Second Affiliated Hospital Zhejiang University College of

TUESDAY, Sept. 3, 2024 -- Four weeks of low-frequency repeated transcranial magnetic stimulation (rTMS) positively impacts poststroke urinary incontinence, according to a study published online Aug. 8 in Scientific Reports . Jialu Chen, from the Second Affiliated Hospital of Chongqing Medical University in China, and colleagues investigated the therapeutic effect of low-frequency rTMS on the contralesional primary motor cortex (M1) in 100 patients with poststroke urinary incontinence. The analysis included patients randomly assigned to the rTMS group or a sham-rTMS group. The researchers found that after four weeks of intervention, the maximum cystometric capacity, maximum detrusor pressure, residual urine output, overactive bladder score (including frequency, urgency, and urgency urinary incontinence), and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form improved significantly in the rTMS group versus the sham-rTMS group. No changes in pelvic floor muscle electromyography were detected in patients in either group. "Future clinical experiments aimed at determining the effectiveness of rTMS for poststroke urinary incontinence patients should be based on the timing and degree of damage, which could result in more effective rTMS programs," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

SHANGHAI, China, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced the successful completion of two randomized, double-blind, placebo-controlled, multi-center phase III clinical studies (Study nos.: JS002-003 and JS002-006) evaluating the company’s product ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, product code: JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, and both studies have met their primary endpoints. According to the Report on Cardiovascular Health and Diseases in China (2021), in recent years, both the blood lipid levels and the prevalence of dyslipidemia of the Chinese population have been on the rise, and dyslipidemia affects up to 40.4% of adults. Dyslipidemia, specifically the increase of low-density lipoprotein cholesterol (“LDL-C”), is the most important independent risk factor for atherosclerotic cardiovascular diseases (“ASCVDs”). The growing prevalence of dyslipidemia underscores the urgent need for effective treatments to lower LDL-C levels, which can significantly lower the incidence of ASCVDs and the risk of death. At present, the awareness, treatment, and control rates of dyslipidemia in adults in China are all relatively low. The current lipid-lowering treatment and compliance rates among individuals at high or extremely high risk of ASCVDs are concerning, and there remains a relatively significant unmet clinical demand for lipid-lowering treatments. As a new lipid-lowering drug that effectively reduces LDL-C levels, PCSK9 inhibitors have been recommended in both Chinese and overseas dyslipidemia management guidelines, and are widely recognized by clinicians. Unfortunately, there are only two imported ant-PCSK9 monoclonal antibodies currently approved for marketing in China, and no domestic anti-PCSK9 monoclonal antibody has been approved for marketing. Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody independently developed by Junshi Biosciences. Two major pivotal registered clinical studies (Study nos.: JS002-003 and JS002-006) of ongericimab have been successfully completed and met their primary endpoints. The JS002-003 study assessed the effectiveness and safety of subcutaneous injection of ongericimab for the treatment of patients with primary hypercholesterolemia and mixed dyslipidemia, while the JS002-006 study assessed the effectiveness and safety of subcutaneous injection using two drug delivery systems (pre-filled syringes and pre-filled automatic syringes) of ongericimab for the same indications. Ongericimab exhibited significant lipid-lowering efficacy in both studies with good safety. “The emergence of PCSK9 inhibitors has provided better treatment options for dyslipidemia patients, particularly those at high or extremely risk of ASCVD,” said Academician Yaling HAN from the General Hospital of Northern Theatre Command. “The positive results of ongericimab’s phase III clinical trials are very encouraging and show comparable efficacy and safety to similar PCSK9 inhibitors from overseas. We look forward to the launch of ongericimab to address unmet medical needs, and we hope the incidence and mortality of cardiovascular disease could decrease in China.” “I’m pleased to see a Chinese-developed anti-PCSK9 monoclonal antibody delivering such outstanding lipid-lowering outcomes,” said Professor Shuiping ZHAO from the Second Xiangya Hospital of Central South University. “This will equip our clinicians with more lipid-lowering treatment options and benefit countless patients in China. The management of the Chinese population’s blood lipid levels requires continuous improvement, and we expect ongericimab to contribute greatly to this process.” “I’m excited to witness the simultaneous success of two phase III studies examining ongericimab,” said Dr. Jianjun ZOU, the President of Global Research and Development at Junshi Biosciences. “These achievements were only possible through the joint efforts and dedication of researchers, patients, and R&D teams. With China entering an aging society, we hope that ongericimab can provide additional treatment options for hyperlipidemia patients and address unmet medical needs.” About Ongericimab (JS002) Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody independently developed by Junshi Biosciences for the treatment of primary hypercholesterolemia and mixed hyperlipidemia. Junshi Biosciences is the first company in China to obtain clinical trial approval for the target drug. The company has completed Phase III clinical studies in patients with primary hypercholesterolemia and mixed hyperlipidemia, and Phase II clinical studies in patients with homozygous familial hypercholesterolemia. The enrollment of patients for Phase III clinical studies of heterozygous familial hypercholesterolemia has been completed. About Junshi BiosciencesFounded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. In 2021, JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 administered with bamlanivimab, was granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116 (deuremidevir hydrobromide), a novel oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, has been approved for marketing in China and Uzbekistan. The JS016 and VV116 programs are a part of the company’s continuous efforts towards innovation for disease control and prevention of the global pandemic. Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

SOUTH SAN FRANCISCO, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today reported financial results for the quarter ended June 30, 2022 and provided a corporate update. “In the second quarter, we presented promising trial results from TPST-1120, our novel PPARα antagonist, at the ASCO Annual Meeting. This was the first presentation of clinical data from a Tempest program: a significant milestone for the company that was enhanced by its selection for a podium presentation,” said Stephen R. Brady, chief executive officer of Tempest. “In addition to progress on our other programs, we closed a financing with support from both a new, top-tier investor and our founding investor that extended Tempest’s runway into the first quarter of 2024, providing additional stability during this turbulent time in the biotech capital markets.” Recent Highlights TPST-1120 (clinical PPARα antagonist): (i) presented data from the monotherapy and combination therapy arms of the TPST-1120 Phase 1 study in an oral presentation at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting; (ii) hosted a well-attended investor event at ASCO during which multiple key thought leaders discussed Tempest’s programs; and (iii) continued enrollment in a first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented a “trials in progress” poster for the ongoing TPST-1495 Phase 1 monotherapy and combination therapy clinical trial at ASCO; and (iii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) 2022 Annual Meeting.TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR 2022 Annual Meeting.Financing: closed $15 million private investment in public equity (PIPE) financing with new investor, EcoR1 Capital, and founding investor, Versant Venture Capital. Planned Near-Term Milestones TPST-1120 (clinical PPARα antagonist): early data from the first 40 patients in the first-line randomized global Phase 1b/2 study in patients with HCC under a collaboration with F. Hoffmann La Roche expected by year end or early 2023. TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023, with planned presentation of the combined data in 2023.TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022. Financial Results Second Quarter Tempest ended the second quarter of 2022 with $51.6 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $15.5 million offset by proceeds from the PIPE financing of $14.5 million (net of issuance costs). Net loss and net loss per share for the second quarter of 2022 were $9.2 million and $0.79, respectively, compared to $7.1 million and $7.63, respectively, for the second quarter of 2021.Research and development expenses for the second quarter of 2022 were $5.7 million compared to $4.2 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.General and administrative expenses for the second quarter of 2022 were $3.1 million compared to $2.6 million for the same period in 2021. The increase of $0.5 million was primarily due to higher professional and consulting fees and insurance expense as a result of operating as a publicly-traded company. Year-to-Date Net cash used in operations for the six months ended June 30, 2022 was $15.5 million.Net loss and net loss per share for the six months ended June 30, 2022 were $17.7 million and $1.88, respectively, compared to $12.4 million and $17.30, respectively, for the same period in 2021.Research and development expenses for the six months ended June 30, 2022 were $10.8 million compared to $7.8 million for the same period in 2021. The $3.0 million increase was primarily due to expanded research and development efforts and higher personnel-related costs.For the six months ended June 30, 2022, general and administrative expenses were $6.2 million compared to $4.1 million for the same period in 2021. The increase of $2.1 million was primarily due to an increase in professional and consulting fees and higher insurance expense as a result of operating as a publicly-traded company. About Tempest Therapeutics Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both tumor-targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s two novel clinical programs are TPST-1120 and TPST-1495, antagonists of PPARα and EP2/EP4, respectively. Both programs are advancing through clinical trials designed to study both agents as monotherapies and in combination with other approved agents. Tempest is also developing an orally-available inhibitor of TREX-1, a DNA repair enzyme that controls activation of the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. Tempest is headquartered in South San Francisco. More information about Tempest can be found on the company’s website at www.tempesttx.com. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. (“Tempest Therapeutics”). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding the timing and selection of development candidates, dose selection or commencement of, or availability of data from, clinical trials, the company’s guidance regarding cash resources, as well as our operational plans and the timing and ability to deliver on value-creating milestones. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement. These and other risks are described in greater detail in the Form 10-Q filed by Tempest Therapeutics with the Securities and Exchange Commission on August 15, 2022. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics. TEMPEST THERAPEUTICS, INC.Consolidated Balance Sheets(in thousands) June 30, 2022 December 31, 2021Assets Current assets Cash and cash equivalents$51,621 $51,829 Insurance recovery of legal settlement 15,000 15,000 Prepaid expenses and other current assets 1,686 2,134 Total current assets 68,307 68,963 Property and equipment, net 1,011 1,113 Operating lease right-of-use assets 1,553 3,051 Other noncurrent assets 480 111 Total assets$71,351 $73,238 Liabilities and Stockholders' Equity Current liabilities Accounts payable$1,448 $991 Accrued legal settlement 15,000 15,000 Current loan payable 2,000 - Accrued expenses and other 2,824 2,501 Current operating lease liabilities 1,050 1,442 Interest payable 101 92 Total current liabilities 22,423 20,026 Loan payable, net 13,301 15,069 Operating lease liabilities 695 2,026 Total liabilities 36,419 37,121 Stockholders' equity Common stock 10 7 Additional paid-in capital 152,644 136,173 Accumulated deficit (117,722) (100,063)Total stockholders' equity 34,932 36,117 Total liabilities and stockholders' equity$71,351 $73,238 TEMPEST THERAPEUTICS, INC.Consolidated Statements of Operations(in thousands except per share amounts) Three months ended Three months ended Six months ended Six months ended June 30, 2022 June 30, 2021 June 30, 2022 June 30, 2021Expenses: Research and development$5,651 $4,229 $10,760 $7,821 General and administrative 3,123 2,556 6,175 4,091 Total expenses 8,774 6,785 16,935 11,912 Operating loss (8,774) (6,785) (16,935) (11,912) Other income (expense), net: Interest expense (464) (276) (797) (507)Interest and other income, net 70 3 73 6 Net loss$(9,168) $(7,058) $(17,659) $(12,413)Net loss per share$(0.79) $(7.63) $(1.88) $(17.30) Investor Contacts:Sylvia WheelerWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com 1 If approved by the FDA