Cybin Announces Completion of FDA Type B Initial Breakthrough Therapy Meeting and Plans for CYB003 Phase 3 Program in Major Depressive Disorder
- Company expects to initiate Phase 3 pivotal trial in late summer 2024 -
- Phase 3 pivotal study to include 30 clinical sites across
- Pivotal trial designs incorporate elements to address functional unblinding -
- Company to report 12-month Phase 2 efficacy data for CYB003 in Major Depressive Disorder (“MDD”) in Q4 2024 -
“Following our productive Type B meeting, we continue to expect to commence our Phase 3 pivotal program in late summer,” said
Further to recent industry discussions around the subject of functional unblinding, the Company plans to implement multiple measures to attempt to mitigate the risk of functional unblinding in its pivotal study program, as follows:
- The pivotal study program will include one study with a three-arm design with a high dose, mid-dose, and placebo arm. Patients will not know if they received the therapeutic high dose or the sub therapeutic mid-dose, mitigating the unblinding to an extent and addressing potential expectancy bias;
- The study will utilize remote, independent, blinded raters who will not have any information on the dose received or the participant’s dosing experience;
- The reporting of effects during the dosing session will be firewalled to ensure that the study team stays blinded;
- The studies will recruit participants who are largely psychedelic naïve to reduce the impact of expectancy bias;
- The studies will assess long-term efficacy data points up to one year, to outlast any potential expectancy effects.
In addition, the study will include manual and real time artificial intelligence screening of monitoring sessions to ensure monitor fidelity and patient safety.
The Company also today announced the realignment of the composition of its
About
Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens.
Headquartered in
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plans to progress to a Phase 3 trial of CYB003 in late summer 2024; the release of 12-month durability data from Phase 2 study of CYB003 in Q4 2024; commencing enrollment at 30 clinical sites across the
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended
Neither the Cboe Canada, nor the
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