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Clinical Trial News

Strides Pharma Gains FDA Approval for Generic Fluoxetine 60mg Tablets

  • Strides Pharma has received FDA approval for its generic Fluoxetine 60mg tablets, expanding its portfolio of this antidepressant drug.
  • The approval allows Strides Pharma to offer a complete range of Fluoxetine products, including 10mg, 20mg, and 60mg tablets and capsules.
  • Fluoxetine capsules and tablets have a combined market size of $130 million, offering a substantial commercial opportunity for Strides Pharma.
  • Strides Pharma plans to launch all three strengths of Fluoxetine tablets in the near future, manufactured at its facility in Puducherry.

PDS Biotech's Versamune® HPV Plus Pembrolizumab Shows Promising Results in HPV16-Positive Head and Neck Cancer

  • Updated data from the VERSATILE-002 trial shows a median overall survival of 30 months in patients treated with Versamune® HPV plus pembrolizumab.
  • The combination therapy achieved an objective response rate of 36% and a disease control rate of 77% in patients with HPV16-positive recurrent/metastatic HNSCC.
  • A significant portion of patients, 21%, experienced deep tumor responses with 90-100% tumor shrinkage, highlighting the therapy's potential.
  • PDS Biotech plans to initiate the VERSATILE-003 Phase 3 clinical trial to further evaluate the combination as a first-line treatment option.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial

• Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo. • The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation. • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, has received FDA Breakthrough Therapy Designation for IPF, with a new drug application planned for submission. • Full efficacy and safety data from the FIBRONEER-IPF trial will be presented in the first half of 2025, offering a comprehensive understanding of the drug's potential.

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

NCT05321082CompletedPhase 3
Boehringer Ingelheim
Posted 11/16/2022

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321069CompletedPhase 3
Boehringer Ingelheim
Posted 10/6/2022

FDA Approves Roche's Ocrevus Zunovo for Multiple Sclerosis with Halozyme's Enhanze Technology

  • The FDA has approved Roche's Ocrevus Zunovo, a subcutaneous formulation for relapsing and primary progressive multiple sclerosis, utilizing Halozyme's Enhanze drug delivery technology.
  • Ocrevus Zunovo offers a twice-yearly, approximately ten-minute subcutaneous injection, providing greater flexibility for healthcare providers and patients based on individual needs.
  • The approval is based on the Phase III OCARINA II trial, which demonstrated non-inferior levels of Ocrevus in the bloodstream and comparable safety and efficacy to the intravenous formulation.
  • The trial showed a 97% effectiveness rate in suppressing relapse activity and MRI lesions through 48 weeks, with over 92% of participants reporting satisfaction with the subcutaneous administration.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial for Idiopathic Pulmonary Fibrosis

• Nerandomilast met the primary endpoint in the FIBRONEER-IPF trial, demonstrating a statistically significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo. • The FIBRONEER-IPF trial, involving over 1177 patients across more than 30 countries, stands as the largest IPF trial conducted to date. • Boehringer Ingelheim plans to submit a new drug application to the FDA and other health authorities based on these positive results, seeking approval for nerandomilast in treating IPF. • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, has received Breakthrough Therapy Designation from the FDA for IPF, highlighting its potential to address unmet needs.

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

NCT05321082CompletedPhase 3
Boehringer Ingelheim
Posted 11/16/2022

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321069CompletedPhase 3
Boehringer Ingelheim
Posted 10/6/2022

Epitomee Medical's Weight Loss Pill Receives FDA Approval, Stock Surges

  • Epitomee Medical's weight loss pill has secured FDA approval, marking a significant milestone for the company in a competitive market.
  • Following the FDA's decision, Epitomee's stock experienced a substantial surge of 200% within two days, reflecting investor optimism.
  • The company now faces the challenge of establishing its product in a crowded weight loss market, requiring strategic market positioning.
  • This approval provides a new option for individuals seeking medical interventions for weight management, addressing a significant health need.

Ivonescimab Shows Promise in Combination Therapies for CRC, TNBC, and HNSCC

  • Ivonescimab, a bispecific antibody, demonstrates encouraging anti-tumor activity and a manageable safety profile in Phase II trials for metastatic colorectal cancer (CRC).
  • In advanced triple-negative breast cancer (TNBC), ivonescimab combined with chemotherapy achieved a 72.4% overall response rate and 100% disease control rate in first-line treatment.
  • Ivonescimab, with or without ligufalimab, shows clinical benefit in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), with overall response rates of 30% and 60%, respectively.
  • Summit Therapeutics plans to expand clinical development of ivonescimab in solid tumors beyond non-small cell lung cancer, based on positive Phase II data.

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

NCT05382442RecruitingPhase 2
Akeso
Posted 6/27/2022

A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

NCT05229497Unknown StatusPhase 1
Akeso
Posted 5/4/2022

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

NCT05227664RecruitingPhase 2
Akeso
Posted 3/23/2022

Antennova's ATN-037 Shows Promise in Checkpoint Inhibitor-Resistant Cancers

  • Antennova presented Phase I/Ib data for ATN-037, a CD73 inhibitor, at ESMO 2024, demonstrating its potential to overcome resistance to checkpoint inhibitors.
  • In NSCLC and melanoma patients resistant to CPIs, ATN-037 combined with pembrolizumab showed an overall response rate of 21.1% and a disease control rate of 89.5%.
  • The Phase I dose escalation study suggests ATN-037 can reverse resistance to anti-PD-1 therapies, warranting further investigation in Phase II trials.
  • Antennova has initiated the dose optimization and expansion phase of the Phase II STAMINA trial in Australia and plans to expand to China in late October 2024.

Regeneron's Fianlimab and Libtayo Combo Shows Sustained Melanoma Response

• Regeneron's combination therapy of fianlimab and Libtayo demonstrates continued benefit in advanced melanoma patients after two years, according to Phase I trial data. • The combination achieved a 25% complete response rate and a 57% objective response rate across three cohorts of advanced melanoma patients. • The median progression-free survival was 24 months, with the median duration of response not yet reached, indicating a durable treatment effect. • A Phase III trial comparing the combination to Keytruda is underway, with results anticipated in 2025, potentially expanding treatment options.

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

NCT05352672RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 7/14/2022

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

NCT05608291Active, Not RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 1/16/2023

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

2022-502825-17-00RecruitingPhase 2/3
Regeneron Pharmaceuticals Inc.
Posted 9/18/2024

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

NCT06246916RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 9/9/2024

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

NCT03005782CompletedPhase 1
Regeneron Pharmaceuticals
Posted 11/7/2016

Zynyz Plus Chemotherapy Shows Promise in Advanced Anal Cancer

  • Incyte's Zynyz (retifanlimab) combined with chemotherapy significantly improved progression-free survival in previously untreated patients with advanced anal cancer.
  • The Phase III POD1UM-303 trial is the first and largest study evaluating a first-line checkpoint inhibitor for advanced anal cancer, addressing a high unmet medical need.
  • Zynyz plus platinum-based chemotherapy may represent a new standard of care for patients with advanced squamous cell anal cancer, according to study presenter Sheela Rao.
  • Incyte plans to seek FDA approval for Zynyz in anal cancer based on these findings, potentially offering a new treatment option.

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Active, Not RecruitingPhase 3
Incyte Corporation
Posted 1/12/2021

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