Preclinical development

Field Trip Health Ltd. Announces Completion of DMPK Studies, Engineering Batch for FT-104, Its Novel Psychedelic Compound

Retrieved on: 
Tuesday, June 15, 2021

From the combination of in-vitro and in-vivo results, Field Trip believes that the pharmacology and safety of FT-104 can be fully addressed using well-designed preclinical toxicology models.

Key Points: 
  • From the combination of in-vitro and in-vivo results, Field Trip believes that the pharmacology and safety of FT-104 can be fully addressed using well-designed preclinical toxicology models.
  • Field Trip also announced that it has secured a Good Manufacturing Practices compliant (cGMP) contract manufacturer (CMO) for FT-104 manufacturing.
  • The drug substance from the engineering batch will provide the quantities of FT-104 needed to complete formulation and preclinical development.
  • About Field Trip Health Ltd.
    Field Trip is a global leader in the development and delivery of psychedelic therapies.

Atossa Therapeutics Receives Approval from Swedish Regulators to Initiate Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density

Retrieved on: 
Friday, June 11, 2021

Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

Key Points: 
  • Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.
  • This is a critical milestone in the development of our oral Endoxifen, commented Steven Quay, M.D., Ph.D., Atossas Chairman and CEO.
  • In addition to clinical data, regulators will require that we also develop preclinical information including toxicology studies and information about manufacturing oral Endoxifen prior to regulatory approval.
  • The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability.

Novan Announces Positive Preclinical Data in SB019 COVID-19 Anti-Viral Therapy Program

Retrieved on: 
Thursday, June 10, 2021

DURHAM, N.C., June 10, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced positive preclinical results with berdazimer sodium in a SARS-CoV-2 transmission model in golden Syrian hamsters.

Key Points: 
  • DURHAM, N.C., June 10, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced positive preclinical results with berdazimer sodium in a SARS-CoV-2 transmission model in golden Syrian hamsters.
  • The intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed.
  • These preclinical data are encouraging and provide the basis that we were looking for to support continuing down the development path for SB019.
  • Further, preclinical dose-range finding studies are being conducted to inform potential human clinical trial design and dosing regimen.

OliX Pharmaceuticals Signs Agreement with LGC Biosearch Technologies to Accelerate Production of Asymmetric siRNA for the Treatment of Androgenic Alopecia

Retrieved on: 
Wednesday, June 9, 2021

Under the terms of the agreement, LGC will produce the active pharmaceutical ingredients (API) for the preclinical and clinical study of OLX104C.

Key Points: 
  • Under the terms of the agreement, LGC will produce the active pharmaceutical ingredients (API) for the preclinical and clinical study of OLX104C.
  • The program focuses on a topically administered novel hair loss treatment with the potential for reduced systemic side effects.
  • Earlier this year, OliX announced it had demonstrated efficacy in a preclinical study of OLX104C and plans to initiate clinical trials by 2022.
  • It has been privately-owned since 1996 and has diversified through internal investment and acquisitions to be an international leader in its chosen markets.

BioCelerate Continues to Help Improve Nonclinical Study Operations through Public Private Partnership with the FDA

Retrieved on: 
Monday, June 7, 2021

As part of this PPP, BioCelerate and FDA have now released two peer-reviewed publications.

Key Points: 
  • As part of this PPP, BioCelerate and FDA have now released two peer-reviewed publications.
  • This partnership combines expertise from BioCelerate and the FDA.
  • Other recent successes for BioCelerate include:
    Common Templates for Nonclinical Studies : BioCelerate launched the Nonclinical Common Report Template (NCRT) , a companion template to the Nonclinical Common Protocol Template (NCPT).
  • The toxicology database can reduce animal use by optimizing study design, thereby improving efficiency and speed of nonclinical development.

GigaGen Publishes Research Describing Potential New Avenues to Overcome Resistance to anti-PD-L1 Therapies

Retrieved on: 
Tuesday, May 25, 2021

The preclinical data describes potential new avenues to overcome resistance to anti-PD-L1 therapies.

Key Points: 
  • The preclinical data describes potential new avenues to overcome resistance to anti-PD-L1 therapies.
  • Our preclinical data shed light on the molecular mechanisms of existingcancer immunotherapies, such as anti-PD-L1 and/or anti-TGF- therapy, and hints at potential new targets and novel therapeutic approaches for overcoming resistance to anti-PD-L1 oncology therapies.
  • GIGA-564 is designed to regulate immune response specifically in the tumor microenvironment, with potential to provide superior efficacy and reduced toxicity.
  • The analysis was complemented with in vivo testing to evaluate the potential anti-tumor activity of a newly discovered target, chemokine CCL5.

Signati Medical Announces Second Animal Study Showing a New Bipolar Radio-Frequency Sealing Tool for Trans-scrotal Vasectomy.

Retrieved on: 
Monday, May 24, 2021

Providence, RI, May 24, 2021 (GLOBE NEWSWIRE) -- Signati Medical, Inc., a medical device company focused on advancing men's health with a proprietary bipolar radio frequency sealing platform, announced today that the company initiated a second preclinical study on New Zealand rabbits.

Key Points: 
  • Providence, RI, May 24, 2021 (GLOBE NEWSWIRE) -- Signati Medical, Inc., a medical device company focused on advancing men's health with a proprietary bipolar radio frequency sealing platform, announced today that the company initiated a second preclinical study on New Zealand rabbits.
  • Signati has developed a unique impedance detection algorithm and was conducting this second preclinical evaluation to further correlate the radio-frequency energy delivered to the surgical site with effective vas deferens sealing.
  • This additional preclinical study will seek to expand the positive findings of Signatis initial preclinical study on New Zealand rabbits.
  • The methods and conditions of the first study remained the same in the second study, with the addition of rabbit models conducted using a no scalpel method.

Medolife Rx Completes Initial Meeting with Bioethics Committee, Preparing for Commencement of Phase II Clinical Trial on Lead Drug Candidate

Retrieved on: 
Thursday, May 20, 2021

Additionally, throughout the preclinical trials, no patients experienced adverse effects to the drug candidate at any dosing level, establishing that the drug is safe and non-toxic.

Key Points: 
  • Additionally, throughout the preclinical trials, no patients experienced adverse effects to the drug candidate at any dosing level, establishing that the drug is safe and non-toxic.
  • \xe2\x80\x9cFor many pharmaceutical companies, getting to a Phase II trial can take decades due to many formulation adjustments, bad outcomes and redesigning of program constructs.
  • Patients will then be observed with noticeable changes recorded, where we believe we have an extremely high chance of success.
  • Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results.

Maxwell Biosciences Announces the CLAROMER™ Brand Biotech Therapeutics Platform as It Advances Toward Clinical Trials

Retrieved on: 
Tuesday, May 18, 2021

This paper in the Swiss journal Pharmaceuticals (MDPI) shows CryoEM images of treated viruses, obtained at the University of Texas, revealing that CLAROMER platform product candidates directly disrupt viral envelopes; this renders viral particles non-infective.

Key Points: 
  • This paper in the Swiss journal Pharmaceuticals (MDPI) shows CryoEM images of treated viruses, obtained at the University of Texas, revealing that CLAROMER platform product candidates directly disrupt viral envelopes; this renders viral particles non-infective.
  • CLAROMERs are stable in vivo and are straightforward to manufacture by solid-phase synthesis techniques and to purify by HPLC.
  • Maxwell\xe2\x80\x99s CLAROMER\xe2\x84\xa2 brand anti-infectives platform outputs a diverse array of structures demonstrated to destroy a broad spectrum of viruses, as shown in preclinical studies and imaging of viral structures.
  • They have also been shown in preclinical studies to be well tolerated in human tissues in vitro and in vivo animal studies.

Summit Therapeutics Announces Preclinical Candidate and Associated CARB-X Funding Support for the Treatment of Infections Caused by Carbapenem-Resistant Enterobacteriaceae, a CDC Urgent Threat and WHO Critical Priority

Retrieved on: 
Tuesday, May 18, 2021

Simultaneously, Summit has received an award from CARB-X to progress this candidate through preclinical development and Phase 1a clinical trials.

Key Points: 
  • Simultaneously, Summit has received an award from CARB-X to progress this candidate through preclinical development and Phase 1a clinical trials.
  • \xe2\x80\x9cSMT-738 has the potential to save the lives of patients with as yet untreatable infections through a novel drug class with a low propensity for resistance development.
  • CARB-X is investing up to US$480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines and rapid diagnostics.
  • Commercialization of ridinilazole for the treatment and the reduction of recurrence of CDI is subject to regulatory approvals.