Open Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome (FLINTLOCK)

[forestglip]

Official Title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome (FLINTLOCK)

Brief Summary
This Phase 2a, randomized, double-blind, placebo-controlled, proof-of-concept study is being conducted to investigate the safety (whether there are any side effects), tolerability (if it does cause side effects, how well your body handles them), pharmacokinetics (PK) (how a drug is taken into your body, spread throughout, broken down, and eliminated), clinical activity (does the drug make patients feel better), immunogenicity (how the immune system responds to the drug), and serum virus neutralizing antibody response (antibodies that block a virus from infecting cells) of VYD2311, the investigational monoclonal antibody being studied, in adults with Long-COVID or Post-Vaccination Syndrome.

Participants will receive an intravenous (IV) infusion on Day 1 of either the investigational drug or placebo followed by two intramuscular (IM) injections (a shot in the upper arm), one on day 30 and the other on Day 60. The IM injections will also either be investigational drug or placebo. The participants will be then asked to complete a 30-day follow up period and end the study on day 90.

Intervention/Treatment

• Drug: VYD2311
• Drug: Placebo

Study Start (Estimated)
2026-10

Primary Completion (Estimated)
2027-06

Study Completion (Estimated)
2027-06

Enrollment (Estimated)
130

Phase
Phase 2

ClinicalTrials.gov

clinicaltrials.gov

 

[fst]

https://investors.invivyd.com/node/9796/html

About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart

So, basically Pemgarda V2?

 

[V.R.T.]

If this trial fails I really hope these teams will start investigating other potential mechanisms therapeutically.

I would have loved to see a CD38 trial or T cell targeting trial with this kind of turnaround. Or maybe some kind of dopaminergic or orexin drug based on the brain studies we've seen recently.

 

[BrightCandle]

The short followup time after the final treatment is never a good idea with this disease. Needs to be a fair bit longer as does determining baseline before the treatment just due to the natural variance over time.

 

[V.R.T.]

The short followup time after the final treatment is never a good idea with this disease. Needs to be a fair bit longer as does determining baseline before the treatment just due to the natural variance over time.

Good point

 

[Utsikt]

The entire trial is as long as the pre-treatment baseline phase of the dara trial.