NeuroSense Therapeutics’ Post

Please consider participating in an important Phase 2a clinical trial for patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) sponsored by Spero Therapeutics. Eligible participants are either treatment-naïve or have received treatment for NTM-PD in the past and responded well. The study will compare two doses of oral SPR720 monotherapy, 500 mg and 1000 mg, with placebo (no active drug). The goal of Study SPR720-202 is to lay the groundwork for a later-stage and longer-term trial evaluating SPR720, in combination with current standard-of-care agents. For more information on eligibility, click here. https://bit.ly/3UlhsQw

Please consider participating in an important Phase 2a clinical trial for patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) sponsored by Spero Therapeutics. Eligible participants are either treatment-naïve or have received treatment for NTM-PD in the past and responded well. The study will compare two doses of oral SPR720 monotherapy, 500 mg and 1000 mg, with placebo (no active drug). The goal of Study SPR720-202 is to lay the groundwork for a later-stage and longer-term trial evaluating SPR720, in combination with current standard-of-care agents. For more information on eligibility, click here. https://bit.ly/3UlhsQw

Please consider participating in an important Phase 2a clinical trial for patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) sponsored by Spero Therapeutics. Eligible participants are either treatment-naïve or have received treatment for NTM-PD in the past and responded well. The study will compare two doses of oral SPR720 monotherapy, 500 mg and 1000 mg, with placebo (no active drug). The goal of Study SPR720-202 is to lay the groundwork for a later-stage and longer-term trial evaluating SPR720, in combination with current standard-of-care agents. For more information on eligibility, click here. https://bit.ly/3UlhsQw

Please consider participating in an important Phase 2a clinical trial for patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) sponsored by Spero Therapeutics. Eligible participants are either treatment-naïve or have received treatment for NTM-PD in the past and responded well. The study will compare two doses of oral SPR720 monotherapy, 500 mg and 1000 mg, with placebo (no active drug). The goal of Study SPR720-202 is to lay the groundwork for a later-stage and longer-term trial evaluating SPR720, in combination with current standard-of-care agents. For more information on eligibility, click here. https://bit.ly/49DZBdx

🙌 Exciting news for liver disease, as Gilead Sciences acquires CymaBay Therapeutics! The acquisition gives Gilead ownership of Seladelpar, a drug to treat Primary Biliary Cholangitis (PBC), a disease which affects the bile ducts that run through the liver. The therapy is currently under review by the FDA, following a recent Phase III RESPONSE trial, which showed statistically significant results versus a placebo. As a fellow therapy developer in the liver disease space, this news is heartening – demonstrating that persistence, adaptability, and focused execution are key to advancing novel medicines for patients. Read more about the acquisition at STAT ⬇️ #biotech #genomics #LiverDisease

Tomorrow, February 29, it’s #RareDiseaseDay. In 1983, #OrphanDrugAct was passed and brought more resources toward the research, development, and distribution of #RareDisease therapeutics. 41 years later, we celebrate the continued progress and hope within the rare disease community! If you want to support anyone with a #RareDisease, you can learn more here: bit.ly/RDD2024 #RareDiseaseDay, #LightUpForRare, #ShareYourColors, #ShowYourStripes

美国食品药品监督管理局（FDA）近期发布了三项新的指导方针，旨在扩大癌症临床试验的参与范围： 1.实验室值：建议根据药物的特性调整入选标准，以避免过于严格的实验室数值排除患者。 2.清除期及伴随用药：强调应根据具体试验需求调整清除期，并仅在确有必要时排除同时服用其他药物的患者。这对于服用多种药物的老年人群尤为重要。 3.性能状态：建建议通过调整入选标准来包括性能状态较差的患者，以提高试验的代表性和多样性。 USA Food and Drug Administration (FDA) has released 3 new guidelines for companies conduction oncology clinical trials. 1. Lab values - They recommend to consider only the lab values important for the drug and the ones which are less important to be more relaxed so more patients could qualify for the study. 2. Washout and concomitant medications - The new guideline recommends that patients are not excluded unnecessary because of concomitant medications. This is particularly relevant for older population which tends to be taking more medications. 3. Performance status - The recommendation is to consider the performance status of the patients with the medical condition rather than aiming for fit patients only. https://lnkd.in/g7gTQpRK

On May 15th we announced a partnership with Enable Injections to develop a combination product to treat advanced Parkinson's disease. Our chemistry team at Serina spent four years trying to solve the challenges of programming the release of apomorphine from our proprietary POZ polymer. We solved it. We are relentless. SER-252 is a potential breakthrough therapy for advanced disease. We anticipate entering clinical studies in 2025 with a twice per week subcutaneous injection of apomorphine that has the potential to reduce “OFF” time, with no adverse skin reactions and no need for a doctor or nurse to administer it. SER-252 is a preventive therapy (not a rescue therapy) with the potential to increase “ON” time, prevent dyskinesia, and may allow some patients to titrate off all L-DOPA. Leveraging our partnership with Enable Injections, SER-252 is being developed using enFuse®, the innovative wearable drug delivery platform from Enable that allows patient self-administration with rapid treatment time. Go to www.enableinjections.com and www.serinatherapeutics.com to learn more.

The final months of 2024 may include an onslaught of highly-anticipated drug approvals. Medicines among the list include those that target cystic fibrosis, lung cancer and the rare genetic nervous system disorder AADC deficiency and if approved, patients suffering from these conditions will enter the New Year with a number of new treatment options. Learn more on these 5 FDA decisions to watch, below. #FDA #marketaccess #drugdevelopment

On July 2, 2024, the FDA approved Kisunla (donanemab), Eli Lilly’s anti-amyloid antibody, for the treatment of mild cognitive impairment and mild dementia stages of Alzheimer’s disease making it the second approved therapeutic to demonstrated a clinical benefit.    However, whilst a significant step forward, for it and other therapeutics to realize their clinical potential, several challenges still need to be addressed: - Access to Diagnostics: Early and accurate diagnosis is critical for efficacy and eligibility to Kisunla and Leqembi, but is hindered by the need for specialized tests (CSF analysis, PET imaging). - Drug Administration: Intravenous infusions are required, which can be a barrier for patients without access to infusion centers. - Cost and Coverage: High costs with partial coverage (~$26,000/year for Leqembi; $12,522-$32,000 for Kisunla) pose financial burdens to patients. - Health Disparities: Clinical trials predominantly involved white participants, leading to a lack of data for minority populations leading to a lack of understanding within these populations and potentially affecting uptake. To learn more, have a look at this article from Lifescience Dynamics or reach out to discuss more! https://lnkd.in/eAfPRwMG