Bright Minds Biosciences Inc. announced the initiation of its Prader-Willi Syndrome (PWS) program, and nomination of BMB-105 as a new clinical candidate. As part of the development program, Bright Minds will commence: A Phase 2a (NOVA) study to assess the efficacy, safety and tolerability of BMB-101 for the treatment of patients with PWS. This study is designed as a proof-of-pharmacology study to demonstrate that 5-HT2C agonists will address symptom complex in PWS patients.
A randomized Phase 1 placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and food effect of BMB-105 in healthy volunteers. Following completion of the ongoing Phase 2a proof-of-pharmacologists study with BMB-101, Bright Minds plans to select and advance a 5-HT2C molecule (BMB-105) as the dedicated compound for the PWS program. This approach will reduce the time to market by approximately one year.
Ms. Roof also works with residential and clinical professionals and schools to provide best practices for those living with PWS and WS. She has managed five NIH trials and 11 clinical trials in PWS since 2014 and works with sponsors to identify best outcome measures, study designs, and logistics that best suit PWS families. Ms. Roof has spoken at PWS and was conferences across the US, Canada, Europe, and Australia.
Members of Bright Minds' leadership team will provide an update and status of the ongoing clinical study in epilepsy. The team will also review the therapeutic rationale for the proprietary 5-HT 2C agonists in PWS and discuss the Company's study to assess efficacy, safety and tolerability the BMB-101 for thetreatment of patients with PWS. The NOVA clinical study is a double-blind, randomized, Phase 2a study lasting up to 16 weeks.
There will be a 4-week screening period, during which hyperphagia and PWS-related behavioral testing will establish the presence and degree of PWS symptoms. Primary Endpoint: Hyperphagia. Change from Baseline in Hyperphagia Questionnaire for clinical trials (HQ-CT) scores over time. Secondary Endpoints: Hyperphagia.
There are no drugs that can adequately address those issues. BMB-101 is a novel scaffold 5-HT2C Gq-protein unbiased agonist developed using structure-based drug design. In Phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and food-effects study.
Bright Minds has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. Forward-looking statements in this news release include statements related to the initiation of the PWS program, the selection and advancement of a 5-HT2C molecules (BMB-105) As the dedicated compound for the PWP program, the initiation of the NOVA compound for the PWS program, the completion of the NOVA study, the initiation of the NO VA study is a double-blind and clinical study. Bright Minds has develop a unique platform of highly selective Serotonergic agonists exhibiting selectability at different serotonergic receptors".
