrowtH212 clinical trials were presented orally
at the 62nd Annual European Society for Paediatric Endocrinology
Meeting, or ESPE 2024, held November 16-18, 2024 in Liverpool, UK.
“The new analyses and updated data from our
Phase 2 OraGrowtH210 and OraGrowtH212 Trials presented at ESPE this
week demonstrate sustained growth on LUM-201 in moderate Pediatric
Growth Hormone Deficiency (PGHD) to 24 months, as well as the
correlation of LUM-201’s pulsatile mechanism of action (MOA) to
growth,” said John C. McKew, PhD, President and Chief Scientific
Officer of Lumos Pharma. “We are encouraged by these data and look
forward to advancing oral LUM-201 in a Phase 3 clinical trial in
moderate PGHD next year.”
In the oral presentation of Abstract FC7.6 on
Sunday, November 17th, entitled, Growth, IGF-1 and IGFBP-3
Responses to Oral LUM-201 in OraGrowtH210 and OraGrowtH212 Trials
in Pediatric Growth Hormone Deficiency (PGHD) Over 12 to 24 Months
on Treatment (Elżbieta Petriczko, MD, PhD, et al) [link], the
investigator reviewed updated combined data from the Phase 2
OraGrowtH210 and OraGrowtH212 Trials out to 24 months following
treatment with LUM-201.
- Results showed that at six months
on LUM-201, a significant increase over baseline in Annualized
Height Velocity (AHV) was observed for the combined 1.6 and 3.2
mg/kg/day doses. At baseline, AHV was 4.6 cm/yr for 37 subjects for
which baseline data were available vs 7.8 cm/yr at 6 months on
LUM-201 for 66 subjects.
- Results also showed that growth
rates on oral LUM-201 (combined 1.6 and 3.2 mg/kg dose cohorts)
were sustained out to 24 months with AHVs of 7.3 (N=65), 7.5
(N=36), and 7.3 (N=20) cm/yr at 12, 18, and 24 months, respectively
[graphic below].
- Combined results also demonstrated
significant increases in IGF-1 and IGFBP-3 levels from baseline out
to 24 months, with IGF-1 increasing from 13.1 (baseline) to 25.5
(12 months) to 29.2 (24 months) nmol/L and IGFBP-3 increasing from
133.5 (baseline) to 179.6 (12 months) to 186.2 (24 months)
nmol/L.
- Conclusions:
LUM-201 shows a significant increase in AHV at 6 months, and the
effect continues with a minimal decrease in AHV through 24 months.
Compared to historical rhGH (KIGS)1, LUM-201 has a smaller drop in
AHV from 12 months to 24 months. LUM-201 significantly increases
IGF-1 and IGFBP-3 levels at 12 months which continues to 24 months.
A favorable investigational safety profile has been observed to
date.
In the late-breaking oral presentation of
Abstract FC15.2 on Monday, November 18th, entitled, Amount and
Pattern of Pulsatile GH Secretion Induced by the Oral Growth
Hormone Secretagogue LUM-201 Is Related to Growth and IGF-1
Responses in Moderate Pediatric Growth Hormone Deficiency (PGHD)
(Peter E. Clayton, MD, et al) [link], the investigator reviewed
data from OraGrowtH212 demonstrating the relationship between
pulsatile GH profiles and both the growth and IGF-1 responses to
LUM-201 treatment.
- Data from 22 prepubertal children
with moderate PGHD from the OraGrowtH212 Trial were evaluated with
subjects grouped into tertiles based on 6-month annualized height
velocity (AHV).
- Pulsatile growth hormone (GH) pulse
assessments at baseline and at 6 months (M6) were characterized
using 1) Approximate Entropy (ApEn, scale 0-1) examining degree of
orderliness over the whole profile and 2) Functional Principal
Component Analysis (FPCA) identifying where within the 12-hour
profile, divided into 4-hour periods, the dominant variation
occurred.
- Results of 6-month treatment with
LUM-201:
- Pulsatile GH secretion, ApEn, IGF-1
SDS and IGFBP-3 SDS increased from baseline to M6.
- Greater M6 AHV was associated with
an earlier periodicity of augmented pulsatile GH secretion [graphic
below].
- Conclusion: Both
amount and pattern of GH secretion are important for growth and
IGF-1 responses to LUM-201.
1 Ranke et al., 2010 – Pfizer KIGS database rhGH treated cohort
of moderate prepubertal GHD children.
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage
biopharmaceutical company focused on the development and
commercialization of therapeutics for rare diseases. The Company
was founded and is led by a management team with longstanding
experience in rare disease drug development. Lumos Pharma’s lead
therapeutic candidate, LUM-201, is a novel, oral growth hormone
(GH) secretagogue, seeking to transform the ~$4.7B global
GH market from injectable to oral therapy. LUM-201 is currently
being evaluated in multiple Phase 2 clinical studies in Pediatric
Growth Hormone Deficiency (PGHD) and has received Orphan Drug
Designation in both the US and EU. For more information, please
visit https://lumos-pharma.com/.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements of Lumos Pharma, Inc. that involve substantial
risks and uncertainties. All such statements contained in this
press release are forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. A law that,
in part, gives us the opportunity to share our outlook for the
future without fear of litigation if it turns out our predictions
were not correct.
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 the
advancement of oral LUM-201 to Phase 3, the potential for LUM-201
to be the first oral therapeutic for PGHD, 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. 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 including risks related to the timing and ability of
Lumos Pharma to structure our Phase 3 trial in an effective and
timely manner, the ability to initiate and advance a pivotal Phase
3 trial, as well as advance our clinical and corporate strategy in
general, our ability to project future cash utilization and
reserves needed for contingent future liabilities and business
operations, the ability to successfully develop our product
candidate, the effects of pandemics, other widespread health
problems or military conflicts including
the Ukraine-Russia conflict and the Middle
East conflict and other risks that could cause actual results
to differ materially from those matters expressed in or implied by
such forward-looking statements including information in the "Risk
Factors" section and elsewhere in Lumos Pharma’s Quarterly Report
on Form 10-Q for the period ended September 30, 2024, as well
as other subsequent reports filed with the SEC. All of
these documents are available on our website. Before making any
decisions concerning our stock, you should read and understand
those documents.
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.
Investor & Media Contact:
Lisa MillerLumos Pharma Investor
Relations512-792-5454ir@lumos-pharma.com
Photos accompanying this announcement are available
athttps://www.globenewswire.com/NewsRoom/AttachmentNg/f1abdd2c-307b-47bb-8cc9-3c555fe00c85https://www.globenewswire.com/NewsRoom/AttachmentNg/b168603b-a009-4bce-a4d1-94367f1568ec
Source: Lumos Pharma, Inc.
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