Tuberous sclerosis complex tumor suppressors

Briefing on Capitol Hill Urges More Government Action and Investment in the Epilepsies

Retrieved on: 
Wednesday, May 24, 2023
Epilepsy, Seizure, FY, Capitol Hill, Traumatic brain injury, Research program, SCN8A, Quality of life, Human, Tuberous sclerosis, Research, Child, Doctor of Philosophy, Government, Organization, TSC, Congress, National Hospital for Neurology and Neurosurgery, Children's National Hospital, Patient, Epilepsy Foundation, Tuberous sclerosis complex tumor suppressors, Fiscal year, Letter, Neurology, Pharmaceutical industry, SUDEP

WASHINGTON, May 24, 2023 /PRNewswire/ -- In cooperation with the Congressional Epilepsy Caucus, organizations including the Epilepsy Foundation, Epilepsies Action Network, CURE Epilepsy, Rare Epilepsy Network and DEE-P Connections hosted a briefing on Capitol Hill on May 17 to educate about the epilepsies and call for more government action and investment in the epilepsies.

Key Points: 
  • WASHINGTON, May 24, 2023 /PRNewswire/ -- In cooperation with the Congressional Epilepsy Caucus, organizations including the Epilepsy Foundation, Epilepsies Action Network, CURE Epilepsy, Rare Epilepsy Network and DEE-P Connections hosted a briefing on Capitol Hill on May 17 to educate about the epilepsies and call for more government action and investment in the epilepsies.
  • (R-NC-3) and Jim Costa (D-CA-21) spoke about their personal connections to epilepsy and the importance of the caucus.
  • "My son developed epilepsy when he was 14 and it took us months to get the right treatment for him," said Congressman Murphy.
  • The annual total healthcare burden for people living with the epilepsies and/or seizures is at least $54 billion.

Noema Pharma Raises CHF 103 Million (USD 112 Million) in Series B Financing Round Led by Forbion and Jeito Capital

Retrieved on: 
Tuesday, March 7, 2023
Depression, Noema, Tourette syndrome, Stuttering, Investment, Polaris Partners, INVU (song), PDE10A, Glutamate (neurotransmitter), CHF, Myenteric plexus, Trigeminal neuralgia, Tuberous sclerosis complex tumor suppressors, CNS, Knowledge, Pain, Research, Seizure, Drug development, TSC, Patient, Sofinnova, News, Series, Central nervous system disease, General partnership, Atypical depression, COFD, Pharmaceutical industry

The round was co-led by leading European healthcare focused investment firms Forbion and Jeito Capital.

Key Points: 
  • The round was co-led by leading European healthcare focused investment firms Forbion and Jeito Capital.
  • Following the close of the Series B financing, Nanna Lüneborg from Forbion and Rachel Mears from Jeito Capital will join the Board of Directors of Noema Pharma.
  • USD 60 million) Series A financing concluded in December 2020, led by Sofinnova Partners and Polaris Partners.
  • Noema Pharma was founded in 2019 with a seed investment from Sofinnova Partners and four clinical stage assets in-licensed from Roche.

Jeito Capital co-leads a EUR 104 million financing in Noema Pharma, a clinical-stage biopharma company targeting debilitating central nervous system disorders

Retrieved on: 
Tuesday, March 7, 2023
Depression, Doctor of Philosophy, Growth, Tourette syndrome, Polaris Partners, Binge eating disorder, INVU (song), CHF, Safety, Trigeminal neuralgia, Tuberous sclerosis complex tumor suppressors, CNS, Knowledge, Capital, Face, Seizure, DSM-IV codes, Drug development, Patient, Sofinnova, News, Central nervous system disease, Do Meu Jeito, MD, Acceleration, UPMC, Fine chemical, Pharmaceutical industry, Noema

USD 112 million) financing in Noema Pharma (the “Company”), a clinical-stage biopharma company targeting debilitating central nervous system (CNS) disorders.

Key Points: 
  • USD 112 million) financing in Noema Pharma (the “Company”), a clinical-stage biopharma company targeting debilitating central nervous system (CNS) disorders.
  • As part of its indication expansion strategy, the Company also anticipates initiating clinical development in Atypical Depression and Binge Eating Disorders.
  • Jeito selected Noema Pharma in line with its investment strategy of supporting the development of the most promising European biopharma companies with high growth and acceleration potential.
  • This financing comes at a key time for Noema Pharma as we look forward to extensive news flow over the next 24 months.”

Noema Pharma, Founded by Sofinnova Partners, Raises CHF 103 Million (USD 112 Million) in Series B Financing

Retrieved on: 
Tuesday, March 7, 2023
Other Professional Services, Biotechnology, Pharmaceutical, Finance, General Health, Health, Professional Services, Clinical Trials, Polaris Partners, PDE10A, Partner, Atypical depression, Series A round, Tuberous sclerosis complex tumor suppressors, Sofinnova, News, COFD, CHF, Central nervous system disease, Patient, INVU (song), Tourette syndrome, TSC, Glutamate (neurotransmitter), CNS, Pain, Depression, Series, Seizure, Stuttering, Trigeminal neuralgia, Pharmaceutical industry, Noema

Sofinnova Partners (“Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced that Noema Pharma (“Noema”), has raised an oversubscribed CHF 103 million (approx.

Key Points: 
  • Sofinnova Partners (“Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced that Noema Pharma (“Noema”), has raised an oversubscribed CHF 103 million (approx.
  • This financing comes at a key time for Noema Pharma as we look forward to extensive news flow over the next 24 months.”
    The Series B financing follows a CHF 54 million (approx.
  • USD 60 million) Series A financing concluded in December 2020, led by Sofinnova Partners and Polaris Partners.
  • Noema Pharma was founded in 2019 with a seed investment from Sofinnova Partners and four clinical stage assets in-licensed from Roche.

Noema Pharma Receives FDA Fast Track Designation for basimglurant (NOE-101) in Trigeminal Neuralgia

Retrieved on: 
Tuesday, October 18, 2022
Physician, Tourette syndrome, Disease, Columbia University Irving Medical Center, Review, IND, Tuberous sclerosis complex tumor suppressors, US Foods, Glutamate (neurotransmitter), PDE10A, Trigeminal nerve, Patient, Investigational New Drug, Pain management, Seizure, Addiction medicine, Food, Trigeminal neuralgia, Neurology, Company, Basimglurant, Sofinnova, Pain, Face, Safety, Adult, Neuropathic pain, CNS, GLOBE, Fast Track, Brain, Polaris Partners, FDA, Principal, Pharmaceutical industry, Anesthesia, Biotechnology

BASEL, Switzerland, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces that the US Food and Drug Administration (FDA) has granted Fast Track designation to its mGluR5 inhibitor basimglurant (NOE-101) for the treatment of trigeminal neuralgia (TN).

Key Points: 
  • BASEL, Switzerland, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces that the US Food and Drug Administration (FDA) has granted Fast Track designation to its mGluR5 inhibitor basimglurant (NOE-101) for the treatment of trigeminal neuralgia (TN).
  • "We are very pleased to receive Fast Track designation from the FDA, which is intended to bring promising medicines to patients sooner, and very much underlines the potential of basimglurant in pain management associated with TN," said George Garibaldi MD, President, Head of R&D of Noema Pharma.
  • The FDA authorized Noema Pharma's Investigational New Drug (IND) application to initiate a Phase 2/3 clinical trial of basimglurant in TN in February 2022.
  • Basimglurant, an mGluR5 inhibitor, is Phase 2b-ready for two indications: persistent seizures in Tuberous Sclerosis Complex and severe pain in Trigeminal Neuralgia.

Noema Pharma Announces Completion of Enrollment in the Trigeminal Neuralgia Electronic Diary (TNED) Validation Study

Retrieved on: 
Tuesday, September 6, 2022
Trigeminal nerve, UCL, University College Hospital, Pain, Trigeminal neuralgia, Noema, Sofinnova, Glutamate (neurotransmitter), Seizure, Brain, LIBRA, Sensation, Diagnosis, Self-assessment, Pain scale, Neuropathic pain, GLOBE, Â, Nerve injury, Company, Diary, Tourette syndrome, Data collection, Face, PDE10A, Polaris Partners, CNS, UCLH, Tuberous sclerosis complex tumor suppressors, Patient, Basimglurant, Medical device, Pharmaceutical industry, Research, Biotechnology

BASEL, Switzerland and BOSTON, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces it has completed participant enrollment and data collection in the validation study of a novel Trigeminal Neuralgia Electronic Diary (TNED).

Key Points: 
  • BASEL, Switzerland and BOSTON, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces it has completed participant enrollment and data collection in the validation study of a novel Trigeminal Neuralgia Electronic Diary (TNED).
  • Thirty participants with a confirmed diagnosis of trigeminal neuralgia (TN) volunteered to complete the electronic diary.
  • While the analysis of the validation data is ongoing, the electronic diary was generally found to be easy to use and enabled participants to accurately describe the burden of trigeminal neuralgia (TN).
  • In addition to being patient friendly and easy to use, TNED is the first electronic diary designed specifically for people who suffer from TN.

Noema Pharma Announces Recruitment of First Patient in Orpheus Phase 2b Study of PDE10A Inhibitor gemlapodect in Adults with Childhood Onset Fluency Disorder

Retrieved on: 
Thursday, August 4, 2022
People, Orpheus, Disorder, Tuberous sclerosis complex tumor suppressors, Disability, Glutamate (neurotransmitter), Patient, Stuttering, Company, Neurodevelopmental disorder, CNS, Pain, Safety, FDA, Seizure, Adolescence, Solution, Work, Insulin resistance, GLOBE, PDE10A, Person, Sofinnova, Central nervous system, Â, Neuron, Trigeminal neuralgia, Tourette syndrome, Employment, Ageing, Polaris Partners, Basimglurant, COFD, Population, Pharmaceutical industry, Biotechnology, MD

Orpheus is a multi-center, 11-week prospective, placebo-controlled study to evaluate the safety and efficacy of gemlapodect as monotherapy in adults suffering from COFD.

Key Points: 
  • Orpheus is a multi-center, 11-week prospective, placebo-controlled study to evaluate the safety and efficacy of gemlapodect as monotherapy in adults suffering from COFD.
  • "Recruiting the first participant is an important step in the clinical investigation of gemlapodect in this indication.
  • "Our main goal is to evaluate the safety and efficacy of gemlapodect as a monotherapy for COFD in adults.
  • Gemlapodect, a PDE10A inhibitor, is currently enrolling a Phase 2a clinical trial in patients with Tourette Syndrome.

Noema Pharma Announces FDA Investigational New Drug (IND) Authorization for Orpheus Phase 2b Study of PDE10A Inhibitor Gemlapodect (NOE-105) in Childhood Onset Fluency Disorder

Retrieved on: 
Monday, June 27, 2022
People, Efficiency, FDA, Patient, Sofinnova, Glutamate (neurotransmitter), Basimglurant, Neurodevelopmental disorder, Polaris Partners, TSC, Biology, Investigational New Drug, GLOBE, CNS, Company, Orpheus, PDE10A, Trigeminal neuralgia, Ageing, Disorder, IND, Disability, Neuron, Seizure, COFD, Tuberous sclerosis complex tumor suppressors, US Foods, Tourette syndrome, Safety, Insulin resistance, Work, Pharmaceutical industry, Noema, Biotechnology, Stuttering, Research, MD

The Orpheus Phase 2b study is a multi-center, 11-week prospective, placebo-controlled study to evaluate the safety and efficacy of gemlapodect as monotherapy in adults suffering from COFD.

Key Points: 
  • The Orpheus Phase 2b study is a multi-center, 11-week prospective, placebo-controlled study to evaluate the safety and efficacy of gemlapodect as monotherapy in adults suffering from COFD.
  • "We have great confidence that gemlapodect will help people who stutter maximize their ability to live life to the fullest."
  • Noema Pharma ( www.noemapharma.com ) is a clinical-stage Biotech company targeting debilitating central nervous system (CNS) indications characterized by imbalanced neuronal networks.
  • Gemlapodect, a PDE10A inhibitor, is currently enrolling a Phase 2a clinical trial in patients with Tourette Syndrome.

Pike Therapeutics Announces Positive Pharmacokinetic Animal Study Results and Unexpected Benefits for its Proprietary Weekly CBD Continuous Transdermal Delivery Technology

Retrieved on: 
Tuesday, June 14, 2022
Human, Lennox–Gastaut syndrome, TSC, Seizure, Company, Toxicity, LGS, FDA, GLOBE, Patient, CBD, Tuberous sclerosis complex tumor suppressors, AUC, Tuber, Dravet syndrome, Pharmaceutical industry

VANCOUVER, British Columbia, June 14, 2022 (GLOBE NEWSWIRE) -- Pike Therapeutics Inc., a pre-clinical biotechnology company focusing on transforming synthetic cannabinoids and psychedelics with its proprietary continuous transdermal delivery, has completed a preliminary pharmacokinetic rabbit study with its CBD formulations that yielded positive early results. This study demonstrated that Pike's continuous delivery technology delivered a sustained CBD blood level over 7 days equivalent to oral dosing and achieved an acceptable skin irritation score.

Key Points: 
  • This study demonstrated that Pike's continuous delivery technology delivered a sustained CBD blood level over 7 days equivalent to oral dosing and achieved an acceptable skin irritation score.
  • In humans, this product has a dose to toxicity response which demonstrates that higher exposure is associated with higher toxicity and discontinuance.
  • Pikes objective is to use a dose that is significantly lower and achieve a target blood level that is efficacious.
  • In Pikes animal study we were successful in demonstrating a measurable lowering of exposure.

Noema Pharma to Attend and Present at BioEquity Europe and UBS Global Healthcare Conference in May 2022

Retrieved on: 
Friday, May 6, 2022
EDT, Tourette syndrome, Biotechnology, Sofinnova, GLOBE, CNS, Polaris Partners, Company, Tuberous sclerosis complex tumor suppressors, Trigeminal neuralgia, Patient, Seizure, Glutamate (neurotransmitter), TSC, CEST, PDE10A, Pharmaceutical industry

Presentation on Wednesday 25 May at 1:15 pm EDT / 7:15 pm CEST.

Key Points: 
  • Presentation on Wednesday 25 May at 1:15 pm EDT / 7:15 pm CEST.
  • Noema Pharma ( www.noemapharma.com ) is a Swiss clinical-stage Biotech company targeting debilitating central nervous system (CNS) indications characterized by imbalanced neuronal networks.
  • Noema Pharma was founded with the leading venture capital firm Sofinnova Partners.
  • Investors include Polaris Partners, Gilde Healthcare, Invus and Biomed Partners.