Tetra Bio Pharma Inc (OTCMKTS:TBPMF) has announced the receipt of US FDA orphan drug designation for its Cannabinoid PPP004 for the treatment of Epidermolysis Bullosa. It has also received orphan drug designation from the US FDA for its synthetic cannabinoid PPP003 to prevent proliferative vitreoretinopathy.
Epidermolysis Bullosa causes blistering and fragile skin. Patients suffering from this rare disease experience reduced quality of life and significant pain. Home care and lifestyle changes help to manage the pain. If the patient is unable to manage the pain, a further treatment that comprises rehabilitation, surgery, and medications is recommended. Despite offering the treatment, the progressing disease can cause several complications and even death.
PPP004 helps to cure itch and pain in patients suffering from Epidermolysis Bullosa. Chief Scientific Officer of Tetra Bio, Dr. Melanie Kelly, said the company has completed preclinical human trials of PPP004. The company has a vast experience in developing topicals. It has recently completed two clinical trials using Awaye. The company expects to bring PPP004 into trials.
PPP004 qualifies for development initiatives
CRO and Chief Executive Officer of Tetra Bio, Dr. Guy Chamberland, said the company is excited to receive orphan drug designation for PPP004 from FDA. With FDA nod, PPP004 qualifies for development initiatives like seven years of marketing exclusivity, tax credits for clinical trials, and 505(b)(1) NDA application. According to Chamberland, such incentives are essential for small pharma companies like Tetra Bio. The company will assess to launch a proof of concept trial soon. It will also request a meeting with the FDA for discussing the marketing needs for PPP004, which is a blend of CBD and THC.
Synthetic cannabinoid PPP003 prevents proliferative vitreoretinopathy
The life-threatening condition – proliferative vitreoretinopathy (PVR) is developed in 50% of the patients, who suffers from open globe surgery, and in 10% of the patients, who have undergone reparative primary retinal detachment surgery.
Surgical intervention always does not offer successful results. Kelly said synthetic cannabinoid – PPP003 prevents PVR by activating the type 2 cannabinoid receptor. If the clinical trial of PPP003 is successful in preventing the PVR in humans, it would be the first approved drug to treat PVR.
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