▎WuXiEdited by Kant Content Team

Potential First-in-Class, Low-Dose Atropine Eye Drops Submit New Drug Application

Sydnexis announced today that the U.S. FDA has accepted the company’s New Drug Application (NDA) for its investigational therapy SYD-101, with a review expected to be completed by October 23, 2025. The press release noted,If approved, SYD-101 will become the first drug approved by the U.S. FDA for the treatment of myopia progression in children.

The NDA submission is based on the primary and secondary endpoint data from the Phase 3 clinical trial, the STAR study. The study aims to evaluate the effect of SYD-101 in slowing the progression of myopia and the associated risk of complications in children.SYD-101 is an investigational low-dose atropine sulfate ophthalmic solution designed to achieve therapeutic efficacy for pediatric myopia while enhancing pharmacological stability and reducing discomfort to improve treatment continuity.SYD-101 does not require pH reduction and can maintain a shelf life of up to 3 years at room temperature.

Aiming for Functional Cure of HIV Infection, Early Clinical Results of T Cell Receptor (TCR) Therapy Positive

Immunocore recently announced preliminary data from the multiple ascending dose (MAD) portion of the Phase 1/2 clinical trial, STRIVE, for its investigational therapy IMC-M113V in treating people with HIV. The data shows,IMC-M113V was well-tolerated and showed dose-dependent control of the virus after interruption of antiretroviral therapy (ART).The MAD part of the trial is still ongoing, evaluating higher doses, and will subsequently establish one or more extended cohorts at different dose levels.

IMC-M113V utilizes a T cell receptor to bind to the HLA-A*02:01-Gag complex on HIV-infected immune cells. The anti-CD3 effector arm of this molecule then recruits T cells to destroy CD4-positive cells containing integrated HIV DNA, eliminating so-called viral reservoirs.

The MAD portion of the Phase 1/2 dose-escalation trial enrolled 16 HIV-infected individuals who were stable on ART. While continuing ART, three patient cohorts received weekly intravenous infusions of IMC-M113V at doses of 60 micrograms (n=5), 120 micrograms (n=5), and 300 micrograms (n=6) for 12 weeks, followed by an analytical ART treatment interruption (ATI) for up to 12 weeks, after which participants resumed their previous ART regimens.

Among 15 evaluable HIV-infected individuals, delayed viral rebound during ATI was observed in one participant from the 120 µg cohort and two participants from the 300 µg cohort. The viral load of these three patients exhibiting viral control was approximately 200 c/mL at week 8. Additionally, two of these three patients remained off ART throughout the pre-specified 12-week ATI period.

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