Updates from the Biopharmaceutical Sector: Paradigm Biopharmaceuticals, Actinogen Medical, and Invion

Recent updates highlight significant strides in the biopharmaceutical sector. Paradigm Biopharmaceuticals Ltd has received FDA feedback on its Phase III osteoarthritis study. Actinogen Medical Ltd has secured funding for its Alzheimer’s trial, and Invion Ltd reports promising results in prostate cancer treatment. These developments reflect ongoing progress in tackling major health challenges.

Paradigm Biopharmaceuticals (ASX:PAR) Advances with FDA Approval for Phase III Trial

Paradigm Biopharmaceuticals Ltd has received important feedback from the US Food and Drug Administration (FDA) regarding its proposed Phase III study for knee osteoarthritis. The company is working to secure approval for its drug candidate, pentosan polysulfate sodium (Zilosul), which has previously been used in veterinary medicine and to treat human bladder conditions and deep-vein thrombosis.

The FDA's response includes a detailed set of comments, confirming the proposed dosing regimen of two milligrams per kilogram body weight, administered twice weekly, as appropriate. Additionally, the FDA provided guidance on amendments to the monitoring and mitigation plan and statistical methods.

With this feedback, Paradigm plans to submit an updated protocol for its open Investigational New Drug (IND) application. The company is preparing for pre-screening and enrolment activities, with preparations underway at trial sites in the US and Australia.

Despite recent concerns about trial progress and funding, with Paradigm's shares down by two-thirds over the past year, the company has substantial "real world" evidence from hundreds of patients treated under Australia's Therapeutic Goods Administration's special access scheme. The promising results from a Phase II study last October further support Zilosul's potential.

Actinogen Medical (ASX:ACW) Secures Funding for Alzheimer’s Trial

Actinogen Medical Ltd is raising $11.1 million to support its Phase 2b/3 Alzheimer’s disease trial. This includes an $8.1 million share placement and a $3 million share purchase plan, with CEO Dr. Steve Gourlay participating with a $1 million subscription.

The funds will expedite the enrolment of 220 patients with biomarker-positive Alzheimer’s disease in the 36-week Xanamia trial. This trial is pivotal for achieving marketing approval in the US and globally. The funding will also ensure that the trial meets the necessary statistical and quality standards.

Actinogen’s drug candidate, Xanamem, is a brain tissue cortisol synthesis inhibitor. Cortisol, a stress hormone, is thought to contribute to Alzheimer’s and mild cognitive impairment when elevated over long periods. Xanamem’s approach contrasts with other Alzheimer’s drugs that target amyloid plaques, which have shown limited effectiveness.

Despite a setback in a depression trial earlier this year, where Xanamem missed its primary endpoint, the Alzheimer’s trial is well-funded and progressing. Interim results from the first 100 patients are expected by mid-2025, with final results anticipated in 2026.

Invion (ASX:IVX) Reports Promising Results in Prostate Cancer Trial

In recognition of Prostate Awareness Month, Invion Ltd has announced promising efficacy signals from a recently completed Phase II trial for its cancer photodynamic therapy. The therapy uses a combination of oxygen and light to target and kill malignant cells, potentially stimulating the immune system in the process.

The trial, conducted with Invion’s drug candidate INV-043, showed a positive response in 40% of patients, with one patient achieving a complete response, where the tumor was entirely cleared. Three months post-treatment, 44% of patients had negative Prostate Specific Membrane Antigen (PSMA) results on positron emission tomography, indicating a significant reduction in tumor markers.

The trial reported no serious adverse events, with all side effects being mild, underscoring the potential for this therapy to offer a less invasive alternative to traditional treatments for prostate cancer.

These updates highlight ongoing advancements in the biopharmaceutical sector, with each company making strides in addressing significant medical challenges through innovative therapies.