8-K: DiaMedica Therapeutics Expands DM199 Clinical Program into Preeclampsia

DiaMedica Therapeutics announces the expansion of its DM199 clinical program into preeclampsia, initiating a Phase 2 trial in Q4 2024 with key results expected in the first half of 2025.

Summary

• DiaMedica Therapeutics is expanding its clinical program for DM199 into preeclampsia, a life-threatening pregnancy-related vascular disorder.
• The company plans to initiate a Phase 2 investigator-sponsored trial in Q4 2024, with proof-of-concept results expected in the first half of 2025.
• The trial will enroll up to 120 participants and is estimated to cost approximately $1.5 million.
• DM199 has shown potential to lower blood pressure and improve placental perfusion, which are key factors in preeclampsia.
• The Phase 2 trial will be conducted in three parts, focusing on safety, blood pressure reduction, and impact on intrauterine blood flow.
• The company has completed animal studies showing that DM199 does not cross the placental barrier, suggesting a potential safety advantage.
• The trial will be conducted at Tygerberg Hospital in South Africa, in collaboration with DiaMedica.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with the expansion of the DM199 program into a new therapeutic area with a significant unmet need. The planned trial is cost-effective and has the potential to provide robust proof of concept. The company has also secured the collaboration of leading academics and trialists in the field of preeclampsia. However, there are risks associated with the trial, including the possibility of unfavorable results or adverse events.

Positives

• DM199 has shown potential to lower blood pressure, enhance endothelial health, and improve perfusion to maternal organs and the placenta.
• The planned trial is highly capital efficient, with an estimated cost of approximately $1.5 million.
• The company has completed studies on fertility, embryofetal development, and preand post-natal development in animal models, which support the potential safety in pregnant humans.
• The trial is investigator-sponsored, which will not significantly consume DiaMedica's clinical resources.
• The company has secured the collaboration of leading academics and trialists in the field of preeclampsia.

Negatives

• The trial is still in the planning stages and is subject to regulatory approvals.
• The company is relying on third parties to conduct the clinical trials.
• There are risks associated with the trial, including the possibility of unfavorable results or adverse events.

Risks

• The planned clinical expansion into preeclampsia is subject to regulatory approvals and may face delays.
• There is a risk of unfavorable results from the planned DM199 Phase 2 trial for preeclampsia.
• The company may face challenges in site activations and enrollment for the trial.
• There is a risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials.
• The company's ability to continue to obtain funding for its operations is a risk.
• The COVID-19 pandemic, hospital staffing shortages, and global supply chain issues could impact the company's business and clinical trials.

Future Outlook

DiaMedica plans to advance the DM199 program into preeclampsia with a Phase 2 trial, with the goal of demonstrating safety and efficacy and potentially addressing a significant unmet medical need. The company anticipates key proof-of-concept results in the first half of 2025.

Management Comments

• Rick Pauls, DiaMedica's President and CEO, stated that DM199 has the potential to lower blood pressure and has shown not to cross the placental barrier in animals.
• Professor Stephen Tong commented that he is optimistic about the potential of DM199 to reverse disease severity and improve blood pressure control.
• Professor Cluver stated that DM199 holds promise as a novel medication for preeclampsia.
• Lorianne Masuoka, MD, DiaMedica's Chief Medical Officer, noted that the investigator-sponsored trial will not significantly consume DiaMedica's clinical resources.

Industry Context

The expansion into preeclampsia addresses a significant unmet medical need, as there are no approved therapeutics for this condition in the U.S. or Europe. This move positions DiaMedica to potentially capture a significant market share if DM199 proves effective. The company is leveraging existing knowledge of DM199's mechanism of action and safety profile to expand into a new therapeutic area.

Comparison to Industry Standards

• Currently, there are no approved therapeutics for preeclampsia in the U.S. or Europe, making DM199 a potential first-in-class treatment.
• The standard of care for preeclampsia involves managing symptoms and delivering the baby, often prematurely, which highlights the need for new therapeutic options.
• Other companies are exploring different approaches to treating preeclampsia, including small molecule anti-hypertensives, but DM199's large molecule protein structure and potential safety advantage in pregnancy could differentiate it.
• The planned trial is relatively small and cost-effective compared to large-scale Phase 3 trials, allowing for a more efficient proof-of-concept study.

Stakeholder Impact

• Shareholders may view the expansion into preeclampsia as a positive development, potentially increasing the company's value.
• Employees may be impacted by the increased workload associated with the new clinical trial.
• Patients with preeclampsia and their families may benefit from the development of a new treatment option.
• The company's suppliers and collaborators may see increased business opportunities.

Next Steps

• Initiate the Phase 2 investigator-sponsored trial in preeclampsia in Q4 2024.
• Host a conference call on June 27, 2024, to discuss the preeclampsia program.
• Host a Preeclampsia Key Opinion Leader Event on July 29, 2024.
• Complete Part 1A of the Phase 2 trial and report topline results in the first half of 2025.

Key Dates

Keywords

preeclampsia, DM199, rinvecalinase alfa, clinical trial, pregnancy, hypertension, vascular disorder, placental perfusion, fetal growth restriction, rhKLK1