Acer Snags First-Ever FDA Approval With Relief-Partnered Olpruva

Massachussetts-based Acer Therapeutics announced a huge milestone for the company with the FDA’s approval of its Relief Therapeutics-partnered urea cycle disorders (UCD) therapy, Olpruva. The approval marks the first-ever FDA-approved drug for Acer and could unlock a $42.5 million loan for the company, extending its financial runway into the second half of next year.

Big News for a Budding Biotech Company

Acer developed Olpruva alongside Relief to treat certain patients with UCD involving carbamyl phosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase deficiencies. UCD is a group of rare genetic disorders that can cause ammonia buildup in the blood. If too much ammonia builds up, patients can develop brain damage and neurocognitive impairments. 

Olpruva is an oral suspension designed to treat UCD with certain therapy and changes in diet. The FDA approved the drug for adults and children weighing over 44 pounds or a greater body surface area than 1.2 square meters. 

CEO and founder of Acer, Chris Schelling, said, “This approval represents the first FDA-approved product for Acer, validating our ability to identify and develop treatments where science can be applied in novel ways and make them available to patients as quickly and efficiently as possible. In addition, this approval unlocks our Marathon debt funding option and provides us with resources to advance our pipeline of investigational product candidates.”

In tandem with the approval, Acer has the opportunity to unlock a $42.5 million loan established with Marathon Asset Management L.P. in March this year. If Acer draws the funding, it said the loan would extend the company’s financial runway into the second half of 2023. 

Apart from Olpruva, Acer is developing therapies for vasomotor symptoms, acute stress and PTSD, and Vascular Ehlers-Danlos Syndrome (EDS). Edsivo, Acer’s EDS therapy candidate, is currently in Phase 3 clinical trials.

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Another Option for UCD Patients

Olpruva’s approval adds it to a list of previously approved therapies to treat UCD, making it another valuable option for patients with various needs. The most notable available UCD therapies include Buphenyl and Ravicti. 

Approved in 1996, Buphenyl quickly became the gold standard for UCD therapies. Since then, several companies have developed FDA-approved generic versions of the drug. Acer used Buphenyl data to support Olpruva’s Biologics License Application and included studies comparing Olpruva to Buphenyl.

Ravicti, another UCD therapy, is commonly used to treat the disorder. Though Acer and Relief have not yet released pricing models for Olpruva, Relief expects to price Olpruva significantly lower than Ravicti.

The FDA’s decision to approve Olpruva provides UCD patients with another treatment option that may better suit their needs. The approval marks Acer’s first approved product and provides the company access to a $42.5 million loan to allow it to keep developing therapies for rare diseases. 

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Author

Reed Slater