AHV

Lumos Pharma Reports Full Year 2023 Financial Results and Provides Clinical Development Update

Retrieved on: 
Thursday, March 7, 2024
Research, CMO, Transgender hormone therapy, PIN, AHV, Investment, FDA, Endocrinology, LUMO, Webcast, Patient, Clinical trial, Initiation, Travel

AUSTIN, Texas, March 07, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a late-stage biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), today announced financial results for the year ended December 31, 2023 and provided an update on clinical and regulatory activity.

Key Points: 
  • We expect to be in position to initiate this registrational trial in the fourth quarter, pending positive feedback from the FDA.
  • Financial Results for the Year Ended December 31, 2023
    Cash Position – Lumos Pharma ended the year on December 31, 2023, with cash, cash equivalents, and short-term investments totaling $36.1 million compared to $67.4 million on December 31, 2022.
  • Cash on hand as of December 31, 2023, is expected to support operations through the third quarter of 2024.
  • ET today to discuss its financial results and to give an update on clinical programs.

BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia

Retrieved on: 
Wednesday, December 13, 2023
ENDO, Hypochondroplasia, Achondroplasia, AHV, Research, FDA, PALO, Murdoch, Cancer, PROPEL, Growth, Safety, Child, Pharmaceutical industry

PALO ALTO, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first child has been dosed in PROPEL 3, a Phase 3 clinical trial studying the efficacy and safety of infigratinib in children with achondroplasia. Both the U.S. FDA and the EU EMA indicated the trial design for PROPEL 3 would be acceptable as a registrational study to support a marketing application for the treatment of children with achondroplasia.

Key Points: 
  • “The Phase 2 data for infigratinib has been very promising and suggests potential to increase growth, improve functionality and reduce the associated medical complications in children with achondroplasia.
  • PROPEL 3 is a global, one-year, 2:1 randomized, double-blinded placebo-controlled clinical trial, which will evaluate the efficacy and safety of infigratinib in children with achondroplasia aged 3 to
  • Information about PROPEL (NCT04035811), BridgeBio’s observational lead-in study in achondroplasia for PROPEL 3 and other studies, can be found here on clinicaltrials.gov.
  • BridgeBio is committed to exploring the potential of infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasias, which hold significant unmet needs for families.

Lumos Pharma Announces Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints

Retrieved on: 
Tuesday, November 7, 2023
Research, ECG, PD, Injection, Injection (medicine), Comparable, Classification, AHV, Child, Transgender hormone therapy, PEM, KOL, University, Safety, Patient, LUMO, Unique, MD, Growth, Standard error, GH, Growth hormone, Coronavirus Scientific Advisory Board, FDA, Șaeș, Aes, Pediatric endocrinology, City of Hope National Medical Center, Mother, LSM, SDS, University of Chile, Political moderate, Silviculture, Vaccine, Pharmaceutical industry, Birth control, Wood drying, Online shopping, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO) today announced that topline results from its Phase 2 OraGrowtH210 dose-finding trial and its Phase 2 OraGrowtH212 Pharmacokinetic/Pharmacodynamic (PK/PD) trial met all primary and secondary endpoints. Data from the OraGrowtH210 Trial demonstrated annualized height velocity (AHV) on the 1.6 mg/kg dose of orally administered LUM-201 of 8.2 cm/yr at six months and 8.0 cm/yr at 12 months on treatment,* in line with historical data in moderate pediatric growth hormone deficiency (PGHD) patients and within the targeted 2 cm/yr margin of the comparator injectable recombinant growth hormone (rhGH) arm. Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program. Data from the OraGrowtH212 Trial confirmed that LUM-201’s unique pulsatile mechanism produces an increase in growth rates while restoring growth hormone secretion and IGF-1 to within normal ranges †, with levels substantially below those produced by exogenous injectable rhGH.†† Additionally, data from a small subset of 10 subjects combined 1.6 and 3.2 mg/kg dosage of LUM-201 in both OraGrowtH210 and OraGrowtH212 trials demonstrated the sustained effectiveness of AHV up to 24 months. Furthermore, the safety profile for LUM-201 remained clean throughout both Phase 2 studies, with no safety concerns identified in either of our Phase 2 trials conducted thus far.

Key Points: 
  • Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program.
  • The OraGrowtH210 trial met its primary objective, with 6-month AHV data of 8.2 cm/yr supporting the 1.6 mg/kg as the optimal dose for a Phase 3 clinical trial.
  • Eighteen and 24-month growth data were available for 10 subjects from the OraGrowtH210 and OraGrowtH212 Trials who met AHV criteria per protocol at 12 months.
  • Every participant in the OraGrowtH212 Trial met the criteria for Patient PEM positivity, ensuring their potential responsiveness to LUM-201.

Lumos Pharma Reports Third Quarter 2023 Financial Results and Clinical Development Updates

Retrieved on: 
Tuesday, November 7, 2023
Research, Transgender hormone therapy, American Association of Clinical Endocrinologists, Event, Child, LUMO, Pediatric endocrinology, Therapy, City of Hope National Medical Center, Rare, IGFBP3, Mother, MD, Quarter, SDS, Endocrine Society, Clinical trial, PEM, KOL, Lumos, University, Serum, University of Chile, Political moderate, European Society of Gynaecological Oncology, Growth hormone, Investment, Consistency, AHV, Silviculture, Pharmaceutical industry, Birth control, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced that topline results met primary and secondary endpoints for its Phase 2 Dose-Finding OraGrowtH210 Trial and Phase 2 Pharmacokinetic/Pharmacodynamic (PK/PD) OraGrowtH212 Trial evaluating oral LUM-201 for subjects with moderate pediatric growth hormone deficiency (PGHD) who screened PEM-positive utilizing Lumos Pharma’s predictive enrichment marker (PEM) strategy. Lumos also announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • Lumos also announced its financial results for the quarter ended September 30, 2023.
  • The Company expects cash use of approximately $9.0 to $10.0 million in the fourth quarter of 2023.
  • Net Loss – The net loss for the quarter ended September 30, 2023 was $8.3 million compared to a net loss of $7.3 million for the same period in 2022.
  • Lumos Pharma ended the third quarter 2023 with 7,914,582 shares outstanding.

Lumos Pharma Announces New Data and Analysis of 15 Subjects from OraGrowtH212 Trial Presented at the 2023 ESPE Annual Meeting

Retrieved on: 
Tuesday, September 26, 2023
IGFBP3, LUMO, Comparable, Time zone, Growth hormone, Serum, IGF, ESPE, Endocrine Society, Doctor of Philosophy, GH, Deconvolution, PEM, 2010 Formula Renault 3.5 Series, MD, Growth, Ageing, Patient, European Society for Paediatric Infectious Diseases, Poster, SD, AHV, Pharmaceutical industry, The Hague

“The presented results add to the growing body of evidence supporting the physiologic mechanism of action for LUM-201, as well as its potential as a treatment for moderate PGHD.

Key Points: 
  • “The presented results add to the growing body of evidence supporting the physiologic mechanism of action for LUM-201, as well as its potential as a treatment for moderate PGHD.
  • The slides presented at ESPE are available on the Posters & Publications page under the Investors & Media section of Lumos Pharma’s website.
  • At baseline, subjects (10M:5F) were (mean ± SD) aged 7.9±1.4 years, with IGF-1 SDS -0.82±0.9, and peak GH 7.2±2.2 ng/mL (clonidine stimulation), consistent with moderate PGHD.
  • Deconvolution analysis was performed on serum GH measured every 10 minutes (0800 h to 2000 h).

BridgeBio Pharma Announces Positive Feedback from the U.S. FDA and EU EMA on the Regulatory Path for a Pivotal Phase 3 Trial of Infigratinib in Children with Achondroplasia

Retrieved on: 
Wednesday, September 6, 2023
ENDO, Osteochondrodysplasia, FGFR3, Evelina London Children's Hospital, ASHG, Marketing, Pharming, PALO, Aes, Achondroplasia, Șaeș, EMA, Physician, Cancer, European, European Medicines Agency, Growth, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Food, Hypochondroplasia, Safety, Vaccine, Pharmaceutical industry, EU, AHV

”The regulatory feedback clearing the path to approval for infigratinib is great news for children living with achondroplasia and for physicians who treat them.

Key Points: 
  • ”The regulatory feedback clearing the path to approval for infigratinib is great news for children living with achondroplasia and for physicians who treat them.
  • ”We are thrilled to have regulatory alignment on key elements of our Phase 3 trial design and the path towards submitting a marketing application to both the FDA and the EMA.
  • Additionally, BridgeBio expects to initiate clinical development for infigratinib in hypochondroplasia, a skeletal dysplasia closely related to achondroplasia and similarly driven by FGFR3 gain-of-function variants.
  • BridgeBio has previously presented promising preclinical data for hypochondroplasia at ENDO 2023 and ASHG 2022.

Genexine’s long-acting growth hormone meets Phase 3 primary endpoint

Retrieved on: 
Thursday, August 31, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, AHV, Alfa, Safety, Pharmaceutical industry, Silviculture

The study being conducted by Genexine’s partner in China, I-Mab, met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin®.

Key Points: 
  • The study being conducted by Genexine’s partner in China, I-Mab, met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin®.
  • Eftansomatropin alfa was given by weekly injection vs. Norditropin® given by daily injection.
  • Eftansomatropin alfa was well tolerated and no drug discontinuation was reported due to treatment related adverse events.
  • We remain committed to our efforts to commercialize our leading products in various key markets.”

Lumos Pharma Reports Second Quarter 2023 Financial Results, Provides Clinical Update

Retrieved on: 
Wednesday, August 9, 2023
ENDO, LUMO, KOL, Non-alcoholic fatty liver disease, Bank statement, SDS, Clinical trial, ESPE, GH, PIN, User experience, Investment, Webcast, NAFLD, Growth, Research, Transgender hormone therapy, AHV, Pharmaceutical industry, Birth control, Dietary supplement, Medical device, The Hague

Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar

Key Points: 
  • Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar
    AUSTIN, Texas, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc .
  • (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, today announced financial results for the second quarter ended June 30, 2023.
  • Cash on hand as of June 30, 2023 is expected to support operations for at least 12 months following the date of the filing of our second quarter 2023 financial statements.
  • ET today to discuss its financial results and to give an update on clinical programs.

Lumos to Highlight New LUM-201 Data and Analysis Presented at ENDO 2023 in Virtual KOL Webinar

Retrieved on: 
Wednesday, June 21, 2023
ENDO, Roy J. and Lucille A. Carver College of Medicine, Senior, Serum, Pediatric endocrinology, SDS, DRS, MD, Division, Update, Transgender hormone therapy, LUMO, Database, University, Mother, University of Iowa Hospitals and Clinics, Albany Medical Center, Lumos, Growth, Hospital, NIH, Abstract, Endocrinology, Aes, University of Chile, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Șaeș, Public key certificate, Endocrine Society, Research, KOL, Saint Andrew's Society, University of Iowa, Oral, Diabetes, AHV, Pharmaceutical industry, Nursing, Dietary supplement, Child, Pediatrics

AUSTIN, Texas, June 21, 2023 (GLOBE NEWSWIRE) -- 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.

Key Points: 
  • 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.
  • 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 .
  • Cassorla and Tansey gave two oral presentations in the Update on Growth Disorders session at the 2023 ENDO Meeting.

BridgeBio Pharma Presents Updated Six Month Results from its Phase 2 Cohort 5 Trial of Infigratinib in Achondroplasia at the Endocrine Society (ENDO) 2023 Annual Conference

Retrieved on: 
Tuesday, June 20, 2023
ENDO, Osteochondrodysplasia, FGFR3, Partnership, Cohort, PALO, Aes, Infigratinib, Hypoparathyroidism, Saint Andrew's Society, Achondroplasia, Research, IP, Șaeș, Murdoch, Patient, Physician, CXM, Cancer, Endocrine Society, Growth, Conference, Treatment, DSM-IV codes, Hypochondroplasia, Autosome, Pharmaceutical industry, Nursing, AHV

Infigratinib is an oral small molecule designed to inhibit FGFR3 and target achondroplasia at its source.

Key Points: 
  • Infigratinib is an oral small molecule designed to inhibit FGFR3 and target achondroplasia at its source.
  • The Phase 2 trial was designed to identify the dose of infigratinib that will be explored in the Phase 3 trial.
  • Our data also presents the opportunity for us to move forward quickly in initiating a Phase 3 clinical trial.
  • Based on the positive results to date, BridgeBio is underway in enrolling children in the run-in for a Phase 3 trial.