Destiny Pharma. Regulatory News (DEST)

Destiny Pharma plc

("Destiny Pharma" or the "Company")

Destiny Pharma announces start of a new XF-73 research programme

Aim to test XF-73 as a potential preventive medicine for Oral Mucositis

Oral Mucositis is a common and devastating complication from chemotherapy and radiotherapy suffered by more than 2m cancer patients every year

Brighton, United Kingdom - 05 July 2022 - Destiny Pharma plc (AIM: DEST), a clinical-stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces that it has started a new research programme. The research study will be conducted in the US by Oral Mucositis ("OM") expert Professor Stephen Sonis and will investigate the potential of XF-73 as a preventive medicine to alleviate suffering from OM in patients receiving cancer treatment by testing its efficacy in the gold-standard model of OM.

The potential utility of XF-73 in this indication is due to the long-recognised association between the development of OM and changes in the oral microbiome. The unique antimicrobial properties of XF‑73 have already been demonstrated in Phase 2 clinical trials. As well as having fast-acting antimicrobial activity and a novel mechanism of action, XF-73 has an excellent safety profile and a lack of systemic exposure which means that it is ideally suited for development as an innovative oral formulation to reduce the severity of OM.

Inflammation of the mucosa (mucositis) is considered one of the most serious non-hematological complications of cancer treatment and a common dose-limiting complication of high-dose radiotherapy and chemotherapy in cancer and bone marrow transplant patients of all ages. Globally, more than two million cancer patients suffer from this condition each year. The global OM market was estimated at $2.2b in 20181.

Despite its frequency and devastating impact, there are few approved preventive or treatment options available to help patients suffering from OM. Professor Stephen Sonis, DMD, DMSc, is a Professor of Oral Medicine at the Harvard School of Dental Medicine and also CSO at Biomodels, LLC. Prof. Sonis is a leading OM expert and his development of predictive research models has enabled investigation of the biological basis of cancer regimen-related epithelial injury in over 100 projects.

Neil Clark, Chief Executive Officer of Destiny Pharma, added: "Oral Mucositis is a very serious condition affecting millions of cancer patients across the world and is poorly treated by current products. A successful preventative product will save healthcare costs and improve patient care whilst supporting a stronger patient to complete their full course of treatment and thereby make a significant contribution to improved clinical outcomes. This new project utilises the unique profile of our XF platform in a new cancer related indication and we look forward to testing its potential in gold-standard OM models."

ENDS

For further information, please contact:

Destiny Pharma plc Neil Clark, CEOShaun Claydon, CFO+44 (0)1273 704 440 pressoffice@destinypharma.com

Optimum Strategic Communications Mary Clark / Manel Mateus / Eleanor Cooper+44 (0) 203 922 0891 DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Broker) Geoff Nash / Kate Bannatyne / George Dollemore, Corporate FinanceAlice Lane / Nigel Birks / Harriet Ward, ECM+44 (0) 207 220 0500

MC Services AG Anne Hennecke / Andreas Burckhardt+49-211-529252-12

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COVTM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

Notes to Editors

About Oral Mucositis

Inflammation of the mucosa (mucositis) is a common dose limiting complication of high dose radiotherapy and chemotherapy in cancer patients of all ages. It can affect the mucosa of the entire gastrointestinal system from oral cavity to anus. Oral Mucositis ("OM") is common and occurs in 40-70% of patients undergoing high dose radiotherapy and chemotherapy. OM is responsible for reduction or cessation of cancer treatment in 35% of patients, impacting the clinical outcome interventions (Sonis, 2014). 

Despite its frequency and impact there are few approved preventive or treatment options. Existing treatments are unsatisfactory, consisting of mouthwashes and sprays containing anaesthetics, steroids, protective hydrogels and/or local pain management.

The target market for XF-73OM is estimated at over 2m OM patients/year. The global OM market was estimated at $2.2b in 2018 (OM Market Size, Growth and Trends by Cause - 2020) and is split across countries broadly in proportion to the incidence of cancer and chemotherapy treatments. 

Smaller, targeted indications include BMT patients where severe OM is reported in >80% of patients. There are >2,000 BMTs every year in the UK and an estimated 50,000 BMTs are completed globally. 

OM patients require specialised care such as parenteral nutrition, fluid replacement and anti-infective treatment. A single point increase in peak mucositis scores in hematopoietic stem cell transplant patients is associated with one additional day of fever, a 2‑fold increase in risk of significant infection, 2.7 additional days of total parenteral nutrition, 2.6 additional days of injectable narcotic therapy, 2.6 additional days in hospital and a 3.9 fold increase in 100-day mortality risk.

The healthcare cost of OM is substantial. In the US, the estimated cost of hospitalisation was $3,893/chemotherapy cycle without OM, $6,277/cycle with OM. In one study of patients receiving radiation therapy for head and neck cancer, OM was associated with an increase in costs ranging from $1,700 - $6,000/patient, depending on the grade of OM. Costs in UK and elsewhere are similar. OM is a global condition affecting all ages, races and genders.