Filament Health Corp

Ionis Reports Positive Phase 3 Results for Olezarsen in Hypertriglyceridemia

5 days ago

• Olezarsen demonstrated significant triglyceride reductions of 61% and 58% at 6 months with 80mg and 50mg monthly doses respectively in patients with moderate hypertriglyceridemia. • The Phase 3 Essence study met all primary and secondary endpoints, with most participants achieving triglyceride levels within normal range despite already being on standard lipid-lowering therapies. • Following recent FDA approval of olezarsen (Tryngolza) for familial chylomicronemia syndrome, these results support potential expanded indication for severe hypertriglyceridemia pending upcoming CORE and CORE2 trial data.

Jaguar Health's Crofelemer Shows Promising Results for Breast Cancer Patients with Treatment-Related Diarrhea

2 months ago

• Jaguar Health's Napo Pharmaceuticals will present significant results from its Phase 3 OnTarget study showing crofelemer's effectiveness in preventing diarrhea specifically in breast cancer patients receiving targeted therapy. • The FDA has granted Napo a Type C Meeting in Q2 2025 to discuss the positive responder analysis in the breast cancer subgroup, which comprised 183 of the 287 total participants in the pivotal trial. • While the initial OnTarget study did not meet its primary endpoint across all tumor types, subgroup analysis revealed statistically significant benefits for breast cancer patients, potentially addressing a critical side effect that often leads to cancer treatment modifications.

Filament Health's Botanical Psilocybin Shows Promise in Reducing Alcohol Consumption in Phase 2 Trial

2 months ago

• A single 25mg dose of PEX010, Filament Health's botanical psilocybin drug candidate, reduced heavy drinking days by more than 50% over 12 weeks in patients with alcohol use disorder. • The open-label Phase 2 study at Psychiatric Centre Copenhagen demonstrated significant decreases in alcohol consumption, cravings, and temptation, with a favorable safety profile and no serious adverse events. • Researchers are now advancing to a larger randomized, placebo-controlled trial to establish firm conclusions about PEX010, which is currently authorized for investigation in 51 clinical trials worldwide for 14 mental health indications.

Filament Health's Botanical Psilocybin PEX010 to be Studied in Neuroplasticity Trials at UW-Madison

4 months ago

• Filament Health has shipped its botanical psilocybin drug candidate, PEX010, to the University of Wisconsin-Madison for use in two FDA-authorized clinical trials. • The trials will investigate the effects of psilocybin on neuroplasticity and its potential therapeutic benefits for mental health conditions. • The ENHANCE Study will explore the impact of psychedelics on expanding the "Perception Box" in 100 healthy volunteers. • The RECAP2 Study will examine the long-term effects of psilocybin on wellbeing in 60 healthy volunteers with mild declines in mental health.

Gene Therapy Trial for Geographic Atrophy Shows Limited Efficacy Despite Sustained Factor I Expression

5 months ago

A Phase I/II clinical trial of PPY988, an AAV2-CFI gene therapy for geographic atrophy, demonstrated sustained elevation of complement Factor I levels but insufficient potency compared to existing treatments. The study provides crucial insights for future complement-targeting gene therapies while confirming complement modulation as a viable therapeutic approach for age-related macular degeneration.

Jaguar Health Advances Crofelemer Trials for Rare Diarrheal Diseases

6 months ago

• Jaguar Health has initiated multiple clinical trials to evaluate crofelemer for treating rare diarrheal diseases, including Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Microvillus Inclusion Disease (MVID). • Crofelemer, a plant-based drug, has received Orphan Drug Designation from the FDA and EMA for both SBS-IF and MVID, potentially expediting its development and market access. • Clinical trials include investigator-initiated studies and Phase 2 trials across the US, EU, and MENA regions, with initial proof-of-concept results expected as early as H1 2025. • These trials aim to address unmet needs in treating severe diarrhea and malabsorption in pediatric and adult patients, potentially leading to reimbursed early patient access in certain EU countries.

Jaguar Health's Napo Therapeutics Advances Crofelemer for Rare Intestinal Diseases in Europe

6 months ago

• Napo Therapeutics, a Jaguar Health company, has been recognized as 'Best Pharmaceuticals Innovator of the Year - Europe'. • Crofelemer, a plant-based drug, is being advanced for microvillus inclusion disease (MVID) and short bowel syndrome (SBS). • Proof-of-concept study results for crofelemer in MVID and SBS are expected by the end of 2024 and throughout 2025. • Phase 2 trials for crofelemer in MVID and SBS are planned to start before the end of 2024, potentially supporting early patient access in the EU.

Filament Health Revenue Plummets Amidst Advancing Psychedelic Drug Trials

6 months ago

• Filament Health's revenue declined by 94% in the third quarter, dropping to $19,021 from $337,470 in the same period last year, highlighting financial challenges. • Despite financial constraints, the company secured 20 new patents and advanced clinical trials for its lead candidate PEX010, including a Phase II trial for methamphetamine use disorder. • Filament Health is actively seeking additional financing to sustain operations and continue its psychedelic drug development programs, given its current cash reserves of $878,717.

FDA Grants Renewal for Canalevia-CA1 for Canine Chemotherapy-Induced Diarrhea

6 months ago

• The FDA has approved the renewal of Canalevia-CA1 (cofelemer delayed-release tablets) for treating chemotherapy-induced diarrhea (CID) in dogs. • Canalevia-CA1, developed by Jaguar Health, is administered orally twice daily for at-home treatment of CID in canine patients. • The conditional approval is extended until December 21, 2025, contingent upon demonstrating substantial evidence of effectiveness for full approval. • CID is a prevalent adverse effect in dogs undergoing cancer treatment, making Canalevia-CA1 crucial for maintaining successful cancer therapy.

Canalevia-CA1 Receives FDA Renewal for Chemotherapy-Induced Diarrhea in Dogs

7 months ago

• Jaguar Health's Canalevia-CA1 receives FDA conditional approval renewal, extending availability until December 21, 2025. • Canalevia-CA1 remains the first and only FDA-approved treatment for chemotherapy-induced diarrhea (CID) in dogs. • Jaguar Health is actively progressing towards full FDA approval through a clinical field study. • The drug is accessible via major U.S. veterinary distributors, including Chewy.