Cybin, Bright Minds And PharmAla: A Short Recap On Progress Within Clinical Trials

Cybin One Steps Away From Complete Dosing

Cybin CYBN completed dosing on five of six participant cohorts in its ongoing Phase 2 trial evaluating proprietary deuterated psilocybin analog CYB003 for the treatment of Major Depressive Disorder (MDD).

Much like cohort 4, cohort 5 was administered the psychedelic in two doses of 12 milligrams each, with no reported serious adverse events that may forestall continued dosing. 

CEO Doug Drysdale says the dosing completion brings the company closer to establishing “a therapeutically efficacious dose” as well as advancing CYB003 toward FDA-approved pivotal studies as “a differentiated and rapid-acting therapeutic option for people with MDD." 

See Also: Cybin's FY2023 Financials, Guidance And Appointment Of Sanford R. Climan As Strategic Advisor

To date, CYB003 showed a favorable safety and tolerability profile at 1 milligrams, 3 milligrams, 8 milligrams, 10 milligrams, and 12 milligrams, as assessed through the Phase 1/2a study.

Interim findings indicate that low doses of the psychedelic led to a reportedly “rapid and robust” psychedelic response.

The team is now recruiting for cohort 6, the final one in the Phase 2 portion of the study. It expects to deliver topline efficacy data before the end of the year, after which Cybin would apply to the FDA to commence pivotal studies.

Bright Minds Biosciences: Positive Clinical Data

Bright Minds Biosciences DRUG has completed its three-part Phase 1 clinical trial of BMB-101, a novel “highly selective and potent” 5-HT2C agonist in development for the treatment of refractory epilepsies, psychosis, addiction and impulse control disorders.

The study, conducted in Australia, evaluated the safety, tolerability, pharmacokinetic (PK) and food effect in healthy volunteers. Topline results show BMB-101 holds an “excellent” safety and tolerability profile. The 5-HT2C target engagement was demonstrated by transient, dose-dependent increases in prolactin, and the current formulation allows for two daily oral doses. 

Bright Minds believes moderate doses of BMB-101 will fully engage 5-HT2C receptors, and therefore not be dose-limited by side effects. This would help achieve maximal efficacy in Phase 2 studies, considering first generation 5-HT2C agonists dose-limited side effects have “prevented exploiting the full potential of this pharmacological mechanism.”

CMO Mark Smith says the study observations "give us confidence in selecting doses of BMB-101 for testing in refractory epilepsies and other disorders where serotonin 2C agonists are indicated.” 

5-HT2C agonism is a reportedly well-proven anticonvulsant mechanism. In animal models, BMB-101 demonstrated a “significant reduction” in both the number and intensity of epileptic seizures, and is a promising candidate for the treatment of Dravet Syndrome and other epilepsies. 

The company is currently awaiting the qEEG (Quantitative Electroencephalogram) data, after which it would provide a more detailed discussion of the results.

PharmAla Gets MHRA Guidance On ALA-002, Launches Clinical Program With Australian Univ.

PharmAla Biotech Holdings PMBHF has received written guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which includes advice that MDMA analog ALA-002 does not require further preclinical data to proceed to clinical trials.

PharmAla’s Research VP Dr. Harpreet Kaur says the result conforms with the team’s expectations. 

“We are now prepared to move into the clinical phase of ALA-002’s development with full confidence that we have a range of competent and well-regulated jurisdictions to choose from,” Kaur stated. “Our intent is to move rapidly, with the expectation of moving into a Phase 2 trial.”

CEO Nick Kadysh says ALA-002 represents one of PharmAla’s most promising IP assets.

“Not only is it viable as a treatment for fear disorders –much like generic MDMA– but with its improved toxicology, we are hopeful that clinical trials will bear out its viability for treating another orphan indication. PharmAla intends to treat the symptoms of social anxiety in Autism patients,” he added.

Following the guidance’s receipt, PharmAla announced it has entered into a clinical development agreement with the University of Sydney under the leadership of chair in child and youth mental health Dr. Adam Guastella.

See Also: PharmAla's Australian JV Cortexa Orders First Commercial MDMA & Psilocybin Shipment

Photo: Benzinga edit with photo by aiyoshi597, Gisele Yashar, Bacsica and Gorodenkoff on Shutterstock.