Kodiak Sciences dosing subjects in Phase III trial of diabetic retinopathy drug

Clinical Trials Arena· SUPERMAO / Shutterstock.
GlobalData
2 min read
0
In this article:

US-based biotechnology company Kodiak Sciences has dosed the first subjects with diabetic retinopathy (DR) in its Phase III GLOW2 clinical trial of tarcocimab tedromer.

The randomised, multi-centre trial will assess the efficacy and safety of tarcocimab tedromer in treatment-naïve DR patients.

Patients are being randomised at a 1:1 ratio to receive intravitreal injections of tarcocimab tedromer at baseline, week four, week eight, week 20 and week 44.

The proportion of eyes showing an improvement of at least two steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at week 48 is the trial’s primary endpoint.

Further outcome measures will assess the proportion of eyes that develop sight-threatening complications of DR and the proportion of eyes improving by three or more steps on the DRSS from baseline at week 48.

Kodiak Sciences aims to finish enrolling subjects in the study by the end of this year.

If successful, the trial could help the company secure a marketing authorisation application for tarcocimab tedromer.

The GLOW2 trial's study design is similar to that of the previous GLOW1 study, which found an 89% reduction in the risk of sight-threatening complications among patients treated with tarcocimab tedromer.

Kodiak Sciences CEO Dr Victor Perlroth said: “The GLOW1 data showed unequivocally that treatment with tarcocimab in extended dosing intervals, including six-month dosing in all patients, achieved two related but clinically distinct goals: treating existing disease (primary endpoint of two-step improvement in DRSS) and preventing disease progression (key secondary endpoint of preventing sight-threatening complications).

“This is a key differentiator in the long-acting therapy space, where many therapies are only designed to maintain a patient's current disease status and not to improve it.”

In September last year, Kodiak Sciences released topline results from a Phase III trial of discontinued tarcocimab tedromer in patients with macular oedema caused by retinal vein occlusion.

"Kodiak Sciences dosing subjects in Phase III trial of diabetic retinopathy drug" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.


 


The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.

Advertisement

Recommended Stories

  • Moderna Stock Had a Very Bad Day. Here’s Why.

    The drop comes as Moderna awaits important developments involving its experimental cancer treatment, a new respiratory vaccine, and a possible avian flu vaccine under development.

  • The Next Humira? Insmed Catapults 119% On Its 'Very Attractive' Opportunity In Lung Disease.

    Insmed stock catapulted Tuesday after the biotech company's experimental lung disease treatment succeeded in a final-phase study.

  • Moderna (MRNA) Stock Outperformed Industry YTD: Here's Why

    Shares of Moderna (MRNA) are being driven by encouraging pipeline updates and plans for potential product launches.

  • Insmed Stock Surges on Trial Win for Lung-Condition Drug. ‘We Hit the Mark,’ CEO Says.

    Analysts had said shares could more than double if the trial was a success, or fall by more than half if it failed. The drug brensocatib, treats a condition called bronchiectasis.

  • Merck's Multi-Billion Cancer Drug Keytruda Aces Late-Stage Breast Cancer Study (UPDATED)

    Editor’s Note: The title of the story is updated to correct the reference to ‘Breast’ cancer instead of ‘Lung’ cancer. Tuesday, Merck & Co Inc (NYSE:MRK) released topline data from hase 3 KEYNOTE-522 trial of Keytruda in high-risk early-stage triple-negative breast cancer (TNBC). The study evaluated Keytruda in combination with chemotherapy as a pre-operative (neoadjuvant) treatment and then continuing as a single agent after surgery (adjuvant). The study met its overall survival (OS) endpoint.

  • Why Is Inflammatory Diseased-Focused Insmed Stock Soaring On Tuesday?

    Insmed Incorporated (NASDAQ:INSM) shares are trading higher after the company released topline results from the ASPEN Phase 3 study of brensocatib in patients with non-cystic fibrosis bronchiectasis. Non–cystic fibrosis bronchiectasis is a chronic inflammatory condition of the lungs associated with respiratory infections, daily coughing, and sputum. The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized r

  • Candel (CADL) Stock Skyrockets 431% Year to Date: Here's Why

    Candel (CADL) surges 431% in the year-to-date period, driven by positive developmental and regulatory updates from the clinical program for CAN-2409 across two different cancer indications.

  • Johnson & Johnson Agrees to Buy Numab Unit, Investigational Skin Disease Treatment For $1.25 Billion

    Johnson & Johnson Agrees to Buy Numab Unit, Investigational Skin Disease Treatment For $1.25 Billion

  • Insmed Shares Rocket After Drug Eases Lung Disease Symptoms

    (Bloomberg) -- Insmed Inc. shares more than doubled after the company’s experimental drug reduced episodes of worsening symptoms in a final-stage study of patients with a rare lung condition. Most Read from BloombergWall Street Moves to Fastest Settlement of Trades in a CenturyTreasuries Hit as US Sales Struggle to Lure Buyers: Markets WrapFor Private Credit’s Top Talent, $1 Million a Year Is Not EnoughIsraeli Airstrike and Egyptian Guard’s Death Ratchet Up TensionsCatering to the Ultra-Rich Is

  • Farmers must kill 4.2 million chickens after bird flu hits Iowa egg farm

    More than 4 million chickens in Iowa will have to be killed after a case of the highly pathogenic bird flu was detected at a large egg farm, the state announced Tuesday. Crews are in the process of killing 4.2 million chickens after the disease was found at a farm in Sioux County, Iowa, making it the latest in a yearslong outbreak that now is affecting dairy cattle as well. Last week, the virus was confirmed at an egg farm west of Minneapolis, Minnesota, leading to the slaughter of nearly 1.4 million chickens.