Life science investor Flerie AB (STO:FLERIE) announced on Friday that its portfolio company Bonsai Biotherapeutics has received full approval of its clinical trial application for TOL2 in AChR antibody-positive generalised myasthenia gravis in Sweden and Germany.
This approval enables continued clinical development of the programme.
TOL2 is the company's lead candidate, designed as an antigen-specific tolerogen intended to restore immune tolerance to the acetylcholine receptor and address the underlying disease mechanism. The clinical programme comprises a randomised, double-blind, placebo-controlled Phase 1b/2a study assessing safety, tolerability, and preliminary efficacy across single- and multiple-ascending dose cohorts.
Flerie AB holds 100% ownership of Bonsai Biotherapeutics.
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