Bright Mind Shares Surge 91% After Reporting Positive EEG Clinical Results Of Next-Gen Compound

After Bright Minds Bioscience's DRUG announcement that its quantitative EEG garnered positive results, the company stock shot up 91% Tuesday morning,  spiking to $6.18 from Monday's close of $3.23 per share.

The recently-completed three-part Phase 1 study had shown positive topline data regarding BMB-101's “excellent” safety and tolerability profile in both single and multiple ascending doses as well as regarding food effects, and the compound’s “demonstrated central target engagement and predictable plasma pharmacokinetics.”

In this latest qEEG study, the novel “highly selective and potent” 5-HT2C agonist for the potential treatment of refractory epilepsies, psychosis, addiction and impulse control disorders showed:

• Proof of mechanism and central target engagement in the brain, as established using blood biomarkers and qEEG;

• A “robust increase” in central delta power and “robust reduction” in central alpha and beta power in active groups, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals;

• Increased gamma frontal parietal connectivity in the treatment group, an improved AED principle over benzodiazepine (GABA receptor) AED drugs; and

• Power and connectivity changes were concentration-dependent.

CEO Ian McDonald says both data sets together validate Bright Minds’ approach. “BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT2C mechanism.” 

With Phase 1’s completion, the company says BMB-101 is now “a Phase 2-ready asset” and will accordingly apply with the FDA to advance in that direction.

CSO Jan Torleif Pedersen says the team is especially pleased that BMB-101 has demonstrated central target engagement by transient prolactin increase and qEEG changes, and believes the compound “has the potential to be a best-in-class, novel pharmacophore 5-HT2C agonist for the treatment of seizure disorders” and other applications where serotonin 2C agonists could be useful.

The company will host a webcast to discuss the results this afternoon at 4:30 PM ET.

The Recording And Full Study Context

During the EEG recording, Bright Minds stated participants were seated with an FDA-approved 19 electrode EEG headset provided by Zeto Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording. 

The EEG recording time was 10 minutes (~5 minutes resting with eyes closed and ~5 minutes resting with eyes open), with four recording timepoints: day 1 immediate pre-dose and 1h post-dose, and day 7 pre- and post-dose. Data were analyzed via FireFly Neuroscience’s analysis platform.

This Phase 1 study’s part 1 assessed BMB-101 in a single-ascending, oral solution dose in four cohorts (6 drug and 2 placebo), reached the planned top dose of 180 mg/70 kg and it proved to be well tolerated with predictable PK (most common adverse event was oral paresthesias from liquid formulation.)

Part 2 investigated food effect on 12 subjects via a crossover with and without breakfast (120 mg/70kg,) results showing BMB-101 can be administered without the need for fasting.

Final part 3 tested BMB-101 in a multiple-ascending dose in four cohorts (6 drug and 2 placebo,) specifically two daily doses for seven days after meals. Top dose reached was of 150 mg/70 kg twice a day.

Photo: Benzinga edit with photo by Zita and canadastock on Shutterstock.