About mDAPTA

Q1. What is mDAPTA?

A1. Treatments are available to help slow the progression of HIV and reduce the number of deaths caused by AIDS related illnesses, but significant unmet needs remain. Current therapies are unable to reach HIV ‘viral reservoirs’, areas of latent virus that remain an obstacle to the complete elimination of HIV from the body. mDAPTA is a intranasal peptide therapy in Phase II clinical development for the treatment of HIV/AIDS. mDAPTA targets specific cell receptors called CCR5 receptors, which allow the HIV virus to enter healthy cells. By blocking the activity of these receptors, mDAPTA has the potential to stop the virus infecting new cells, thereby reducing the viral load. Early data suggest that mDAPTA may offer promising efficacy benefits, reducing viral load and, importantly, eliminating the HIV ‘viral reservoirs’ which current therapies are unable to reach. Studies to-date indicate that mDAPTA is very well tolerated and has not been associated with any serious adverse events.

 

Q2. How does mDAPTA work?

A2. mDAPTA targets specific cell receptors called CCR5 receptors, which allow the HIV virus to enter healthy cells. By blocking the activity of these receptors, mDAPTA has the potential to stop the virus infecting new cells, thereby reducing the viral load. Early data suggest that mDAPTA may offer promising efficacy benefits, reducing viral load and, importantly, eliminating the HIV ‘viral reservoirs’ which current therapies are unable to reach. 5 Studies to-date indicate that mDAPTA is very well tolerated and has not been associated with any serious adverse events.

 

Q3. What happened with the predecessor first generation anti-HIV compound to mDAPTA? Why was this never bought to market?

A3. DAPTA (D-Ala-Peptide T-Amide), also called Peptide T, was first developed in 1986, with initial studies demonstrating the drug’s promise as an effective treatment for HIV – trials highlighted the drug’s promising antiviral and immune benefits, and improvements in cognition in humans with HIV, suggesting its penetration into the central nervous system. However, in spite of reassuring results, studies carried out in 2003 confirmed that DAPTA formed long fibres, aggregates in a watery solution, which are biologically inactive. As such, further research was conducted to develop a formulation which allowed for a stable, non aggregated DAPTA. mDAPTA was subsequently discovered, demonstrating substantially longer stability, and approximately 100-fold greater efficacy than the previous formulation.

 

Q4. Is mDAPTA a cure for AIDS?

A4. mDAPTA is currently in Phase II clinical development for the treatment of HIV/AIDS. Early data suggest that mDAPTA is effective and well tolerated, but the full potential of mDAPTA in this indication is not yet fully established.

 

Q5. How does mDAPTA differ from other treatments for HIV/AIDS?

A5. Treatments are available to help slow the progression of HIV and reduce the number of deaths caused by AIDS related illnesses, but significant unmet needs remain. Current therapies are unable to reach HIV ‘viral reservoirs’, areas of latent virus that remain an obstacle to the complete elimination of HIV from the body. mDAPTA is a intranasal peptide therapy in Phase IIb clinical development for the treatment of HIV/AIDS. With regulatory approval, mDAPTA will be the first peptide treatment for HIV/AIDS. mDAPTA targets specific cell receptors called CCR5 receptors, which allow the HIV virus to enter healthy cells. By blocking the activity of these receptors, mDAPTA has the potential to stop the virus infecting new cells, thereby reducing the viral load. Early data suggest that mDAPTA may offer promising efficacy benefits, reducing viral load and, importantly, eliminating the HIV ‘viral reservoirs’ which current therapies are unable to reach. Studies to-date indicate that mDAPTA is very well tolerated and has not been associated with any serious adverse events. mDAPTA is a nasal spray, and does not require refrigeration for storage. This is particularly beneficial in sub-Saharan regions with limited clean water supplies and electricity.

 

Q6. How is mDAPTA administered?

A6. mDAPTA is administered nasally, allowing the drug to quickly enter the blood and brain.

 

Q7. How is mDAPTA stored?

A7. mDAPTA intranasal solution can be stored at room temperature for approximately18-months. mDAPTA dry powder is stable at room temperature for at least two years. mDAPTA does not require refrigeration.

 

Q8. When will mDAPTA be launched?

A8. Subject to the outcome of ongoing clinical trials, mDAPTA will need to go through the relevant regulatory agencies to determine launch dates.

 

Q9. How much will mDAPTA cost?

A9. Given that mDAPTA has not yet been submitted to regulatory agencies, it is too early to speculate on price.

 

Q10. Will developing countries, which have the greatest number of people infected with HIV, be able to access this treatment?

A10. RAPID strongly believes that effective medicines should be available to all and is committed to facilitating access to its products, should they gain regulatory approval, in developing countries.

 

Q11. How will RAPID Pharmaceuticals ensure mDAPTA gets to these developing countries?

A11. RAPID strongly believes that effective medicines should be available to all and is committed to facilitating access to its products, should they gain regulatory approval, in developing countries. RAPID is developing strategic partnerships with key stakeholders to discuss how best to achieve this aim.

 

Q12. Will mDAPTA be used as a monotherapy, or in combination with other agents?

A12. RAPID is currently trialling mDAPTA as an adjunct therapy to HAART.

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