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Treatment of depression is awaiting innovation, and although there are many drugs in the biopharmaceutical pipeline, several failures have prevented a breakthrough in the field for many years.
As of January 2023, 163 drug candidates According to PhRMA, industry-wide approvals for psychiatric disorders total 100, and for depression 54. Despite these numerous applications, success has been slow.
For example, Sage Therapeutics and Biogen’s depression treatment Zurzuvaeis not approved to treat major depressive disorder, the most common form of depression, but only postpartum depression. Passed by Over the past 20 years, despite the unmet need for many disorders, depression has accounted for approximately 280 million Around the world, according to the WHO.
Among the biopharmaceutical companies working hard to find new treatments for depression is Autobahn Therapeutics, a San Diego-based biotech company with one drug candidate. At the clinic It is investigating both MDD and bipolar depression, and its lead candidate, ABX-002, is a selective thyroid hormone beta-receptor agonist that is entering Phase 2 clinical trials for both indications.
Since its founding in 2020, Autobahn has raised significant funding. Last month, the company closed a $100 million Series C funding round from big-name investors including Biogen, Bristol-Myers Squibb and Pfizer Ventures. Prior to the Series C, Autobahn raised $125 million from the same big pharma and venture capital investors. Autobahn also Notable BiotechsAn IPO may be on the horizon. The company’s capital raise underscores the interest that big pharmaceutical companies have in pursuing solutions for MDD.
The company said the new funding will enable Autobahn to advance into Phase 2 clinical trials. We spoke with Kevin Finney, president and CEO of Autobahn, in an email interview to learn how the company managed to secure a prominent investor at a time when the biotech investment market is recovering from years of stagnant growth.
PHARMAVOICE: How does ABX-002 fit into the mix of medications already being used for MDD and bipolar depression? What makes ABX-002 different?
Kevin Finney: One of the primary factors behind the unmet need for MDD and bipolar depression is the lack of safe, well-tolerated treatments that provide clinically meaningful benefit to patients. More than half of patients with depression do not respond adequately to selective serotonin reuptake inhibitors. These treatments are associated with troublesome side effects that fail to address the very common symptoms of depression, forcing patients to discontinue treatment.
The brain’s bioenergetic mechanisms underlying ABX-002 are believed to be uniquely positioned to treat a highly prevalent subgroup of atypical depression, which accounts for up to 35% of patients with MDD and up to 50% of patients with bipolar depression and for which there are currently no approved treatments.
Our Phase 1 study demonstrated that ABX-002 was safe and well-tolerated in healthy volunteers, supporting a potential profile without major side effects, including weight gain, sexual dysfunction, dissociation and somnolence.
What is the market potential for ABX-002?
“In the United States, there are more than 21 million people living with MDD and approximately 7 million people living with bipolar depression. Despite significant concerns about tolerability and limited efficacy, several approved treatments currently generate more than $1 billion in annual revenue as adjunctive treatments for depression. We believe that ABX-002’s target profile has the potential to achieve similar commercial success given the significant need that could be met across MDD, bipolar depression and atypical depression subgroups.”
What are your thoughts on the current biotech investment space?
It’s no secret that the capital market environment over the past few years has been challenging for biotechnology companies of all shapes and sizes. Despite these headwinds, investors looking to build companies continue to back stories with strong biology and clinical evidence in areas with unmet need and a clear path to value conversion. We are very fortunate to have the backing of such investors, and immediately upon closing this Series C, we are focused on executing on our clinical strategy funded by this financing.
Neurology has been disappointing in recent years with several failed drug approvals. How do you convince investors in early clinical stages in this environment?
Investors quickly understood the vast unmet need that exists in neuropsychiatry. As such, many investors are actively backing companies in the MDD and bipolar depression space and sought to understand the steps we had taken to de-risk ABX-002’s development path, including preclinical pharmacology characterization and Phase 1 safety data in healthy volunteers, to name just a few. Investors were also interested in understanding how we were thinking about de-risking Phase 2 clinical trials in MDD and bipolar depression, from the study design, to the endpoints being used, to the nature of the patient population being studied. Finally, we sought to educate investors on the data and rationale supporting each of our development decisions to increase the odds of success in future clinical trials.
