Unravel Announces Initiation of RVL001 Clinical Trial Material Manufacturing to Support Upcoming US and International Clinical Trials in Rett Syndrome

Manufacturing of GMP material for clinical trials represents key step towards initiation of clinical studies.

BOSTON, March 19, 2024 /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), an AI-enabled therapeutics company established to advance drugs for complex diseases, today announced a manufacturing and development partnership with Quality Chemical Laboratories, Inc. (QCL) to manufacture RVL001 clinical trial material for use in upcoming Rett syndrome clinical trials in the US and Colombia. The collaboration with QCL is part of a broader strategy to secure the GMP manufacturing and supply chain of key proprietary technology owned by Unravel.

Rett syndrome is a rare neurogenetic disorder leading to debilitating cognitive, motor and autonomic disability. With a global incidence of one in 10,000 female births, Rett syndrome represents an orphan disease with widespread impact and only one FDA-approved treatment. Unravel's proprietary drug discovery platform identified RVL001 as a promising therapeutic for Rett syndrome, as well as RVL002, a novel small molecule currently being developed. RVL001 will be tested in the US and in Colombia in proof-of-concept clinical trials as a key path to effective Rett syndrome treatment.

"We are pleased to announce yet another key milestone in our RVL001 clinical development program," said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "The initiation of manufacturing clinical trial material is a key remaining step to initiating clinical testing in our global Rett syndrome RVL001 trials."

"QCL is pleased to leverage its strong synthetic and analytical chemistry expertise to help Unravel move the RVL001 program into the clinic," said Dr. Yousry Sayed, President and CEO of QCL. "Our capabilities will allow Unravel to efficiently initiate their clinical trial programs in the US and overseas with a rapid scale up as needed of clinical and commercial supply as the program advances."

About Unravel

Unravel Biosciences is the first rapid prototyping therapeutics company, integrating AI systems biology computation with rapid in vivo screening and clinical validation of discovered targets with unprecedented efficiency. Unravel leverages its proprietary BioNAV^™ platform combining target and drug discovery, preclinical screening and patient stratification to find treatments for complex diseases. Unravel's platform has led to four clinical trials starting in 2024, developed RVL002, a first-in-class new molecule targeting mitochondrial metabolism, and discovered RVL027, a molecule targeting a novel mechanism to treat dystonias. The rareSHIFT^™ program provides platform access to accelerate and clinically derisk therapeutics. www.unravel.bio and www.rareshift.org.

SOURCE Unravel Biosciences, Inc.