Latest Cutaneous Lupus Erythematosus News

Noxopharm says the FDA has supported its proposed Phase II design and chemical manufacturing strategy for SOF-SKN, its topical treatment candidate for cutaneous lupus erythematosus. The feedback improves regulatory clarity, but the trial remains targeted for the first half of calendar 2028 and is subject to further studies and regulatory requirements.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.

Noxopharm’s SOF-16 active ingredient demonstrated potent anti-inflammatory activity in patient-derived samples of systemic lupus erythematosus and rheumatoid arthritis, advancing its Sofra™ platform beyond topical applications.

Noxopharm signed a strategic MoU with Tezcat Biosciences, published major Sofra RNA research, and appointed Dr Olivier Laczka as CEO, while reporting positive safety data from its HERACLES trial and improving cash flow.

Noxopharm reports preclinical data revealing SOF-SKN’s active ingredient remains in skin tissues for about 3.5 days with minimal systemic absorption, supporting less frequent dosing and sustained activity for cutaneous lupus treatment.

Noxopharm has successfully completed the final multiple-dose cohort of its HERACLES trial for SOF-SKN™, reporting no significant safety concerns and paving the way for Phase II-enabling studies.

Noxopharm Limited reports growing interest in its Sofra technology with new research collaborations and a safe, well-tolerated HERACLES trial of SOF-SKN. The company also secures funding extensions to support ongoing development.

Noxopharm has successfully completed the third dosing phase of its HERACLES trial for SOF-SKN™, confirming safety and moving forward to the highest dose cohort in this pioneering autoimmune drug study.

Noxopharm Limited has successfully completed the second dose cohort in its HERACLES Phase 1 trial for SOF-SKN™, confirming safety and tolerability and moving forward to a higher dose. This progress marks a key step in developing a novel autoimmune disease treatment.

Noxopharm Limited has successfully completed the first low-dose cohort in its HERACLES clinical trial for SOF-SKN™, clearing the way for higher dose testing in autoimmune disease treatment.