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ABVC: Enrollment in ABV-1505 Part 2 ADHD Clinical Study Continues; First Patient Begins Treatment

By M. Marin NASDAQ:ABVC READ THE FULL ABVC RESEARCH REPORT Lead assets moving forward…

Benzinga · 06/12/2022 13:41

By M. Marin



Lead assets moving forward…

ABVC BioPharma (NASDAQ:ABVC) is a biopharma and medical device company developing therapies for a range of conditions focused on oncology/hematology, central nervous system (CNS) and ophthalmology. ABVC has two lead assets moving through advanced stages of development. The first participant in ABVC's Part 2 ADHD clinical study of ABV-1505 began treatment in May and 13 additional participants joined the study earlier this month. The study is expected to enroll about 100 patients in the U.S. and Taiwan. All five participating sites in Taiwan have completed site initiation visits (SIV).

The active ingredient in ABV-1505 is PDC-1421. The company is seeking a Phase III partner to advance studies of PDC-1421 in trials evaluating its efficacy in treating to major depression disorder (MDD). ABVC also recently hired two doctors to provide consulting services on its clinical study activities related to MDD and ADHD.

Vitargus study moving forward with investigator meeting…

ABVC is also launching a pivotal trial for Vitargus®, the company's bio-degradable vitreous substitute that ABVC believes has several advantages compared to existing vitreous substitutes, including that it minimizes medical complications and lowers the risk of a patient requiring additional surgeries. The objective of the study is to demonstrate the safety and efficacy of Vitargus as compared to SF6 Gas OE, which is a standard of care for retina reattachment.

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. In 2Q22, a meeting attended by all principal investigators from the Australian and Thailand sites was conducted virtually to move the study forward. The company has also recently improved and streamlined the manufacturing of Vitargus.

… as ABVC adds new incremental revenue streams

The company has added incremental revenue streams to help support its development and growth efforts. For example, a Taiwan-based medical device company, Orion BioTech, recently engaged ABVC to identify candidates interested in licensing Orion deals. ABVC will earn a monthly retainer fee and 15% of the licensing income and royalties Orion generates for each product licensed.

Another initiative that is expected to generate incremental fee revenue is that ABVC entered into a $3.0 million clinical services contract with NeuCen BioMed to guide two NeuCen drug products, CEN501 and NEU001, through the completion of Phase II clinical studies towards FDA IND regulatory requirements.

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