Panel takes on challenges in pain therapeutics at BIO CEO

opioids

Panel takes on challenges in pain therapeutics at BIO CEO

Published: Feb 09, 2023

By Lisa Munger

BioSpace

Finding long-term, non-addictive solutions to manage chronic pain in the U.S. has long been a challenge for biopharma. In the fallout from the opioid pandemic, physicians and researchers are scrambling for options.

Tuesday, a panel of experts took on stiff questions about pain/addiction therapeutics during a panel hosted by the Biotechnology Innovation Organizaion (BIO) in New York City.

The rub for the panelists (and patients) is the addiction stigma. No one wants to invest in “addicts,” though they may be an outcome of the opioid industry and overzealous physicians.

It comes down to money in many respects.

David Thomas, vice president of industry research at BIO, the report’s cowriter and a panelist, told BioSpace:

“One of the points about efficacy and success rates is that in the success rates, we account for a failure, a financial failure. So, it’s important to remember that for some of those companies, it wasn’t necessarily because of efficacy,” he said.

“They’re just not getting the financing. That’s actually one of the big problems right now; you might have a promising drug that just needs that extra funding to get that extra patient enrolled in Phase II for proof of concept.”

Cut to the compelling Netflix specials on the Opioid Epidemic.

“Dopesick” and other documentaries have made the public a bit more aware of the machine the chronic pain population faces.

Heavy on the patient total; light on next steps.

Patient Population

Within this is a common and stigmatized zeitgeist regarding the addicted population, as opposed to non-addicted chronic pain sufferers. The panel addressed the issues head-on, with contemplative reflection and a determination to seek venture capital to serve their populations.

“One big challenge that we are facing is how poorly predictive the preclinical data has typically been of clinical success,” Thomas said. “One approach that we’re taking is looking at better-humanized models or human tissue models, human samples that we can study at the preclinical stage to potentially improve success at the later clinical stages.”

A new study from BIO found that 77% of clinical drug treatment programs active in 2017 are no longer active today.

Why is this?

BIO listed the following factors in its most recent white paper:

  • “The number of active clinical drug programs for pain has plummeted from 220 in 2017 to 124, a 44% decrease. While addiction programs increased, they remained low at 39.
  • And for drugs in trials, chances of approval are slim— .7% of novel pain drugs entering clinical trials reach final approval by the FDA, compared to 6.5% across all disease areas.
  • More investment is needed: 1.3% of total therapeutic venture capital investment went to pain and addiction companies in 2021.”

How to Find New, Non-addictive Therapeutics

For Hernan Bazan, M.D., CEO and co-founder of pain therapeutics-focused South Rampart Pharma, finding non-addictive solutions to chronic pain is challenging, particularly when up against a 75% failure rate.

It affects much-needed venture capitalists and their willingness to invest in the space.

“When investors see attrition rates like that, they get scared,” Bazan told BioSpace. “We appreciate investors willing to buck the trend and help us pioneer best-in-class medicines such as ours, SRP-001.”

Fellow panelist Diem Nguyen, CEO of Xalud Therapetucs, underscored Bazan’s point.

“The nature is to [create] a clinical trial study that’s controlled but doesn’t reflect [what] real life is,” she said. “This is one of the fundamental challenges that translate from preclinical to clinical. This is where drug manufacturers, regulatory bodies and basic science need to rally together and think about the totality of the evidence.” 

Source: BioSpace