相关临床试验
5
3 进行中
药物批准
16
批准总数
监管机构
2
监管机构数
成立时间
1953
进行中（未招募）
3
60.0%
已完成
1
20.0%
招募中
1
20.0%
- The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in major depressive disorder failed to meet its primary MADRS efficacy endpoint at Day 5 versus placebo. - The M1 receptor antagonist was well tolerated with no new safety signals, and Johnson & Johnson is still analyzing prespecified exploratory endpoint data. - The miss is the second Phase 2 failure for the molecule, following the VISTA trial in relapsing-remitting multiple sclerosis in 2025. - Analysts removed the asset from financial models, shifting Contineum's valuation focus to its wholly owned LPA1 antagonist PIPE-791 for idiopathic pulmonary fibrosis.
- All 24 patients with inoperable, locoregionally recurrent NSCLC completed radiotherapy-activated JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities and no related Grade 3 or higher events. - At a median 12-month follow-up, one-year locoregional control reached 79%, one-year local progression-free survival 61% and one-year overall survival 70%. - Investigators concluded the hafnium oxide nanoparticle radioenhancer may permit clinically meaningful local control at a substantially lower re-irradiation dose than patients' prior radiotherapy course. - Enrollment in the dose-escalation and expansion phases is complete per protocol, and additional patients are now planned following the encouraging findings.
- The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 did not meet its primary efficacy endpoint in adults with major depressive disorder, Contineum Therapeutics reported. - The trial assessed improvement from baseline in MADRS total score at Day 5 versus placebo; the M1 receptor inhibitor was well-tolerated with no new safety signals. - Johnson & Johnson, which develops the drug under a global license agreement, is analyzing prespecified exploratory endpoints to assess clinical relevance and next steps. - Contineum separately affirmed its Phase 2 PROPEL-IPF trial of PIPE-791, now with more than 55 sites across eight countries, and a cash runway through mid-2029.
- Contineum Therapeutics announced positive topline data from its Phase 1b trial of PIPE-791, demonstrating favorable safety and tolerability in 43 patients with chronic osteoarthritis pain or chronic low back pain. - The LPA1 receptor antagonist showed encouraging trends across multiple exploratory efficacy endpoints, with patients demonstrating numerically greater improvements in pain measures compared to placebo. - PIPE-791 was administered as a once-daily 10mg oral dose and represents a potential non-opioid treatment option for chronic pain conditions. - The results support further clinical investigation of PIPE-791 for chronic pain treatment, with the company contemplating next steps for additional clinical development.
- Contineum Therapeutics has initiated patient dosing in PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for idiopathic pulmonary fibrosis, targeting 324 patients over 26 weeks with a primary endpoint of forced vital capacity change. - PIPE-791 demonstrates potential differentiation from Bristol Myers Squibb's competing LPA1 antagonist through achieving approximately 90% receptor occupancy at 1 mg daily dosing and showing no hypotension signal to date. - The company maintains financial runway through mid-2029 following a $93 million public offering, while also advancing PIPE-307 in partnership with Johnson & Johnson for major depressive disorder treatment. - Topline data from an exploratory PIPE-791 Phase 1b chronic pain trial is expected in Q2 2026, potentially supporting quality-of-life benefits in pulmonary fibrosis populations.
- Nanobiotix announced a strategic royalty monetization agreement with HealthCare Royalty providing up to $71 million in non-dilutive capital, extending the company's cash runway into early 2028. - The financing enables continued development of JNJ-1900 (NBTXR3), a first-in-class hafnium oxide nanoparticle therapy activated by radiotherapy, beyond key milestones in head and neck cancer and lung cancer trials. - HealthCare Royalty will receive capped milestone payments and royalties from JNJ-1900 sales, with repayment subject to caps of $124-178 million depending on timing. - The agreement establishes financial foundation for self-sustainability and advancement of next-generation nanotherapeutic platforms for long-term growth.
- Nanobiotix announced Phase 1 results for JNJ-1900 (NBTXR3) combined with immune checkpoint inhibitors in heavily pre-treated primary cutaneous melanoma patients resistant to anti-PD-1 therapy. - The study demonstrated a 47.4% objective response rate and 78.9% disease control rate in 19 evaluable patients, with a median overall survival of 14.6 months. - The radiotherapy-activated nanoparticle therapy showed a favorable safety profile and established a recommended Phase 2 dose at 33% of gross tumor volume. - Investigators observed a relationship between local response depth and systemic tumor regression, suggesting potential immune system re-activation in this difficult-to-treat patient population.
- Dr. Reddy's Laboratories has acquired the STUGERON brand from Johnson & Johnson for $50.5 million, expanding its central nervous system therapeutic portfolio across 18 markets in Asia-Pacific and EMEA regions. - The acquisition includes STUGERON, STUGERON FORTE, and STUGERON PLUS brands, featuring the anti-vertigo drug cinnarizine, which holds the first position in India's cinnarizine market and ranks second in the anti-vertigo extended market. - This strategic move aligns with Dr. Reddy's goal to reach over 1.5 billion patients by 2030 and strengthens its presence in the anti-vertigo therapeutic segment. - Following the acquisition announcement, Dr. Reddy's shares declined nearly 2%, trading at ₹1,295 per equity share amid investor reactions to the deal.
- European health authorities have reclassified JNJ-1900 (NBTXR3) from a medical device to a medicinal product, harmonizing its regulatory status with the US and other major markets. - Nanobiotix filed a new composition of matter patent for JNJ-1900 to strengthen the intellectual property foundation of the potential first-in-class radioenhancer. - The developments support the global positioning of JNJ-1900, which is currently undergoing comprehensive clinical development including a pivotal Phase 3 trial in head and neck cancer. - JNJ-1900 is composed of functionalized hafnium oxide nanoparticles administered via intratumoral injection and activated by radiotherapy to induce tumor cell death and immune response.
- Contineum Therapeutics announced positive topline data from its Phase 1b PET trial of PIPE-791, an LPA1 receptor antagonist being developed for idiopathic pulmonary fibrosis, progressive multiple sclerosis, and chronic pain. - The trial successfully assessed the correlation between pharmacokinetics and LPA1 receptor occupancy using PET imaging in 12 healthy volunteers and four progressive multiple sclerosis patients. - Based on brain receptor occupancy data, the company expressed confidence in planned doses for future Phase 2 proof-of-concept trials, with researchers believing brain distribution patterns can predict lung receptor occupancy. - PIPE-791 represents part of Contineum's pipeline of oral small molecule therapies targeting neuroinflammatory and immunological indications with significant unmet medical needs.
