- Tetra Bio-Pharma (TSXV:TBP) has received an Orphan Drug Designation from the US FDA, for its cannabinoid topical cream, PPP004
- The designation covers the topical as a treatment for epidermolysis bullosa, a group of rare skin diseases
- Tetra Bio-Pharma will receive a number of incentives, to assist in the development of the drug
- The company is assessing the possible launch of a proof of concept trial in the coming months
- Tetra shares are up 1.67 per cent, currently trading for $0.30 per share and has a market cap of $75 million
Tetra Bio-Pharma (TSXV:TBP) has received an Orphan Drug Designation from the US FDA, for its cannabinoid topical cream, PPP004.
An “orphan drug” is one which treats rare medical conditions, and is therefore not profitable to produce without government assistance. Tetra is developing the topical, PPP004, to treat epidermolysis bullosa (EB), a group of rare skin diseases.
Epidermolysis bullosa can cause fragile, blistering skin, significant pain, and reduced quality of life. Some symptoms can be managed with lifestyle changes and home care. However, severe cases may require medication, surgery, or rehabilitation. The condition commonly worsens in spite of treatment, and can result in serious complications and death.
While PPP004 can not cure EB, it can help manage the related itching and pain, which impact quality of life. Tetra Bio-Pharma’s CSO, Dr Melanie Kelly, said that the company has completed its preclinical research into PPP004 human trials.
“We have a vast experience in the development of topicals, with the recent completion of two clinical trials with Awaye. We expect to rapidly bring this product into trials.
“In the coming days, we will be reaching out to physicians specialised in the treatment of this disease, to discuss a potential proof of concept clinical trial,” she revealed.
Tetra Bio-Pharma’s CEO and Chief Regulatory Officer, Dr Guy Chamberland, said that the company was very happy about the designation. Thanks to the US Food and Drug Administration, the company will have assistance to develop the product.
“Orphan designation qualifies PPP004 for development incentives. These include tax credits for clinical trials, 7-years of marketing exclusivity, and the marketing application is not subject to prescription drug user fees. These incentives are critically important to a small biopharma.
Tetra will be assessing to launch a proof of concept trial in the coming months. We will also be requesting a Type B meeting with the FDA to discuss the marketing requirements for this Orphan Drug indication. The company will provide an update to shareholders once the meeting is confirmed,” he said.
Tetra’s share price is up 1.67 per cent, and trading for $0.30 per share, as of 10:37am EST.