Form S-1/A JUPITER NEUROSCIENCES,

December 7, 2022; UNITED STATES SECURITIES AND EXCHANGE COMMISSION. REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933. 

JOTROL™ was developed together with our technology partner Aquanova AG, Darmstadt, Germany. JOTROL™ is formulated with a unique patented micellar technology that is projected to increase the bioavailability profile of resveratrol. Manufacturing technology transfers were completed in 2017 and manufacturing procedures and clinical trial supply manufacturing has been completed at Catalent Pharmaceutical Services, Inc., St Petersburg, Florida. JOTROL™ is a micellar non-aqueous solution of resveratrol delivered in a softgel capsule. Each capsule includes 100mg of resveratrol. Pre-clinical trials in mice and rats were conducted comparing JOTROL™ to micronized resveratrol, labeled to have the highest bioavailability in the nutritional market, to demonstrate that we could achieve a significantly higher bioavailability. Summary details of these studies are included in the section “Description of Business”. A Phase I dose finding pharmacokinetic (“PK”) study in healthy volunteers was completed during the first half of 2021. The study results met our targeted goals. The results from this study will be used as a cross-reference for all indications where JOTROL™ will be used in Phase II and Phase III clinical trials. The Phase I results and the FDA guidance of cross-referencing is further described in the section “Description of Business”. The Company has not discussed the use of cross-referencing in this manner with the FDA or other comparable regulatory authorities.

Design Therapeutics Reports Positive Data from Single-Ascending Dose Trial of DT-216 for the Treatment of Friedreich Ataxia and Portfolio Progress

CARLSBAD, Calif., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today reported progress across its portfolio of novel GeneTAC™ small molecules. Today’s updates include initial results on DT-216 from the company’s single-ascending dose (SAD) Phase 1 clinical trial in patients with Friedreich ataxia (FA). The results show that DT-216 was generally well-tolerated and able to overcome the frataxin (FXN) transcription impairment that causes FA, with a greater than two-fold increase in FXN mRNA in the cohort with the highest response. These data support the continued advancement of DT-216 in the ongoing multiple-ascending dose (MAD) Phase 1 trial and the anticipated Phase 2 clinical trial in FA patients, which is on track to begin in 2023.

FDA: B-NMN Can No Longer Be Sold as a Dietary Supplement in the US

December 06, 2022. Recently, the US Food and Drug Administration (FDA) said that beta-nicotinamide mononucleotide (Β-NMN) — a popular longevity supplement ingredient — is under investigation as a potential new drug. Therefore, companies can no longer market it as a dietary supplement. This decision has sparked concern among those who use NMN and the dietary supplement industry.

Ataxia Rating Scales: Content Analysis by Linking to the International Classification of Functioning, Disability and Health

Etoom, M.; Jahan, A.M.; Alghwiri, A.; Lena, F.; Modugno, N. . Healthcare 2022, 10, 2459. doi:10.3390/healthcare10122459 

 The content analysis of ataxia rating scales would help clinicians and researchers select the most appropriate scale and understand ataxic symptoms and their impact on function. It seems that SARA is the optimal scale for rapid assessment of ataxia or in busy clinical settings. UMSARS or FARS are more appropriate for the investigating the impact of ataxia on overall health, and monitoring ataxia progression and disability.

Solid Biosciences Announces Closing of Acquisition of AavantiBio and Concurrent $75 Million Private Placement

CHARLESTOWN, Mass., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced the closing of its acquisition of AavantiBio, a privately held gene therapy company focused on transforming the lives of patients with Friedreich’s ataxia and rare cardiomyopathies, including its pipeline assets and net cash. The combined company will focus on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene transfer candidate, for the treatment of Duchenne, AVB-202, a gene transfer candidate for the treatment of Friedreich’s ataxia, AVB-401 for BAG3 mediated dilated cardiomyopathy, and additional assets for the treatment of undisclosed cardiac diseases.

The French Friedreich's Ataxia Association awards a grant of 28,000 € to the IRBLleida to understand the early stages of this rare disease

Monday, December 5, 2022 

 The French Friedreich's Ataxia Association (AFAF) has awarded a €28,000 grant to the Biochemistry of Oxidative Stress research group at the Institute for Research in Biomedicine of Lleida (IRBLleida) and the University of Lleida (UdL) to better understand the early stages of the disease. This is the third time that the AFAF has financed a Lleida project and on this occasion, it will be used for a comparative study of mice of the I151F model to discern the early stages of the pathogenesis of Friedreich's ataxia.

Tele-Exercise During COVID-19: Effectiveness of an Adaptive Seated Intervention for Adults With Chronic Neurological Impairments

Devina Kumar, Amy Bialek, Ayushi Divecha, Rachel Garn, Kathleen Friel, Talita Campos; Archives of Physical Medicine and Rehabilitation, Volume 103, Issue 12, e54 - e55, doi:10.1016/j.apmr.2022.08.566

The COVID pandemic has influenced in-person physical, social, and emotional engagement for all populations across the lifespan. Individuals with CNI who require regular exercise and physical activity may demonstrate benefits from guided virtual exercise programs that foster social interaction, personal engagement and physical well-being.

Double blind trial of a deuterated form of linoleic acid (RT001) in Friedreich ataxia

David R. Lynch, Katherine D. Mathews, Susan Perlman, Theresa Zesiewicz, Sub Subramony, Omid Omidvar, Adam P. Vogel, Ana Krtolica, Nadia Litterman, Lex van der Ploeg, Frederic Heerinckx, Peter Milner & Mark Midei; J Neurol (2022). doi:10.1007/s00415-022-11501-4

The results of this study provide no evidence for a significant benefit of RT001 at the dosages tested in this Friedreich ataxia patient population.

Clinical evidence of interventions assessed in Friedreich ataxia: a systematic review

Jain P, Badgujar L, Spoorendonk J, Buesch K.; Therapeutic Advances in Rare Disease. 2022;3. doi:10.1177/26330040221139872

 Identified literature showed a considerable unmet need for therapeutic interventions that halt or slow the deteriorating nature of FA. Novel efficacious drugs should be investigated that aim to improve symptoms or slow disease progression.

Friedreich’s ataxia: major trial readouts and regulatory events to watch in 2023

www.clinicaltrialsarena.com; Analysis. November 30, 2022 

The FDA could approve the first treatment for Friedreich’s ataxia, and at least three other major trials have readouts expected by year end. All signs indicate 2023 will prove a pivotal year in Friedreich’s ataxia drug development. Reata’s omaveloxolone, which met its primary endpoint in a Phase II trial, is up for FDA approval on February 28. Meanwhile, a Phase II/III trial of PTC’s vatiquinone, a Phase I/II trial of Stealth Bio’s elamipretide, and a Phase II study of Larimar’s CI-1601 all have key results expected in 2023.