BIO urges more VC, R&D in neglected areas, starting with depression

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Only 29 active substances have been FDA-approved for major depression since 1959, and all of them work the same way—by modulating the brain’s monoamine neurotransmitter levels.

Over the years, the Biotechnology Innovation Organization (BIO) has noticed a slide in venture funding for some “highly prevalent, chronic diseases.” Now, BIO is releasing a series of reports calling for more work to be done in certain disease areas, starting with depression.

While the situation isn’t yet dire, BIO wants to turn this trend around before it leads to a dearth of new drugs in areas, such as diabetes, psychiatric disorders, and cardiovascular and respiratory diseases. Venture investment in such areas has been dropping over the last decade relative to the prevalence and healthcare cost of these diseases, David Thomas and Chad Wessel said in the BIO report.

With the series, BIO aims to identify and surmount “barriers to therapeutic innovation.”

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In the case of depression, alarm bells are ringing. Only 29 active substances have been FDA-approved for major depression since 1959, and all of them work the same way—by modulating the brain’s monoamine neurotransmitter levels, including serotonin levels.

As for new approaches outside of monoamine regulation, many of these programs have run into roadblocks, with some being redesigned a second or third time, with others being dumped entirely, BIO said.

There are currently 33 drug programs with new targets in clinical trials, with clinical trial initiations down 50% over the last decade, according to the report. More worrisome, drug candidates for new studies are “nearly non-existent.”

The end of 2017 saw some promise in the space, with Sage Therapeutics’ candidate eliciting near-immediate, durable improvements in a phase 2 trial of patients with major depressive disorder (MDD), and Alkermes filing a rolling FDA application for its antidepressant, ALKS 5461. While the drug had two inconclusive phase 3 studies, the drug, a combination of samidorphan and buprenorphine, uses a novel mechanism to treat MDD.

San Francisco-based BlackThorn is taking a hybrid biotech-medtech approach to depression and other neurobehavioral disorders. The company seeks to use functional imaging and objective assessment tools to quantify behavior, emotion and cognition to better define disorders and create more targeted drugs.

“What makes BlackThorn unique, unlike what has historically been done here by large pharma companies (which have largely targeted neurotransmitters), is that BlackThorn is specifically focused on key neuropeptides that are regulating known targets and circuits linked to the behaviors that are needing to be regulated,” CEO Charles Gregory Vontz said.