ABCV Biopharma brings together plant-based active ingredients against cancer, MDD and ADHD

Botanical medicines – plants – formed the bulwark medicine since time immemorial, but took precedence over faster-acting and more robust synthesized compounds in the late 19th and 20th centuries. However, medicinal plants are still used by much of the world and are the basis for many new and emerging therapies.

ABVC Biopharma, based in California, has phase II trial programs to treat major depressive disorder (MDD), attention deficit hyperactivity disorder (ADHD) and myelodysplastic syndrome (MDS) using ingredients herbal active ingredients derived from traditional Chinese medicines. BioSpace sat down with ABVC Biopharma CEO Howard Doong, MD, Ph.D., to discuss the company’s work in plants.

BioSpace (BSp): Why are botanical plants experiencing a resurgence of interest?

Howard Doong (HD): Over the past few decades, Western researchers have gradually begun to look East to find new drugs that can effectively treat some of our most incurable diseases.

Very often, researchers experiment with botanical drugs because they are generally biocompatible and biodegradable, very safe to use, and patients generally do not develop drug resistance, which happens with many synthetic drugs. For example, chloroquine phosphate is one of the most commonly used synthetic antimalarial drugs. What happens if a patient develops resistance to this designer drug? Try another synthetic compound? No, the researchers found that when botanical drugs derived from the dried leaves of the artemesia plant were given to malaria patients who failed standard drug treatment, all recovered completely after five days.

Researchers have also learned over the past few decades that a single compound of a synthesized drug may sometimes not be effective in treating certain diseases if it works alone. Botanical drugs, on the other hand, are already complex mixtures and can act together to generate a synergistic effect.

Currently, there are over 500 pending FDA applications for plant-derived drugs. The interest stems from their better safety profile, fewer side effects and long human experience, as well as a desire to address the strong Asian market, where herbal medicines remain widely used. .

BSp: How are organic products different from traditional Chinese medicine?

High Definition: Traditional Chinese Medicine (TCM) generally involves minimal alteration of the roots, flowers, stems and leaves of the plant, which are then combined with a tea or broth for consumption. Today’s botanical medicines use active pharmaceutical ingredients that are extracted and concentrated from plants. Any unwanted ingredients or compounds in the plants are removed during the production process.

BSp: What’s in your pipeline?

HIGH DEFINITION: Our product portfolio includes medical device, central nervous system (CNS) drugs and oncology drugs:

  • Vitargus® (ABV-1701) is an in situ-forming injectable hydrogel designed for use in the treatment of retinal detachment following retinal repair surgery. It is defined as a medical device and not as a therapeutic drug. After retinal reattachment, the patient does not need to be positioned face down.

Early human trials showed immediate improvement in visual acuity after surgery. It allowed patients to have unrestricted movement and required no postoperative fluid removal as Vitargus is completely biodegradable. A phase II clinical trial will begin in early 2022 with sites in Australia and Thailand.

In December 2021, Vitargus® received the National Innovation and Diligence Renewal Award from the Taiwan Institute of Biotechnology and Medical Industry.

  • In the CNS, ABV-1504 is a single-herb botanical medicine that is extracted from the dry root of Polygala tenuifolia Willd. Known as yuanzhi, it is a traditional Chinese medicine for the treatment of major depressive disorder (MDD).

At six weeks, a phase II trial showed a 52% response rate versus 35% for placebo and a mean change of 13.2 points from baseline using the Depression Rating Scale of Montgomery-Åsberg (MADRS). In contrast, fluoxetine (Prozac®) caused a mean change of 8.8 points from baseline. Administered in capsule form, ABV-1504 is stable at room temperature for at least 36 months.

We have recently completed a draft Phase III study protocol and will begin licensing discussions with major pharmaceutical companies who have been following the progress of ABV-1504. We anticipate that a phase III trial will be conducted in collaboration between ABVC and our licensing partners. The schedule will be determined following these discussions.

  • ABV-1505 is being developed to treat Attention Deficit Hyperactivity Disorder (ADHD), also using the active ingredient found in P. tenuifolia Willd. It works as a selective norepinephrine re-update (NET) inhibitor and has completed a phase II trial.

Simply put, norepinephrine is a neurotransmitter. The more neurotransmitters retained in the nervous system, the more nerve impulses can be transmitted. More nerve impulses have been shown to improve attention deficit and hyperactivity symptoms, and allow more focus on a specific task.

  • BV-1601, a Phase I clinical study for the treatment of MDD in cancer is expected to be completed by the end of 2022.
  • For oncology, we are developing ABV-1501 for triple negative breast cancer, ABV-1703 for pancreatic cancer and ABV-1702 for myelodysplastic syndrome. Each is the subject of a phase II clinical study.

The compounds are based on Maitake BLEX-404, a botanical extracted from the fruit body of maitake mushrooms (Grifola frondose, also called Hen of the Woods). It is grown in northeast Japan and northeast America.

A phase I/II trial involving 34 breast cancer patients showed that the patients were disease-free at the end of the trial and that the compound showed no dose-limiting effects. It appeared immunologically stimulating and measurable inhibitory effects were observed.

BSp: What’s next for ABVC Biopharma?

HD: This year, ABVC will seek a Phase III partner to advance ABV-1504 for MDD. We will also initiate a self-funded pivotal phase trial for Vitargus®, with a U.S. Food & Drug Administration Premarketing Approval (PMA) application targeted for 2024. We anticipate funding to support phase trials IIs for oncology and ADHD drugs, as well as to add new indications to our pipeline.

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