Formation Bio Doses First Participant in Phase 1 Trial of BLKR201, a CNS-Penetrant TYK2 Inhibitor

Company advances molecule from deal close to Phase 1 five months after in-licensing the asset

NEW YORK, June 9, 2026 /PRNewswire/ -- Formation Bio, an AI-native pharma company, today announced dosing of the first participant in a Phase 1, first-in-human (FIH) clinical trial of BLKR201. The study, BLKR201-101-HV, is a single ascending dose (SAD) and multiple ascending dose (MAD) trial in healthy volunteers.

"BLKR201 is an example of how Formation Bio's AI-native development model can expand what is possible for promising medicines," said Benjamine Liu, CEO and Co-Founder of Formation Bio. "By combining deep domain expertise with AI tools purpose built for accelerating drug development - across indication strategy, evidence generation, and trial execution - we were able to rapidly evaluate BLKR201's biology, identify novel development opportunities and indications where its CNS-penetrant and selective TYK2 profile could be most meaningful, and move from deal close to first participant dosed in five months. For partners like Lynk Pharmaceuticals — and for our future partners with high-potential assets — our platform is designed to help start the right trials faster and increase the probability that important medicines reach the patients who need them."

BLKR201 is an investigational next-generation, CNS-penetrant allosteric TYK2 inhibitor designed to regulate immune signaling within the central nervous system. While TYK2 is a validated target with an established clinical safety profile, the CNS exposure and high target selectivity of BLKR201 may open up indications where central or compartmentalized immune pathways are believed to drive disease — including a range of autoimmune and inflammatory conditions. BLKR201 is an investigational compound that has not been approved by the FDA and the BLKR201-101-HV study marks the first time the molecule has been evaluated in humans. A data readout is expected in early 2027.

BLKR201 was originally licensed from Lynk Pharmaceuticals in December 2025 and is being developed through Formation Bio's subsidiary Bleecker Bio. "Through our hub-and-spoke model, every asset benefits both from the power of our core in-house development expertise as well as the dedicated attention of a focused team, plugged into Formation Bio's AI ecosystem at every point of development. That combination is what makes this kind of swift development progress possible," said Michael Dunn, General Manager, Bleecker Bio.

About Formation Bio
Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients.

About Lynk Pharmaceuticals

Lynk Pharmaceuticals is a clinical-stage innovative drug company focused on autoimmune and inflammatory diseases, committed to addressing unmet clinical needs through first-in-class innovation, developing differentiated small-molecule therapies, and providing superior oral alternatives to biologics. The company was founded by senior R&D leaders from Pfizer, MSD, and Johnson & Johnson, focusing on the JAK-STAT and expanding to TYK2 signaling pathways, and mastering targeted protein degradation.

This press release contains forward-looking statements regarding Formation Bio's clinical development programs, including the BLKR201-101-HV trial and anticipated data readout. These statements involve known and unknown risks and uncertainties, and actual results may differ.

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SOURCE Formation Bio