Pharmacokinetics

PureTech Launches Seaport Therapeutics with $100 Million Oversubscribed Series A and Announces Management Transitions

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Depression, Eli Lilly, Major depressive disorder, Patient, Bristol Myers Squibb, PureTech Health, PRTC, Therapy, Creativity, Disorder, General counsel, CNS, Life, DSM-IV codes, Pleasure, Pharmacokinetics, Interim, Third Rock Ventures, U.S. FDA, Schizophrenia, KarXT, Teva Pharmaceuticals, ARCH Venture Partners, Merck, Anxiety, Merck & Co., Research and development, FDA, Lymphatic system, Hepatotoxicity, Sirna Therapeutics, Generalized anxiety disorder, Growth, Neuropsychiatry, Partner, Multimedia, Eli Lilly and Company, Probability, Liver, Medicine, Pharmaceutical industry

Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.

Key Points: 
  • Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.
  • Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.
  • Eric Elenko, Ph.D., a PureTech co-founder and current Chief Innovation Officer, has been promoted to the role of President of PureTech.
  • Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics.

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

Retrieved on: 
Tuesday, April 9, 2024
Mental Health, Health, Neurology, General Health, Pharmaceutical, Biotechnology, Generalized anxiety disorder, Depression, Eli Lilly, U.S. FDA, Schizophrenia, KarXT, Major depressive disorder, ARCH Venture Partners, Patient, CNS, Anxiety, Bristol Myers Squibb, PureTech Health, DSM-IV codes, Pleasure, Neuropsychiatry, Research and development, Therapy, Pharmacokinetics, Partner, Disorder, Third Rock Ventures, Probability, FDA, Lymphatic system, Hepatotoxicity, Liver, Medicine, Pharmaceutical industry

Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.

Key Points: 
  • Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.
  • The round was co-led by ARCH Venture Partners and Sofinnova Investments along with Third Rock Ventures and Seaport founder PureTech Health.
  • Seaport is advancing a clinical-stage pipeline of novel neuropsychiatric medicines powered by its proprietary Glyph™ Technology Platform, which leverages the lymphatic system to create new medicines building on clinically validated mechanisms.
  • I am eager to support Seaport as an investor and board member as the team continues to advance its clinical-stage pipeline of novel therapeutics.”

Ligand Pharmaceuticals Announces New Topiramate Injection Data Presented at 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference

Retrieved on: 
Monday, April 8, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Epilepsy, Plasma, LGND, Conference, UMN, Seizure, Status epilepticus, Patient, Topiramate, Orphan, Pharming, Concomitant, Pharmacokinetics, University, Faculty, Safety, Poster, Food, Pharmaceutical industry

The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.

Key Points: 
  • The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.
  • The authors presented modeling and simulations of IV topiramate dosing based on previous studies conducted by UMN faculty in healthy research participants and patients.
  • Ligand licensed the rights to the IV formulation of topiramate from UMN and entered into a global license agreement with CURx Pharmaceuticals to further develop and commercialize the product.
  • “The availability of an injectable topiramate formulation will make it possible to ensure continuity of therapy.

Phanes Therapeutics' PT217 granted Fast Track Designation by the FDA

Retrieved on: 
Monday, April 8, 2024
Diagnosis, Survival, Carcinoma, Monoclonal antibody, Patient, SAN, Lung, Fast Track, Cancer, CD47, DLL3, Therapy, Safety, Pharmacokinetics, Platinum, FDA, SCLC, Food, Pharmaceutical industry

SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

Key Points: 
  • SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.
  • PT217 was also granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022.
  • "PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC and EP-NECs in various settings," said Ming Wang, Founder and CEO of Phanes Therapeutics.
  • Last month, PT886 was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

Retrieved on: 
Monday, April 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

Rhythm Pharmaceuticals Announces First Patient Dosed in Phase 1 Trial Evaluating RM-718, a Weekly MC4R-specific Agonist

Retrieved on: 
Monday, March 25, 2024
Human, Obesity, Hyperpigmentation, Hunger, Patient, Sigma receptor, Polyphagia, Safety, Pharmacokinetics, SAD, MC4R, Pharmaceutical industry

BOSTON, March 25, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the first patients have been dosed in the Company’s Phase 1 clinical trial of RM-718, an investigational, weekly melanocortin-4 receptor (MC4R)-specific agonist designed to be MC1R-sparing and to potentially avoid hyperpigmentation.

Key Points: 
  • “We are excited to begin clinical development of RM-718, our next-generation MC4R agonist,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
  • In addition, RM-718 was designed to provide a weekly dosing regimen and to avoid hyperpigmentation.”
    This Phase 1 trial is a three-part study to evaluate safety, tolerability and pharmacokinetics (PK).
  • Cohorts in Parts A and B are double-blind, placebo-controlled, and randomized 2:1.
  • Study participants will receive one weekly dose of either RM-718 or placebo in Part A, four weekly doses of either RM-718 or placebo in Part B, and four weekly doses of open-label RM-718 in Part C. RM-718 or placebo doses are administered weekly via subcutaneous injection.

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases

Retrieved on: 
Monday, March 25, 2024
I&I, TARC, Atopic dermatitis, Disease, Half-life, Patient, SAN, Heel, IND, Respiratory disease, Asthma, SQ, Clinical trial, Therapy, Safety, Pharmacokinetics, Engineering, Pharmaceutical industry

SAN FRANCISCO and WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.

Key Points: 
  • COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older.
  • Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.
  • The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers.
  • Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”

Belite Bio Announces PMDA Submission of Tinlarebant for Stargardt Disease Clinical Trial in Japan

Retrieved on: 
Friday, March 22, 2024
Retina, Medication, SAN, NDA, Adolescence, Clinical trial, Safety, Pharmacokinetics, PMDA, Therapy, DRAGON, Pharmaceutical industry

In the Phase 2 trial, 42% of Tinlarebant-treated subjects (5 out of 12) did not develop atrophic retinal lesions during the 24-month treatment period

Key Points: 
  • In the Phase 2 trial, 42% of Tinlarebant-treated subjects (5 out of 12) did not develop atrophic retinal lesions during the 24-month treatment period
    SAN DIEGO, March 22, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announces its submission to the Pharmaceuticals and Medical Devices Agency (PMDA) to initiate a clinical trial of Tinlarebant in adolescent STGD1 in Japan (“DRAGON II”).
  • The DRAGON II trial is a combination of Phase 1b open-label study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a Phase 2/3, global, multicenter, double-masked, placebo-controlled, randomized study designed to evaluate the efficacy, safety and tolerability of Tinlarebant in adolescent STGD1 subjects.
  • Approximately 60 subjects, aged 12 to 20 years old, including approximately 10 Japanese subjects, are targeted for enrollment in the Phase 2/3 portion of the trial with a 1:1 randomization (tinlarebant:placebo).
  • The data from Japanese subjects is intended to facilitate future NDA applications in Japan.

First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis

Retrieved on: 
Friday, March 22, 2024
PET/CT, Contract research organization, Biotechnology, Sarcoidosis, Disease, Patient safety, Patient, Tablet, Spirometry, Messenger, Quality of life, Biology, Royal, Fibrosis, Clinical trial, European, Arrest, Safety, Pharmacokinetics, MOC, Phase, KITE, FDA, FVC, ECG, Granuloma, Pharmaceutical industry

The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.

Key Points: 
  • The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.
  • As part of the trial, patients will take a daily fixed dose of 25 mg OATD-01 or placebo tablets for 12 weeks.
  • Patient safety will be monitored regularly through laboratory tests, neurological examinations and ECG and spirometry.
  • The study will involve approximately 20-30 centres in the US, the European Union, Norway and the UK.

Pyxis Oncology Provides Corporate Update and Reports Financial Results for Fourth Quarter and Full Year 2023

Retrieved on: 
Thursday, March 21, 2024
Research, Common stock, Ovarian cancer, IHC, Head, Therapeutic index, NSCLC, Immunotherapy, HNSCC, Patient, Neoplasm, Cohort, Tumor microenvironment, Observation, DESC, PDAC, Lung cancer, DLT, Investment, Clinical trial, Cancer, PIPE, ATM, Safety, Pharmacokinetics, Therapy, ADC, FACT, Pharmaceutical industry

BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, today reported financial results for the year and quarter ended December 31, 2023, and provided a corporate update.

Key Points: 
  • BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, today reported financial results for the year and quarter ended December 31, 2023, and provided a corporate update.
  • Approximately 54% of subjects have experienced grade 2, and 6% of subjects have experienced grade 3 treatment emergent adverse events (TEAEs).
  • As of December 31, 2023, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments of $120.8 million.
  • As of March 20, 2024, the outstanding number of shares of Common Stock of Pyxis Oncology was 58,133,375.