Capsaicin

Kolon TissueGene's efforts to bring its experimental cell-based gene therapy for osteoarthritis of the knee (OAK) to the US have hit a stumbling block. The company revealed Monday that the first of two Phase III studies testing TG-C failed to meet its primary goals, with hopes now resting on the second trial, where results are due in October.TG-C joins a list of osteoarthritis setbacks in recent years, following Novartis's ADAMTS-5 inhibitor QUC398, Ampio Pharmaceuticals' OA-201 programme, and Centrexion Therapeutics' non-opioid analgesic CNTX-4975.TG-C is an allogeneic cell and gene therapy consisting of human donor chondrocytes and irradiated GP2-293 cells expressing TGF-β1. It is administered as a one-time, single dose via intra-articular injection into the knee.Pain, function endpoints missedThe ACTiVION-II study randomised 531 patients with Kellgren–Lawrence grade 2 or 3 OAK and compared TG-C against placebo. The trial failed to show statistically significant improvements in either Visual Analogue Scale (VAS) pain scores or Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores after 12 months, missing both co-primary endpoints as well as all key secondary endpoints.The therapy was generally well tolerated, with no new safety signals and adverse events comparable to placebo."We continue to analyse the full data set for additional insights," said co-CEI Seng Ho Jeon in a company release.The results leave the programme's future on shaky ground, resting largely on ACTiVION-I, the second US Phase III study being conducted under a Special Protocol Assessment agreement with the FDA. The company said it will determine its next steps after reviewing those data.This is the latest twist in TG-C's rocky regulatory path. The therapy won approval in South Korea in 2017 as Invossa, becoming one of the first cell and gene therapies cleared for OAK, but regulators there revoked that approval in 2019 after determining that one of its cell components originated from kidney cells rather than the cartilage cells originally described in its approval.The disclosure prompted the FDA to place US studies on a clinical hold before allowing the programme to resume following a review.

GOTHENBURG, Sweden, May 8, 2026 /PRNewswire/ -- The recruitment represents a significant strategic addition to the company as it continues the development of its innovative drug platform within pain and inflammatory diseases. Dr. Lundberg has had a long and highly successful international career spanning both academia and the global pharmaceutical industry. He began his career as a researcher and professor at the Karolinska Institute and established himself at a very early stage as one of the world's 100 most cited scientists. He subsequently joined AstraZeneca, where he held leading positions within research and development before being recruited to Eli Lilly in the United States. There, he served for many years as Global Head of Research and was ultimately responsible for building the research portfolio that contributed to Eli Lilly becoming what is today the world's highest valued pharmaceutical company. Under Dr. Lundberg's leadership, several GLP 1 based medicines were developed, including therapies within the same drug class as Ozempic. These treatments from Eli Lilly have today become dominant in the treatment of metabolic diseases such as obesity and represent one of the pharmaceutical industry's most successful therapeutic areas. In addition to medicines for obesity and diabetes, he also successfully developed treatments for Alzheimer's disease and pain. Among other achievements, he was a pioneer in the development of antibody therapies for migraine and the extremely severe disorder cluster headache. Oblique Therapeutics is developing, among other programs, next generation antibody based ion channel therapeutics with a focus on TRPV1 and pain. Dr. Lundberg's scientific expertise and extensive experience in translational research, drug development, strategic portfolio building, as well as his broad industrial and academic network, will play an invaluable role in the continued development of Oblique's operations. Fun fact: Dr. Lundberg originates from Munkfors in the province of Värmland, Sweden, a region that has produced a disproportionately large number of successful Swedes, including Tage Erlander, Erik Gustaf Geijer, Lars Lerin, Bosse Parnevik and many others. Before dedicating himself fully to medicine and research, he was also a successful ice hockey player, including playing in both the United States and Canada. "I have been active in the research field surrounding capsaicin, TRPV1 and pain since its very earliest days, and it is extremely exciting to see the progress now being made by Oblique Therapeutics. The company's antibody based strategy has the potential to create a new and clear differentiation compared with small molecule TRPV1 blockers, which have been important in validating the significance of this ion channel in pain, but which have been limited by side effects during systemic treatment. The opportunity to contribute to the development of what could become a transformative treatment for patients suffering from chronic pain is therefore both scientifically and personally highly inspiring," says Dr. Lundberg. "We are extremely pleased and proud that Dr. Jan Lundberg has chosen to engage with Oblique Therapeutics. His unique scientific stature, industrial experience and proven ability to build successful pharmaceutical portfolios are invaluable to the company as we continue our development," says Christer Nordstedt, CEO of Oblique Therapeutics. For further information, please contact Christer Nordstedt MD PhD CEO Oblique Therapeutics AB Box 40091-9037 Datavägen 15D 436 32 Askim Mobil: +46 70 251 40 33 Email: [email protected] Web: This information was brought to you by Cision The following files are available for download: SOURCE Oblique Therapeutics AB 21% more press release views with Request a Demo