OX2R

Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024

Retrieved on: 
Monday, April 22, 2024
Volunteering, FDA, Safety, Pharmacokinetics, Sleep, Food, CNTA, MWT, NT2, Idiopathic hypersomnia, IND, IH, SAD, POC, Patient, Narcolepsy, NT1, OX2R, Clinical trial, PD, Investigational New Drug, KSS, Pharmaceutical industry

The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects.

Key Points: 
  • The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects.
  • The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024.
  • “We are excited to begin executing what we believe is an elegant, adaptive Phase 1 study aimed at generating early proof-of-concept data for ORX750 in acutely sleep-deprived healthy volunteers in the second half of this year.
  • We expect this study to enable dose selection for planned studies evaluating ORX750 in patients with NT1 and in patient populations with normal orexin levels, including NT2 and IH.”

HARMONY BIOSCIENCES ANNOUNCES EXCLUSIVE AGREEMENT TO DEVELOP AND COMMERCIALIZE TPM-1116, A HIGHLY POTENT AND SELECTIVE ORAL OREXIN-2 RECEPTOR AGONIST

Retrieved on: 
Thursday, April 11, 2024
Hypothalamus, Sleep disorder, Research, Narcolepsy, Patient, Histamine, Harmony, OX2R, Pharmaceutical industry

PLYMOUTH MEETING, Pa., April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders.

Key Points: 
  • PLYMOUTH MEETING, Pa., April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders.
  • Narcolepsy and other hypersomnolence disorders continue to be a large market opportunity with significant unmet medical need.
  • Under the agreement, Harmony will pay Bioprojet an upfront license fee of $25.5 million for the exclusive right to develop, manufacture and commercialize TPM-1116 in the U.S. and Latin American territories.
  • Finally, Harmony will pay a royalty rate in the mid-teens on sales of product in the licensed territories.

Centessa Pharmaceuticals Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2023

Retrieved on: 
Thursday, March 28, 2024
Narcolepsy, Toxicity, Administration, Development, ASH, ABR, Haemophilia, Part, APC, Tumor microenvironment, Observation, Volunteering, Trial of the century, CD47, Investment, Society, Bleeding, CNTA, ATM, Safety, OX2R, Sleep, Person, Pharmaceutical industry

“This is an exciting and pivotal time for Centessa,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.

Key Points: 
  • “This is an exciting and pivotal time for Centessa,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.
  • Cash, Cash Equivalents and Short-term Investments: $256.5 million as of December 31, 2023, which includes approximately $6.2 million in net proceeds through ATM sales in the fourth quarter ended December 31, 2023.
  • General & Administrative Expenses: $12.3 million for the fourth quarter ended December 31, 2023, compared to $13.8 million the fourth quarter ended December 31, 2022, and $53.7 million for the full-year 2023 compared to $55.2 million for the full-year 2022.
  • Net Loss Attributable to Ordinary Shareholders: $36.8 million for the fourth quarter ended December 31, 2023, compared to $43.2 million for the fourth quarter ended December 31, 2022, and $151.1 million for the full-year 2023 compared to $216.2 million for the full-year 2022.

Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024

Retrieved on: 
Thursday, February 8, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, MRCP, Hepatotoxicity, NT2, Neurological disorder, Narcolepsy, WCR, Fiscal, Wakefulness, Caregiver, Head, Patient, ESS, DSM-IV codes, Medicine, Neuron, OX2R, Disease, Epworth Sleepiness Scale, MWT, Pharmaceutical industry

It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.

Key Points: 
  • It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.
  • Stimulating the orexin receptor 2 in NT1 patients targets the underlying pathophysiology of the disease to restore orexin signaling.
  • Based on these results, and in consultation with global health authorities, Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 rapidly in the first half of its fiscal year 2024.
  • Results from the Phase 2b trials have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Third Quarter of 2023

Retrieved on: 
Monday, November 13, 2023
Safety, Haemophilia, APC, ASH, Narcolepsy, CNTA, Administration, Patient, Investment, Sleep, Part, Neoplasm, OX2R, Trial of the century, Development, Congress, Society, Volunteering, World Sleep Day, Rare-earth element, Pharmaceutical industry, Palladium, Cryptocurrency, IND

Data from Part 5 of the ongoing Phase 2a study accepted for poster presentation at ASH on December 10, 2023.

Key Points: 
  • Data from Part 5 of the ongoing Phase 2a study accepted for poster presentation at ASH on December 10, 2023.
  • Research & Development Expenses: $28.2 million for the third quarter ended September 30, 2023, compared to $36.7 million for the third quarter ended September 30, 2022.
  • General & Administrative Expenses: $12.0 million for the third quarter ended September 30, 2023, compared to $12.3 million for the third quarter ended September 30, 2022.
  • Net Loss Attributable to Ordinary Shareholders: $38.6 million for the third quarter ended September 30, 2023, compared to $53.9 million for the third quarter ended September 30, 2022.

Centessa Pharmaceuticals Announces Preclinical Data Supporting ORX750’s Potential as a Best-in-Class Oral OX2R Agonist for the Treatment of Narcolepsy and Other Sleep-Wake Disorders

Retrieved on: 
Wednesday, October 25, 2023
IH, BRT, Wakefulness, Sleep, Cataplexy, IND, NT2, Human, Congress, Narcolepsy, Electromyography, DTA, Idiopathic hypersomnia, OX2R, OX1R, PK, EC50, EMG, EEG, CHO, Patient, CNTA, Pharmaceutical industry, Aroma compound, Surat Bus Rapid Transit System, NT1

BOSTON and LONDON, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced a robust set of new preclinical data from in vivo and in vitro studies of its investigational, novel orexin receptor 2 (OX2R) agonist, ORX750, that support its potential best-in-class profile for the treatment of narcolepsy and other sleep-wake disorders.

Key Points: 
  • “The preclinical data showed ORX750 achieved maximal wake times and suppressed cataplexy at 0.1 mg/kg, the lowest oral dose tested in the DTA mouse model.
  • Notably, this activity was observed in both the DTA and Atax mouse models that recapitulate NT1 symptoms in humans.
  • Fluorescent imaging plate reader (FLIPR) assay with Chinese hamster ovary (CHO) cells stably expressing recombinant human OX1R or OX2R; OXA EC50 at hOX2R = 0.035 nM.
  • As measured by electroencephalogram (EEG) and electromyogram (EMG) with concurrent video in DTA and Atax mouse models.

Alkermes Presents First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress

Retrieved on: 
Monday, October 23, 2023
DSM-IV codes, MWT, Wireless ambulatory ECG, Congress, Pathology, Dizziness, Idiopathic hypersomnia, Maintenance, Alkermes, Pharmacokinetics, Sleep, Urination, OX2R, Dysfunction, Disease, NT1, Biology, Wakefulness, Sleep onset latency, Safety, Vital signs, ALKS, Patient, Insomnia, Pharmaceutical industry, Narcolepsy

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia via once-daily, oral administration. Initial data from the single- and multiple-ascending dose evaluations in healthy volunteers and the first cohort of four patients with narcolepsy type 1 (NT1) will be presented today at the 2023 World Sleep Congress in Rio de Janeiro.

Key Points: 
  • In the four patients with NT1, treatment with ALKS 2680 demonstrated improved sleep latency compared to placebo at all doses tested, with a clear dose response.
  • The differences between ALKS 2680 and placebo were statistically significant for all doses: 1 mg (p
  • Treatment with ALKS 2680 resulted in clinically meaningful improvements in MWT from baseline at all doses tested.
  • "These initial data support our design rationale for ALKS 2680 as a highly potent, orally bioavailable, selective orexin 2 receptor agonist designed to address the underlying pathology of narcolepsy.

Alkermes Presents First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress

Retrieved on: 
Monday, October 23, 2023
DSM-IV codes, MWT, Wireless ambulatory ECG, Congress, Pathology, Dizziness, Idiopathic hypersomnia, Maintenance, Alkermes, Pharmacokinetics, Sleep, Urination, OX2R, Dysfunction, Disease, NT1, Biology, Wakefulness, Sleep onset latency, Safety, Vital signs, ALKS, Patient, Insomnia, Pharmaceutical industry, Narcolepsy

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia via once-daily, oral administration. Initial data from the single- and multiple-ascending dose evaluations in healthy volunteers and the first cohort of four patients with narcolepsy type 1 (NT1) will be presented today at the 2023 World Sleep Congress in Rio de Janeiro.

Key Points: 
  • In the four patients with NT1, treatment with ALKS 2680 demonstrated improved sleep latency compared to placebo at all doses tested, with a clear dose response.
  • The differences between ALKS 2680 and placebo were statistically significant for all doses: 1 mg (p
  • Treatment with ALKS 2680 resulted in clinically meaningful improvements in MWT from baseline at all doses tested.
  • "These initial data support our design rationale for ALKS 2680 as a highly potent, orally bioavailable, selective orexin 2 receptor agonist designed to address the underlying pathology of narcolepsy.

Alkermes to Present First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress

Retrieved on: 
Tuesday, October 10, 2023
Congress, Neuroscience, BRT, Pharmacokinetics, Idiopathic hypersomnia, Cataplexy, Risk factor, ALKS, Safety, Wakefulness, Risk, Signs and symptoms, Model, OX2R, Investigational New Drug, Diagnosis, Pharmaceutical industry, Alkermes, Narcolepsy, Patient

DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro. In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia. This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.

Key Points: 
  • — Oral Presentation to Include Initial Clinical Proof-of-Concept Data in Patients With Narcolepsy Type 1 for ALKS 2680, the Company's Investigational Orexin 2 Receptor Agonist —
    DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro.
  • In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia.
  • This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.
  • We look forward to presenting data at the World Sleep Congress, including our first clinical data for ALKS 2680 in patients with narcolepsy."

Alkermes to Present First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress

Retrieved on: 
Tuesday, October 10, 2023
Congress, Neuroscience, BRT, Pharmacokinetics, Idiopathic hypersomnia, Cataplexy, Risk factor, ALKS, Safety, Wakefulness, Risk, Signs and symptoms, Model, OX2R, Investigational New Drug, Diagnosis, Pharmaceutical industry, Alkermes, Narcolepsy, Patient

DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro. In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia. This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.

Key Points: 
  • — Oral Presentation to Include Initial Clinical Proof-of-Concept Data in Patients With Narcolepsy Type 1 for ALKS 2680, the Company's Investigational Orexin 2 Receptor Agonist —
    DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro.
  • In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia.
  • This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.
  • We look forward to presenting data at the World Sleep Congress, including our first clinical data for ALKS 2680 in patients with narcolepsy."