By M. Marin
Moving lead assets and earlier stage candidates forward …
ABVC BioPharma (NASDAQ:ABVC), a biopharma and medical device company developing therapies for a range of conditions focused on oncology/hematology, central nervous system (CNS) and ophthalmology, provided an update in a letter to shareholders this week. With a broad pipeline of therapies to treat challenging diseases, including in oncology and depression, ABVC is optimistic about prospects for lead assets obtaining regulatory approval with the FDA and in international markets.
Therapies derived primarily from natural ingredients, minimizing potential side-effects
Importantly, ABVC’s products are derived primarily from plants and botanicals and have already demonstrated therapeutic benefits, while simultaneously minimizing potential side-effects compared to therapies developed from animals or chemicals. ABVC therefore believes its pipeline is well-positioned to attain regulatory approval with the FDA and other regulators in international markets.
Looking ahead to Vitargus partnership prospects in Asia…
Through the remainder of 2022 and into 2023, ABVC expects to complete several goals. These include completing Vitargus Phase II trials in Thailand, Australia and Taiwan. Vitargus is the company’s medical device focused on eye surgery.
ABVC is optimistic about Vitargus and believes the revenue prospects for Vitargus could begin to be realized fairly shortly after the Vitargus clinical trial is completed. Specifically, ABVC expects that the successful demonstration of Vitargus can result in distribution agreements in Asia. Earlier this month, ABVC announced a new clinical site in Australia at the Sydney Eye Hospital. In participating in the study, Sydney Eye Hospital joins: East Melbourne Eye Group in East Melbourne, Australia Ramathibodi Hospital and Srinagarind Hospital in Thailand.
Earlier clinical studies indicate that Vitargus has unique properties that eliminate the need for post-surgery patient face-down positioning and significantly improves recovery period patient comfort and visual acuity compared to existing products. The company recently improved and streamlined the manufacturing of Vitargus.
… while also advancing therapies focused on MDD
The company also expects to conclude discussions with the FDA to derive an acceptable protocol for Phase III trials for MDD (major depression disorder). The company credits relationships with researchers such as Harvard Medical’s Dr. Fava and its principal investigators with helping to move its asset portfolio forward. With the assistance of Dr. Fava, ABVC expects to finalize discussions with the FDA on an acceptable protocol for Phase III trials for MDD.
This would be a significant step forward that would enable the company to find potential distribution partners for its pipeline of various therapies designed to treat central nervous system (CNS) diseases.
This also represents an example of ABVC’s strategy to extend the potential reach and commercial applications of the various drug candidates in its growing pipeline. The active ingredient of ABV-1505, ABV-1504 (illustrated in figure above) and ABV-1601 is PDC-1421, which is a botanical investigational new drug (IND). In addition to moving ABV-1505 forward through phase II part II clinical trials for treatment in ADHD, ABVC has expanded the program to study the formulation’s efficacy in treating MDD.
… and oncology …
Moreover, consistent with the company’s strategy to leverage its assets for multiple treatment programs in order to extend their potential reach and commercial application, ABVC intends to complete Phase II clinical trials for at least one of its oncology drugs and commence Phase II trials for other oncology drugs, as well as expand the pipeline to include developing technologies in genomic medicine and cell therapy.
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