Lumos to Highlight New LUM-201 Data and Analysis Presented at ENDO 2023 in Virtual KOL Webinar
June 21 2023 - 8:00AM
Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company
advancing an oral therapeutic candidate for idiopathic Pediatric
Growth Hormone Deficiency (iPGHD) through Phase 2 clinical trials,
is hosting today a virtual Key Opinion Leader (KOL) Webinar where
Drs. Fernando Cassorla and Michael Tansey will highlight the
encouraging new data and analysis on oral LUM-201 for idiopathic
PGHD from the Phase 2 PK/PD OraGrowtH212 and dose-finding
OraGrowtH210 Trials presented at the Endocrine Society (ENDO)
Annual Meeting, held in Chicago, Illinois, June 15-18, 2023.
The event will feature presentations by KOLs in
the field of pediatric endocrinology, Fernando Cassorla, MD, Chief
of Pediatric Endocrinology, University of Chile, and Michael
Tansey, MD, Clinical Professor of Pediatrics-Endocrinology and
Diabetes, University of Iowa, Carver College of Medicine, who will
review interim data from our Phase 2 OraGrowtH210 and OraGrowtH212
Trials presented at ENDO. Drs. Cassorla and Tansey will be
available to answer questions following their formal presentations.
To register for the virtual KOL Event, please click through the
link HERE.
Drs. Cassorla and Tansey gave two oral
presentations in the Update on Growth Disorders session at the 2023
ENDO Meeting. Presentation slides will be available from the Events
and Presentations section of the Lumos website.
Dose
Responsiveness of LUM-201 as Measured by Acute GH Response and
IGF-1 and Annualized Height Velocity (AHV) Measured at 6 Months in
the Interim Analysis of the OraGrowtH212 Study in Idiopathic
Pediatric Growth Hormone Deficiency (iPGHD)
(Fernando Cassorla, MD, Chief of Pediatric
Endocrinology, University of Chile)
- New data from
OraGrowtH212 trial shows durable response after 12 months of
LUM-201 administration
- Clear evidence
of potential drug effect observed in consistent improvement in
average height velocity over baseline
- Treatment with
LUM-201 increased serum IGF-1 concentration and SDS values, which
remained within normal range while contributing to meaningful
increases in height velocity
- Data support
physiologic mechanism of action of LUM-201
Growth
Response of Oral LUM-201 in OraGrowtH210 and OraGrowtH212 Trials in
Idiopathic Pediatric Growth Hormone Deficiency (iPGHD): Combined
Analysis Interim Analysis Data (Michael
Tansey, MD, Clinical Professor of Pediatrics-Endocrinology and
Diabetes, University of Iowa)
- Dr. Tansey
presented new analysis of combined interim data from two Phase 2
trials at the 1.6 mg/kg/day and 3.2 mg/kg/day doses, including 15
subjects from the OraGrowtH212 Trial and 20 subjects from the
OraGrowtH210 Trial
- Results of the
analysis of the additional OraGrowtH212 subjects combined with
OraGrowtH210 subjects continue to demonstrate that there is a
durable response to LUM-201 from 6 to 12 months
- Pre-treatment
baseline AHV data, which was not captured for all of the subjects
in our database, was available for 31 of the 35 subjects and showed
that LUM-201 at both the 1.6 mg/kg/day and 3.2 mg/kg/day produced
clinically meaningful increase in AHV from baseline
- No treatment
related Serious Adverse Events (SAEs), no discontinuation due to
AEs, and no meaningful safety signals observed
KOL Biographies
Fernando Cassorla, M.D. is currently Chief of
Pediatric Endocrinology at the Institute of Maternal and Child
Research of the University of Chile, a position he has held since
1993. Previously, beginning in 1979 Dr. Cassorla served as Senior
Investigator at the Developmental Endocrinology Branch of the
National Institute of Child Health and Human Development, rising to
the position of Clinical Director of this Institute in 1990. He has
authored numerous chapters in pediatric endocrinology, authored or
co-authored over 200 original articles in peer reviewed journals,
and has presented over 300 abstracts at scientific meetings. Dr.
Cassorla received his MD from the University of Chile. He is Board
Certified in both Pediatrics and Pediatric Endocrinology, having
completed his pediatric residency at the Albany Medical Center in
New York and his fellowship in Pediatric Endocrinology at the
Children´s Hospital of Philadelphia. Dr. Cassorla has received
several international awards for his work and was elected to the
Chilean Academy of Medicine for a lifetime position in 2003.
Michael Tansey, M.D. is currently Clinical
Professor, Department of Pediatrics, Division of Pediatric
Endocrinology and Diabetes, University of Iowa, Iowa City, Iowa, a
position he has held since 2012, having first served as Clinical
Assistant Professor there 2001-2006, then as Clinical Associate
Professor 2006-2012. Dr. Tansey also currently serves as Clinical
Director for Division of Pediatric Endocrinology and Diabetes,
Department of Pediatrics, University of Iowa. He has been a
co-investigator for one of the 5 clinical centers for the NIH
funded Diabetes Research in Children Network “DirecNet” group since
2001 and has co-authored numerous peer-reviewed scientific
publications on brain function and growth in children with Type 1
diabetes. Dr. Tansey received his MD from Loyola Stritch School of
Medicine, Maywood, Illinois, and completed his residency in
pediatrics and his fellowship in pediatric endocrinology at the
University of Iowa Children’s Hospital and University of Iowa
Hospitals and Clinics, respectively. He has received several awards
including the Riesz Award, University of Iowa, and the Mary Tyler
Moore and S. Robert Levine, MD, Excellence in Clinical Research
Award.
About Pediatric Growth Hormone Deficiency and
LUM-201
Pediatric Growth Hormone (GH) Deficiency is the consequence of
inadequate secretion of growth hormone from the pituitary gland in
children resulting in low GH in the body, insufficient production
of downstream signaling molecules required for growth, and the
subsequent lack of growth. LUM-201, also known as ibutamoren, is an
orally administered investigational small molecule that promotes
the secretion of GH from the pituitary gland and represents an
opportunity for moderate idiopathic PGHD patients – the majority of
the total PGHD population1 – to avoid the daily or weekly
injections involved with current or forthcoming therapies. LUM-201
has been observed to increase the amplitude of endogenous pulsatile
GH secretion, which mimics the natural pattern of GH secretion.
1 Blum et al JES 2021
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage
biopharmaceutical company focused on the development and
commercialization of therapeutics for rare diseases. Lumos Pharma
was founded and is led by a management team with longstanding
experience in rare disease drug development. Lumos Pharma’s lead
therapeutic candidate is LUM-201, an oral growth hormone
stimulating small molecule, currently being evaluated in several
Phase 2 clinical trials for the treatment of idiopathic Pediatric
Growth Hormone Deficiency (iPGHD): the dose-finding OraGrowtH210
Trial; the PK/PD mechanistic OraGrowtH212 Trial; and a switch
trial, the OraGrowtH213 Trial. If approved by the FDA, LUM-201
would provide an orally administered alternative to recombinant
growth hormone injections that PGHD subjects otherwise endure for
many years of treatment. LUM-201 has received Orphan Drug
Designation in both the US and EU. For more information, please
visit https://lumos-pharma.com/.
Investor & Media Contact:
Lisa MillerLumos Pharma Investor
Relations512-792-5454ir@lumos-pharma.com
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