Baltimore-based Cerecor has a fast-tracked, fast-acting drug called CER-301 that treats those with severe major depressive disorder and suicidal tendencies. And it works a little like ketamine, the anesthetic-turned-illicit party drug-turned-psychiatric therapy du jour.
The company just raised a $16 million tranche in a $32 million Series B round to fund ongoing Phase 2 trials for the medication. It also plans to use the funding to expand on its Catechol-O-Methytransferase platform, to focus on drugs that sharpen memory and executive function. The financing was led by New Enterprise Associates, Apple Tree Partners and MPM Capital.
It’s still very difficult to treat severe depression – current meds take a long while to kick in, if at all, and the side effects can be pretty unpleasant. There’s an unmet need for a fast-acting treatment for this disorder, and one under trial is ketamine, or “Special K” to the rave subset. Administered intravenously in sporadic doses by physicians, the drug has been found to elevate mood over a sustained period of time. But it’s considered a “dirty drug,” with somewhat unpredictable outcomes.
Cerecor’s compound improves upon ketamine’s shown efficacy, CEO Blake Paterson said, working on the NMDA pathways in a similar manner – but with an improved safety profile.
“We want to see if we can reproduce the ketamine high, and see what the impact is on mood and blood pressure,” Paterson said. “And unlike ketamine, CER-301 is clean – it doesn’t tweak.”
Cerecor’s drug in development can be taken orally and once a day for more consistent therapy. It is conducting an “important safety study with extremely high doses of CER-301,” and will soon transition into a dose-ranging study. The current 135-patient study is expected to produce results by the end of the year.
CER-301 was initially being developed by Merck, but the pharma giant dropped the compound due to internal restructuring and Cerecor licensed rights to the compound last year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Cerecor is also directing the new funding toward its catechol-O-methyltransferase (COMT) inhibitor platform, which could treat “various conditions characterized by impairment of executive function and working memory.” It plans to identify a second lead compound under the COMT platform by the end of the year.
There are a number of conditions – such as Parkinson’s disease and schizophrenia – that require extensive meds to keep in check. But in the process, the side effects can cause a patient to slow down in cognition and memory. The COMT platform is aimed at helping “sharpen” the minds of people who have lowered dopamine levels in the prefrontal cortex, Paterson said. Other conditions that could benefit from this class of drugs include Tourette’s syndrome, a number of addictions and impulse control behaviors including gambling, and ADHD.
