Insilico Medicine Doses First Patient in Phase IIa Trial of Garutadustat for Inflammatory Bowel Disease
Insilico Medicine has dosed the first patient in its Phase IIa clinical trial of Garutadustat, an AI-designed small-molecule therapy being developed for Inflammatory Bowel Disease (IBD), specifically ulcerative colitis. This milestone reflects Insilico’s strategy of using generative artificial intelligence to rapidly discover and optimize drug candidates for complex diseases. Garutadustat is a gut-restricted prolyl hydroxylase (PHD) inhibitor designed to reduce intestinal inflammation while strengthening the gut lining, a key factor in IBD pathology.
The Phase IIa study, known as BETHESDA, is a randomized, double-blind, placebo-controlled trial enrolling around 80 patients. It will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy, including symptom relief, mucosal healing, and biomarker improvement. By limiting drug exposure primarily to the gut, Garutadustat aims to minimize systemic side effects while maximizing therapeutic benefit at the disease site.
Earlier Phase I studies in Australia and China showed that the drug was well tolerated, with favorable absorption and distribution characteristics. This supported its advancement into patient trials. The program also demonstrates the speed of Insilico’s AI-driven platform, as Garutadustat moved from target identification to human testing in only a few years—much faster than traditional drug development timelines.
If successful, Garutadustat could represent a first-in-class therapy that not only suppresses inflammation but also promotes repair of the intestinal barrier, offering a potentially more durable solution for IBD patients who fail existing biologics or immunosuppressants.
Sustained Therapeutics Announces Positive Phase 2 Results for Long-Acting Non-Opioid Chronic Pain Therapy
Sustained Therapeutics has reported positive Phase 2 results for ST-01, a long-acting, non-opioid treatment for chronic pain. ST-01 is a sustained-release formulation of lidocaine designed to provide prolonged pain relief from a single localized administration, reducing the need for frequent dosing or opioid-based therapies.
The Phase 2 trial compared ST-01 plus standard care to standard care with traditional lidocaine. Results showed that patients receiving ST-01 experienced significant and sustained reductions in pain over multiple treatment cycles. Importantly, the therapy met both primary and secondary endpoints, indicating meaningful improvement in pain scores compared with controls.
Safety was also favorable, with ST-01 being well-tolerated and not associated with serious adverse effects. This is particularly important in chronic pain, where long-term safety and dependency risk are major concerns. Unlike opioids, ST-01 does not act on the central nervous system, eliminating the risk of addiction and respiratory depression.
The drug uses Sustained Therapeutics’ proprietary polymer-gel technology, which slowly releases lidocaine at the treatment site, maintaining therapeutic levels for weeks rather than hours or days. This could significantly reduce treatment burden for patients suffering from persistent pain.
Given the strong Phase 2 data, the company plans to advance ST-01 into Phase 3 trials in North America. If successful, ST-01 could become a major non-opioid alternative in chronic pain management.
ZYUS Life Sciences Reports Initial Findings from Phase 2a UTOPIA-1 Study in Pain Management
ZYUS Life Sciences has released encouraging preliminary data from its Phase 2a UTOPIA-1 trial, which evaluates Trichomylin softgel capsules for the management of moderate to severe cancer-related pain. The UTOPIA-1 study (Unique Treatment of Oncology Pain in Advanced Cancer) is a single-arm, proof-of-concept trial focused on patients with advanced malignancies who require better pain control than current standards provide.
The initial findings, based on the first 25% of enrolled patients, indicate a positive trend in efficacy. Participants experienced notable reductions in average daily pain, pain interference with daily activities, and overall pain severity. Perhaps most significantly, the data showed a decrease in the dosage of opioids required for breakthrough pain, suggesting that Trichomylin could serve as a vital “opioid-sparing” agent.
Trichomylin is a cannabinoid-based pharmaceutical candidate developed through seven years of scientific research. In the trial, the drug was generally well-tolerated; most adverse events were mild and occurred during the initial dose-titration phase. No serious treatment-related adverse events have been reported to date. As the trial continues toward full enrollment, ZYUS aims to validate these early signals to support progression into later-stage pivotal trials. The goal is to provide oncology patients with a regulated, non-opioid alternative that mitigates the risks of dependency and the debilitating side effects often associated with heavy opioid use.
Merck Launches Phase 3 KANDLELIT-007 Trial of Calderasib (MK-1084) Plus KEYTRUDA QLEX in Advanced NSCLC
Merck has initiated the Phase 3 KANDLELIT-007 trial, a major global study evaluating a new combination therapy for patients with KRAS G12C-mutant advanced or metastatic non-small cell lung cancer (NSCLC). The trial tests the investigational oral KRAS G12C inhibitor calderasib (MK-1084) in combination with KEYTRUDA QLEX, a subcutaneous formulation of the blockbuster immunotherapy pembrolizumab.
The KRAS G12C mutation is found in roughly 4% to 14% of NSCLC cases and has historically been a difficult target for drug developers. This trial is designed to compare the calderasib and KEYTRUDA QLEX duo against the current standard of care: KEYTRUDA combined with intravenous chemotherapy (pemetrexed and platinum-based agents). The primary goal is to improve progression-free survival (PFS) in patients whose tumors express the PD-L1 biomarker.
A key highlight of this study is its move toward a chemotherapy-free and intravenous-free treatment regimen. KEYTRUDA QLEX uses a hyaluronidase alfa-pmph to enable subcutaneous delivery, significantly reducing administration time and improving patient convenience compared to traditional IV infusions. By pairing this with an oral inhibitor like calderasib, Merck is exploring a frontline treatment that could offer better efficacy with a much lower treatment burden. The trial intends to enroll approximately 675 patients worldwide, marking it as a cornerstone of Merck’s strategy to expand the utility of KEYTRUDA into more targeted, mutation-specific combinations.
Sanofi’s Teizeld Receives EU Approval for Stage 2 Type 1 Diabetes
Sanofi has received European Union approval for Teizeld (teplizumab) to delay the progression of Stage-2 type 1 diabetes (T1D) in adults and children aged eight and above. This makes Teizeld the first disease-modifying therapy approved in the EU for early-stage autoimmune diabetes.
Stage-2 T1D occurs when the immune system has already begun attacking insulin-producing cells but symptoms have not yet appeared. Without intervention, most patients progress to Stage-3, requiring lifelong insulin therapy. Teizeld works by targeting immune T cells responsible for destroying pancreatic beta cells, slowing the disease process. Teizeld is a CD3-directed monoclonal antibody that works by modulating the T cells that mistakenly attack insulin-producing beta cells in the pancreas. The approval was based on the TN-10 study, which showed that a single 14-day course of Teizeld delayed the diagnosis of Stage 3 T1D by a median of two years. This delay is life-changing for families, as it grants patients more time before they must begin the lifelong, burdensome regimen of daily insulin injections. Teizeld stands as the first and only disease-modifying therapy for T1D in the EU, shifting the medical focus from treating symptoms to proactively delaying the disease’s progression.
Clinical trials showed that Teizeld could delay the onset of full diabetes by about two years on average. This delay is clinically meaningful, especially for children, as it postpones insulin dependence and the risks associated with uncontrolled blood sugar.
The drug has already been approved in several other countries, and EU authorization expands access to a therapy that shifts diabetes care from treatment to prevention and disease modification. Teizeld represents a major advance in autoimmune medicine, opening the door to earlier intervention and better long-term outcomes for patients at high risk of type 1 diabetes.
