ST Pharm's New HIV Drug Secures Clinical PoC... Technology Transfer Put to the Test

Up to 97.5% Reduction in Viral Load Observed in Phase 2a Trial
Novel ALLINI Mechanism Distinguished from Existing Therapies
Key Focus on Combination Development and Securing Global Partners

ST Pharm has confirmed the antiviral efficacy of its independently developed oral candidate drug for Human Immunodeficiency Virus (HIV), based on a novel mechanism of action. The main advantage is its mode of action, which does not overlap with established treatments such as once-daily combination pills and long-acting injectable therapies. The next milestones include subsequent combination clinical trials and global technology transfer.

According to the Financial Supervisory Service’s DART system on July 16, ST Pharm recently reported that, in its US Phase 2a clinical trial of STP0404 for adult patients with HIV-1 infection, all dosage cohorts showed a statistically significant reduction in blood viral load compared to the placebo group. Patients took STP0404 at 200 mg, 400 mg, or 600 mg, or a placebo, once daily for 10 days. On day 11 of administration, the reduction in HIV-1 RNA was 1.50 logs for the 200 mg group, 1.18 logs for the 400 mg group, and 1.61 logs for the 600 mg group. When converted to reduction rates, these equate to approximately 96.8%, 93.4%, and 97.5%, respectively. No serious adverse events occurred.

ST Pharm Banwol Campus, Ansan, Gyeonggi Province. ST Pharm

STP0404 is an allosteric integrase inhibitor (ALLINI). While existing integrase inhibitors block the process in which viral genetic material is inserted into host cells, STP0404 induces abnormal binding of the integrase protein, thereby preventing the virus from maturing properly. The significance of this clinical trial lies in the proof-of-concept that this mechanism delivers antiviral effects in actual patients. Lee Soo Jung, researcher at IBK Investment & Securities, analyzed, “STP0404 operates via a different mechanism than existing treatments, which gives it the potential to be used as a new combination option. Moreover, its favorable tolerability profile demonstrated in this trial increases the likelihood of partnerships and technology transfer for further development.”

For HIV treatment, it is common to use drugs with different mechanisms together to prevent the development of drug resistance. STP0404 is therefore more likely to be developed as a new component added to current treatment combinations, rather than as a monotherapy to replace existing drugs. Detailed data, which will reveal specifics of the development direction, will be released at future international academic conferences.

Taking into account limited development costs and the low success rate of new drug commercialization, ST Pharm is pursuing a strategy of verifying efficacy and safety through Phase 2 clinical trials, followed by securing technology transfer and active pharmaceutical ingredient (API) supply rights. The company aims to develop its own new drugs based on its oligonucleotide contract development and manufacturing organization (CDMO) business, thereby realizing both technology transfer revenue and API supply sales.

The securities industry expects stable CDMO performance to support the subsequent development and technology transfer negotiations for STP0404. Hanwha Investment & Securities forecasts that, thanks to the growing volume of commercialized oligonucleotide APIs, ST Pharm’s operating profit this year will increase by 56.1% compared to the previous year. As the company’s main business generates more cash, it will gain more capacity to independently push forward with portfolio clinical trials, allowing it to secure more favorable technology transfer terms without rushing into a deal.

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