Sigrid Therapeutics aims to ward off Type 2 diabetes with an edible, powdered medical device

Called SiPore15, Sigrid Therapeutics' silica powder recently showed reductions in HbA1c levels in a proof-of-concept study. (Sigrid)

Using a superfine, micron-sized, edible silica powder, Sigrid Therapeutics aims to prove it can help reduce blood sugar levels in people with prediabetes as well as those with newly diagnosed and untreated Type 2 diabetes.

Technically a medical device—or even a “therapeutic material”—the tasteless and odorless powder is not absorbed by the body. Instead, the porous silica particles mechanically separate digestive enzymes from pieces of food, gently slowing gastral processes. They are then eliminated from the body normally.

Called SiPore15, the product recently showed a 1.4 mmol/mol mean reduction in HbA1c levels in a proof-of-concept study with no increased safety risks or serious adverse events, according to the company.

The open-label, single-arm trial enrolled 43 obese or overweight participants for three months of treatment. Served in foil packets and mixed with water before the three main meals of the day, doses were increased from one gram per meal to the full dose of three grams per meal. 

“The reduction achieved in HbA1c with SiPore15 after 12 weeks of administration was similar to that of large, years-long studies with metformin, the only drug considered for treatment of selected prediabetes patients by the American Diabetes Association,” Sigrid Therapeutics CEO Sana Alajmovic said in a statement. The company said it plans to submit the full results for publication and presentation at a scientific conference. 

“Importantly, SiPore15 was well tolerated, which is a significant competitive advantage over systemically acting drugs,” Alajmovic added. “The 12-week follow up period of the study is ongoing and we look forward to reporting final results by the end of this year, as we are working towards obtaining device clearance to market SiPore15 in the EU.”

In September, the Stockholm-based company raised $1.6 million in an equity financing round led by Joyance Partners and Pär Gellerfors, co-founder of the immunotherapy-focused BioArctic, who sits on the company’s board of directors.

They were joined by Swedish investment firm Axilium Capital, as well as Karsten Inde, founder of the private care service Team Olivia. The oversubscribed round brought Sigrid Therapeutics’ total funding up to $9 million. 

In future indications, the company aims to tweak the specific properties of the silica particles to engage different diseases, potentially including gestational and pediatric Type 2 diabetes, nonalcoholic steatohepatitis, and the modulation of the gut microbiome and bile acid levels as well as obesity and weight loss.