by bloomscience | Jan 4, 2023 | Press Releases
SAN DIEGO, Calif., January 4, 2023 — Dr. Stephen Wright joins Bloom Science, Inc., a clinical-stage biotechnology company developing novel medicines for neurological diseases and conditions, as a senior scientific and medical advisor alongside clinical advisors Jacqueline French, MD and Eric Kossoff, MD. The clinical advisory board provides guidance on Bloom’s discovery, development, and commercialization of new generation medicines – live biotherapeutic products (LBPs) – to treat neurological diseases.
Dr. Wright brings to Bloom over 30 years of biotech and pharmaceutical expertise developing medicines, including: Epidiolex, a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients one year of age and older; and approval of the first second-generation 5 lipoxygenase inhibitor.
He served as chief medical officer and an executive member of the main board of directors of GW Pharmaceuticals from 2005 to 2018. He joined GW from Ispen, where he was senior vice president of clinical research and development and a member of the UK board of directors. Dr. Wright also served as venture head of neuroscience at Abbott Laboratories. He has numerous higher degrees and has authored over 100 publications. Dr. Wright is a visiting professor in the School of Chemistry, Food, and Pharmacy at The University of Reading.
“Bloom is thrilled to receive Dr. Stephen Wright’s innovative medical expertise as a member of our respected clinical advisory board as we advance our lead program to develop an orally-administered LBP to treat Dravet syndrome and other epileptic diseases,” said Christopher Reyes, PhD, CEO, founder, and director of Bloom Science.
Bloom clinical advisory board member Dr. French serves as chief scientific officer of the Epilepsy Foundation. She is also a professor of neurology in the Epilepsy Section at the New York University Langone Medical Center. Dr. French also serves as director of the Epilepsy Study Consortium, a nonprofit organization devoted to speeding new therapies through the development process and into the clinic.
Bloom medical advisor Dr. Kossoff is director of the Child Neurology Residency Program and a professor of neurology at Johns Hopkins Medicine. His expertise and research is in seizures and epilepsy, Ketogenic diet and Atkins diet for children and adults, infantile spasms, and Sturge-Weber syndrome.
ABOUT BLOOM SCIENCE
Bloom Science is a clinical-stage biotechnology company on a mission to bring transformative live biotherapeutic products (LBPs) to underserved patients with rare or complex neurological diseases who have not adequately responded to existing therapies. Bloom is taking a fundamentally different path to developing medicines by harnessing our expanding insight into how the gut microbiome modulates key processes in the immune system, nervous system and brain. Bloom has developed a platform to investigate how changes in the gut microbiome influence brain biochemistry and immune system activity that it can leverage to develop multi-functional therapeutics addressing multi-pathway driven neurological disorders. Learn more: https://bloomscience.com/
by bloomscience | Jan 4, 2023 | Press Releases
SAN DIEGO, Calif., January 4, 2023 — Bloom Science, Inc., a clinical-stage biotechnology company developing novel medicines for neurological diseases and conditions, and Yeda Research and Development Co Ltd, the Weizmann Institute of Science’s technology transfer arm to advance science for the benefit of humanity, have entered into an agreement in which Bloom obtained from Yeda an exclusive, worldwide license to use specific microbial strains in developing and commercializing live biotherapeutic products (LBPs) to ameliorate amyotrophic lateral sclerosis (ALS) symptoms.
There is a large unmet need for patients who have not responded to existing therapies for ALS, a disease that causes nerve cells to die, which breaks the neural pathways, and causes extreme mobility loss over time. Bloom’s systematic approach to developing a new generation of therapeutics starts with the gut microbiome.
“The gut microbiome’s influence on the brain offers incredible potential for healing,” said Bloom Science founder and CEO Christopher Reyes, PhD. “Bloom’s collaboration with Yeda enables us to advance our program to modulate the gut microbiome interaction with the brain and provide ALS patients with new therapeutic options that help restore brain function.”
Bloom’s final lead orally-administered LBP candidate selection for ALS, BL-002, started in 2022 with animal models and will advance towards human clinical trials in 2023. The company is testing multiple drug candidates for ALS.
Bloom’s BL-002 is built on evidence that oxidative stress drives ALS by causing the loss of motor neurons and the dysfunction of mitochondria. Nicotinamide, an important NAD+ pathway metabolite and a derivative of vitamin B3, can counter the effects of ALS.
BL-002 produces this vitamin and Bloom has shown it attenuates motor-neuron loss, and increases lifespan and motor coordination, in ALS model mice.
ABOUT BLOOM SCIENCE
Bloom Science is a clinical-stage biotechnology company on a mission to bring transformative live biotherapeutic products (LBPs) to underserved patients with rare or complex neurological diseases who have not adequately responded to existing therapies. Bloom is taking a fundamentally different path to developing medicines by harnessing our expanding insight into how the gut microbiome modulates key processes in the immune system, nervous system and brain. Bloom has developed a platform to investigate how changes in the gut microbiome influence brain biochemistry and immune system activity that it can leverage to develop multi-functional therapeutics addressing multi-pathway driven neurological disorders. Learn more: https://bloomscience.com/
by bloomscience | Jan 4, 2023 | Press Releases
SAN DIEGO, Calif., January 4, 2023 — Bloom Science, Inc., a clinical-stage biotechnology company developing novel medicines for neurological diseases and conditions, successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) and gained alignment on the initial Phase 1 clinical trial of its oral, live biotherapeutic product (LBP), BL-001, for the treatment of patients with Dravet syndrome.
Dravet syndrome is a developmental and epileptic encephalopathy, a severe form of epilepsy with frequent and difficult to treat seizures that begin in infancy or early childhood and causes developmental challenges. Bloom’s BL-001 LBP is reverse translated from positive clinical outcomes associated with the ketogenic diet in treating refractory epilepsy.
Bloom presented to the FDA its planned Phase 1 study design, including the proposed patient population. The FDA aligned with the source and characterization of Bloom’s product strains, provided patient criteria guidance and agreed that no additional nonclinical studies are required to initiate the Phase 1 study in healthy volunteers.
BL-001 is set to enter the clinic, with a phase 1 clinical trial in early 2023.
ABOUT BLOOM SCIENCE
Bloom Science is a clinical-stage biotechnology company on a mission to bring transformative live biotherapeutic products (LBPs) to underserved patients with rare or complex neurological diseases who have not adequately responded to existing therapies. Bloom is taking a fundamentally different path to developing medicines by harnessing our expanding insight into how the gut microbiome modulates key processes in the immune system, nervous system and brain. Bloom has developed a platform to investigate how changes in the gut microbiome influence brain biochemistry and immune system activity that it can leverage to develop multi-functional therapeutics addressing multi-pathway driven neurological disorders. Learn more: https://bloomscience.com/
