BioWorld International Correspondent
LONDON - NeuTec Pharma plc announced positive results from a Phase II/III study of Mycograb in treating systemic candidiasis infections and said it will file for approval in Europe.
The company plans to raise £20 to £25 million (US$37.2 million to US$46.6 million) in a placement and open offer to pay for manufacturing, sales and marketing of Mycograb, as well as new trials to widen the label.
James Burnie, CEO, told BioWorld Today the results of the Mycograb trial are very convincing.
"We plan to do the fund raising immediately, once we see how details of the trial are received in the marketplace," he said.
NeuTec is listed on the Alternative Investment Market in London, and its shares rose 38 percent to £4.97 Monday morning when the trial data were released. But the fund raising is not urgent, as the Manchester, UK-based company has £7.9 million in the bank, sufficient for more than two and a half years at the current burn rate.
Burnie expects to file for Mycograb in the next six months, and the product, which has orphan drug status in both Europe and the U.S., could be approved by this time next year. NeuTec is in discussions with the FDA over whether more work is required for U.S. registration. "It's not clear as yet," Burnie said. "These results are good, but the FDA may want a wider population of patients."
Mycograb and NeuTec's other products are recombinant antibodies based on antibodies derived originally from the blood of patients who recovered from hospital-acquired infections. The company has developed a platform technology, FabTec, for identifying and characterizing antibodies expressed in infection and responsible for an effective immune response. Subsequent investigation of the mode of action of Mycograb showed it targets the heat-shock protein 90 (Hsp90), which also is an important target in some types of cancer.
The Mycograb trial in 10 European countries and the U.S. involved 117 evaluable patients with invasive candidiasis who received conventional treatment with a lipid-based formulation of the antibiotic amphotericin B, combined with a five-day course of either Mycograb or placebo.
The primary endpoint of overall cure rate was reached, with 84 percent (47 out of 56 patients) in the Mycograb group recovering fully, compared to 48 percent (29 of 61) in the control group. To be regarded as successfully treated, patients had to show a complete clinical response and have confirmed clearance of the infection in laboratory tests at day 10.
The trial also was positive on three secondary endpoints, including lower mortality in the Mycograb-treated group of 4 percent (two of 56), compared to 18 percent (11 of 61) in the control, and faster eradication of the fungus as confirmed by laboratory tests (Mycograb three days; monotherapy 23 days).
NeuTec intends to file for Mycograb in combination with amphotericin B for the treatment of invasive candidiasis in immunocompetent intensive care patients.
The company is planning for a launch and is recruiting sales and marketing executives and selecting a contract manufacturer. To date, production has been scaled to 1,000 liters. Burnie expects further economies of scale and is confident of bringing the cost down to £1,000 per patient. NeuTec says there are 320,000 cases of systemic fungal infections per year worldwide.
If the fund raising is successful, NeuTec is planning two trials of Mycograb to extend the label to a wider number of systemic fungal infections, including cryptococcal infections and invasive aspergillosis, and for use in treating advanced cancers. Hsp90 exists in a different conformation in cancer cells from normal cells and that conformation has a greater affinity for Hsp90 inhibitors. NeuTec has in vitro data that suggest Mycograb could be used as an adjunctive treatment in breast cancer.
The fund raising also would pay for a trial of the company's second product, Aurograb, which is in Phase III work in methicillin-resistant Staphylococcus aureus infections, and for a Phase I/II trial of the next product in the pipeline for treating Clostridium difficile colitis. That is believed to be the most common cause of antibiotic-associated diarrhea in UK hospitals.
NeuTec also is developing products to treat hospital-acquired Enterococci infections; Burkholderia cepacia, an infection that occurs in cystic fibrosis patients; and a treatment for the infection E. coli 0157.