Aribio "Aiming to Complete Phase 3 by End of Next Year... Prototype Production Already Started"

"We have confidence in our technology. We aim to complete the Phase 3 clinical trial dosing by the end of next year. We will become the global leader in degenerative brain diseases."

Jaejun Jeong, CEO of Aribio, is being interviewed by Asia Economy in San Diego, California, USA, where the 2024 Bio International Convention (BIO USA) is being held.
[Photo by Chunhee Lee]

At the 2024 BIO International Convention (BIO USA) held in San Diego, California, USA, on the 5th (local time), Jaejun Jung, CEO of Aribio, said, "The patient enrollment for the ongoing Phase 3 clinical trial of AR1001 is expected to be roughly completed by the end of this year," and confirmed the smooth progress of the trial by adding, "Since it is a one-year dosing trial, we aim to complete dosing by the end of 2025."

AR1001 is a therapeutic agent aimed at an oral dementia treatment with multiple mechanisms of action. It is explained to have efficacy in inhibiting dementia progression and improving patients' memory and cognitive functions through a strong phosphodiesterase (PDE) 5 inhibitory effect. The mechanism can be broadly divided into three parts. First, it suppresses the intracellular production of amyloid-beta protein, which is considered one of the key factors in Alzheimer's dementia. While antibody therapies, which currently dominate dementia treatments, work by removing amyloid accumulated outside cells in the brain, AR1001, being a synthetic chemical drug, has a smaller molecular structure that allows it to penetrate cells and remove amyloid through autophagy, thereby inhibiting its accumulation.

The Phase 3 clinical trial is being conducted on early Alzheimer's patients across more than 200 clinical centers in 11 countries, including South Korea, the United States, the United Kingdom, seven European Union (EU) countries, and China. CEO Jung explained, "Out of over 170 meeting requests received at this BIO USA, we handled about 70," and added, "The number of meeting requests has increased as we conduct global Phase 3 trials."

This Phase 3 trial was designed efficiently, considering recent regulatory situations and cases such as Biogen and Eisai's Leqembi, which was recently approved in South Korea, and Eli Lilly's Donanemab, which is on the verge of FDA approval. Unlike Leqembi and Donanemab, which conducted trials over 18 months, AR1001's trial is conducted over only 52 weeks. CEO Jung explained, "This is because the FDA recently changed its guidelines," adding, "Even if the trial is longer, it is difficult to confirm efficacy, but approval can be granted if biomarkers show precise changes." Accordingly, the Phase 3 trial of AR1001 will observe various biomarker changes, including cerebrospinal fluid (CSF) and plasma, in addition to the general cognitive function indicator Clinical Dementia Rating-Sum of Boxes (CDR-SB). Regarding conducting multinational trials that encompass major regulatory agencies at once, he expressed confidence, saying, "Looking at currently approved treatments, regulatory agencies have different perspectives, so a drug may be approved in one place but not in another. While it is possible to conduct separate trials, considering the movements of the FDA and the European Medicines Agency (EMA), we believe it is better to proceed together."

[Photo by Aribio]

The goal of the meetings at this BIO USA is to find marketing partners. Since the Phase 3 trial is now on track, discussions need to focus not on technology transfer but on how to actually sell the drug. CEO Jung emphasized, "Since we need to get the drug to patients quickly, it is time to find marketing partners for joint marketing and other efforts," adding, "We have already started producing prototypes to handle initial post-market supply."

Domestically, a Phase 3 clinical trial and future licensing agreement have already been signed with Samjin Pharmaceutical. CEO Jung said, "When asked why we partnered with Samjin instead of a bigger company, I replied, 'They were the first to recognize us as a partner and stand with us when we were struggling, even though others didn’t pay attention,'" and explained, "They have a strong will to grow the company as an owner family and have a powerful brand called Geborin, which we viewed positively." He continued, "If you are Korean, you should help Korean companies grow globally and build capabilities together," adding, "Therefore, we are collaborating with Samjin Pharmaceutical on production and with Neurofit on image analysis." Neurofit, a Korean brain disease imaging artificial intelligence (AI) solution company, is cooperating as an image-specialized clinical research organization (CRO) in the Phase 3 clinical trial of AR1001.

Regarding listing, specific plans will be presented soon. They are considering not only domestic listing but also listing on NASDAQ. There is also the possibility of a reverse merger through a merger with Solux, a KOSDAQ-listed company where CEO Jung holds a 41.4% stake (including warrants) and also serves as CEO.